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This systematic review and meta-analysis aimed to synthesize current evidence on whether simulation-based training improves intubation outcomes compared with conventional or non-simulation-based approaches. Following PRISMA and Cochrane guidelines and registered with PROSPERO (CRD420251081086), reviewers searched PubMed, Cochrane CENTRAL, and Embase up to 6 June, 2025, identifying thirteen eligible randomized and prospective observational studies including 910 participants. Pooled analyses revealed that simulation-based training showed a trend toward higher first-attempt success (RR 1.10, 95% CI 0.99–1.22) and overall success rates (RR 1.04, 95% CI 0.97–1.11) compared to controls, though neither reached statistical significance. Time to intubation was slightly shorter in the simulation group but with wide confidence intervals (mean difference − 2.62 seconds, 95% CI -10.12 to 4.48). While the evidence suggests a possible benefit of simulation for achieving successful neonatal intubation on the first attempt, larger and better-standardized trials are needed to confirm its impact on clinical practice and to guide its optimal integration into neonatal airway training programs. Health sciences/Health care/Paediatrics Health sciences/Health care/Therapeutics Figures Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 Figure 6 Figure 7 Introduction Neonatal intubation is a difficult and complex procedure with low rates of first-pass success and high rates of complications [ 1 ]. Traditionally, a conventional laryngoscope is used to guide the placement of the tracheal tube and a handheld device with a blade and a built-in light source to perform traditional neonatal tubes that allow visualization of the vocal cords [ 2 ]. Simulation-based training in clinical training is considered a model of reality that involves a variety of techniques and professional exposure with three distinct phases: mastering clinical skills, skill acquisition, measured as having the skills to perform the task, retention(recall), measured at a time weeks or months later, and transfer, the ability to perform the acquired skills in varied environments, team members, or key equipment [ 3 , 4 ]. Among intubation tools video laryngoscopes are recommended on top preference for tracheal intubation across adults, children, infants and neonates, and even in patients with anticipated difficult airways they are easier and quicker to master than fibrotic bronchoscopes [ 5 ]. Earlier clinical trials have examined the impact of various simulation modalities such as high-fidelity, low-fidelity, and task trainers compared with standard or non-simulation-based training approaches. However, significant variability in neonatal intubation practice and success rates persists despite these efforts [ 6 ]. To date, the overall effectiveness of simulation-based training on neonatal intubation outcomes such as first-attempt success, overall success, and time to intubation has not been conclusively established through a robust meta-analysis. This systematic review and meta-analysis therefore aims to address this gap by synthesising current evidence and informing educational strategies for neonatal airway management. Methods This systematic review and meta-analysis was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 guidelines [ 7 ]. The protocol was prospectively registered with the International Prospective Register of Systematic Reviews (PROSPERO) under registration number (CRD420251081086) [ 8 ]. The objective was to synthesize high-quality evidence on the effectiveness of simulation-based training for neonatal or pediatric tracheal intubation, with a focus on procedural success, procedural time, and learner confidence. Eligibility Criteria We included randomized controlled trials, crossover trials and quasi-experimental studies that evaluated simulation-based training for neonatal or pediatric intubation among appropriate healthcare providers. Eligible populations comprised pediatric residents, neonatal fellows, NICU consultants, or other pediatric specialists and trainees involved in neonatal airway management. Studies exclusively involving undergraduate medical or nursing students without clear clinical pediatric airway responsibility were excluded. To ensure quantitative rigor, only studies that reported at least one outcome as analyzable numerical data, specifically, first attempt success rate, overall intubation success, time to intubate with mean and standard deviation (or convertible equivalents), or a validated self-reported confidence measure, were included. Studies that reported outcomes solely narratively or provided insufficient numeric detail were excluded. We accepted comparators that reflected either conventional training, no simulation, or an alternative simulation modality such as video laryngoscopy versus direct laryngoscopy, or high- versus low-fidelity simulation. Studies were required to focus explicitly on tracheal intubation. Those addressing only alternative airway techniques, such as supraglottic airway insertions, or unrelated neonatal skills such as facemask ventilation alone, were excluded. Information Sources and Search Strategy A comprehensive search strategy was developed in collaboration with an experienced medical librarian. We systematically searched three databases, PubMed, EMBASE and Cochrane Central Register of Controlled Trials from database inception to 6 June 2025. The search strategy combined controlled vocabulary (e.g., MeSH terms) and relevant keywords for concepts including “neonatal intubation,” “simulation,” “training,” “video laryngoscopy,” “success rates,” and “skills retention.” Reference lists of included studies and relevant reviews were also screened to ensure comprehensive coverage. No language restrictions were applied at the search stage; however, only full-text peer-reviewed publications available in English were retained. The full search strategy for each database, including all keywords and MeSH terms used, is provided in Supplementary Material 1. Study Selection All identified records were uploaded to Rayyan AI, and duplicate citations were removed. Two independent reviewers (F.H. and L.K.) screened all titles and abstracts to identify potentially relevant studies. Full-text articles were retrieved for all studies meeting inclusion criteria or when eligibility was uncertain. Disagreements at any stage were resolved through discussion or consultation with a third reviewer (D.L.). Data Extraction and Handling Data extraction was performed independently by two reviewers (A.A. and S.A.) using a standardized and piloted extraction form. All citations were managed using Rayyan and data were extracted into a standardized form. Any discrepancies were resolved through discussion or by consulting a third reviewer (S.K.). Extracted data included study characteristics (year, country, setting, design), population details (provider type and training level), intervention and comparator descriptions, sample sizes, and all reported quantitative outcomes. When studies reported multiple subgroups, only data for subgroups meeting the predefined eligibility criteria were extracted. For example, in Zhou et al., only the EMS and LEMS trainee groups were combined for analysis, as these reflected relevant trainee populations; midwives were excluded. Crossover trials were handled with care to avoid unit-of-analysis errors, ensuring that the participant number for each arm was accurately recorded and described. For studies reporting both pre- and post-training outcomes, only post-training values were extracted in order to maintain consistency across analyses. Any study reporting multiple time points was handled conservatively, with the latest available post-training measure selected if consistent with the other included studies. Where outcomes were reported as medians with interquartile ranges or 95% confidence intervals but not as means and standard deviations, validated statistical methods were employed to estimate the mean and standard deviation (Wan et al., 2014; Luo et al., 2018). This conversion was performed for several studies, including Monfredini et al., O’Connell and Weiner, Ozawa, and Assaad, to permit valid pooling of time-to-intubate data. When studies did not provide adequate data to calculate these measures, for example, reporting only p-values or narrative statements without raw or summary statistics, they were excluded from the final quantitative synthesis. Risk of Bias Assessment Risk of bias for each included randomized study was independently assessed by two reviewers (L.K. and S.K.) using the Cochrane Risk of Bias 2 (RoB 2) tool. Domains assessed included randomization process, deviations from intended interventions, missing outcome data, measurement of the outcome, and selection of the reported result [ 9 ]. Risk of bias for non-randomised studies was assessed using the ROBINS-I tool, focusing on confounding, selection, classification of interventions, deviations from intended interventions, missing data, measurement of outcomes, and selective reporting [ 10 ]. Any disagreements were resolved by consensus. Risk-of-bias summary figures were prepared to visually represent the judgments across included studies. Data Synthesis and Statistical Analysis Quantitative synthesis was undertaken for outcomes for which at least two studies provided sufficiently comparable data. First attempt success rates and overall success rates were treated as binary outcomes and pooled using the Mantel-Haenszel method to calculate risk ratios with 95% confidence intervals. Continuous outcomes, including time to intubate and confidence scores where available, were pooled using inverse variance methods to generate mean differences with 95% confidence intervals. A random-effects model (DerSimonian and Laird) was used throughout to account for between-study heterogeneity. Statistical heterogeneity was evaluated using the I² statistic and Cochran’s Q test. Where substantial heterogeneity was present (I² >50%), potential sources were explored through planned subgroup analyses, including simulation modality (video vs. direct laryngoscopy), simulation fidelity, and trainee experience level. Publication bias was assessed visually using funnel plots and formally tested with Egger’s test when ten or more studies were available for an outcome. All statistical analyses were performed using RevMan Version 5.4. Certainty of Evidence Certainty of evidence for each primary outcome was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach, considering risk of bias, inconsistency, indirectness, imprecision, and publication bias [ 11 ]. A Summary of Findings table is provided to present these ratings. Assistance from an Al tool (ChatGPT, OpenAI) was used to support language editing, grammar refinement, and formatting suggestions [ 12 ]. All content was critically reviewed and approved by the authors to ensure accuracy and integrity. Results Study Selection The initial search yielded a total of 106 articles. Following removal of duplicates and screening, thirteen studies met the inclusion criteria and were included in this systematic review and meta-analysis. Of these, ten were randomised controlled trials and three were prospective observational studies. The study selection process is illustrated in the PRISMA 2020 flow diagram (Fig. 1 ). The key characteristics of the included studies, including design, country, population, sample size, and risk of bias results, are summarised in Table 1 . Study Characteristics The final meta-analysis included thirteen studies comprising 10 RCTs and 3 observational studies. Three studies were conducted in the United States, three in Canada, two in Germany, two in Japan, one in Italy, and one in Saudi Arabia. The years of publication ranged from 2015 to 2024. The key characteristics of the included studies, including design, country, population, sample size, and risk of bias results, are summarised in Table 1 . Risk of Bias Assessment The risk of bias for the randomised trials was assessed using the Cochrane RoB 2 tool. One RCT was judged to be at low risk of bias, five were rated as having some concerns due to issues in the randomisation process and deviations from intended interventions, while four were judged to be at high risk due to concerns related to deviations from intended interventions, outcome measurement, and selective reporting (Fig. 2 ). For the three included observational studies, the ROBINS-I tool was applied: two studies were assessed as having moderate risk of bias and one as having serious risk of bias (Fig. 3 ). Overall Success Out of the thirteen included studies, eleven studies reported overall success as an outcome, encompassing a total of 1,236 patients (615 in the intervention group and 621 in the control group). The pooled analysis demonstrated no statistically significant difference between the simulation-based training and control groups (RR 1.04, 95% CI 0.97–1.11, p = 0.23; I² = 82%), indicating substantial heterogeneity (Fig. 4 ). Visual assessment of the funnel plot did not show clear evidence of publication bias for overall success (Fig. 7 ) First-Attempt Success First-attempt intubation success was reported by ten studies, with a total of 1,049 patients (526 in the intervention group and 523 in the control group). The results showed a trend favouring simulation-based training but did not reach statistical significance (RR 1.10, 95% CI 0.99–1.22, p = 0.09; I² = 65%), as presented in Fig. 5 . A funnel plot for first-attempt success showed no obvious asymmetry. Time to Intubation Data on time to intubation were reported by eleven studies. The pooled mean difference indicated no significant reduction in time to intubation in the simulation-based training group compared to controls (mean difference − 2.62 seconds, 95% CI − 10.12 to 4.47; p = 0.49; I² = 99%), demonstrating very high heterogeneity (Fig. 6 ). Visual inspection of the funnel plot for time to intubation did not reveal marked asymmetry. Certainty of Evidence The certainty of evidence was assessed for each primary outcome using the GRADE approach. Overall, the certainty ranged from moderate to very low, reflecting concerns related to risk of bias, inconsistency due to substantial heterogeneity, and imprecision in pooled estimates. Table 1 Study Characteristics Study ID Design Country Population Sample Size RoB Result Zhou m 2020 [ 13 ] Prospective observational study China Pediatric specialists 47 Low Binkhorst 2020 [ 14 ] Prospective observational study Netherlands Medical students 46 Low Musharaf I 2020 [ 15 ] Non-randomized crossover trial Canada Pediatric residents 26 Low Ozawa y 2019 [ 16 ] Randomized Crossover Trial Japan Pediatric residents 27 Low Nair s 2017 [ 17 ] Randomized controlled trial USA Pediatric residents 61 Low Assad 2016 [ 18 ] Randomized controlled trial Canada Pediatric residents NR Low Al wassia 2022 [ 19 ] Randomized controlled trial Saudi Arabia Pediatric residents 16 Low Parmekar 2018 [ 20 ] Randomized Crossover Trial USA Medical students 48 Low Komasawa 2015 [ 21 ] Randomized Crossover Trial Japan Junior doctors NR Low v salis 2022 [ 22 ] Randomized Crossover Trial Germany Pediatric residents 90 Low Monfredini 2024 [ 23 ] Randomized Crossover Trial Italy Pediatric residents 34 Low Gizicki 2023 [ 24 ] Randomized controlled trial Canada Pediatric residents 67 Low O'Connell 2017 [ 25 ] Randomized Crossover Trial USA Pediatric residents 110 Low Discussion This systematic review and meta-analysis evaluated whether simulation-based training improves neonatal intubation outcomes compared with conventional or no additional training. Neonatal tracheal intubation is a complex and high-risk procedure that remains challenging for healthcare providers, especially trainees with limited clinical opportunities to practise on critically ill neonates. The anatomical differences and small margin for error in this population make achieving first-pass success critical for minimising complications such as hypoxia and airway trauma [ 26 ]. Our findings show that simulation-based training trends toward better first-attempt success and overall success rates, although the pooled estimates did not reach statistical significance. This is consistent with earlier reports emphasising that repeated practice in a safe environment can enhance technical skills and procedural confidence [ 27 , 28 ]. Several studies in neonatal care have shown that simulation can bridge the gap between limited real-world exposure and the level of competence required for effective airway management [ 27 , 4 ]. Achieving intubation on the first attempt is particularly important because multiple attempts increase the risk of adverse outcomes [ 26 ]. We also observed no significant difference in time to intubation between simulation-based and conventional training. This aligns with previous evidence suggesting that while simulation helps build competence, variations in simulation fidelity, baseline trainee skills, and outcome definitions can all affect time-based measures [ 29 ]. The high heterogeneity for this outcome in our analysis suggests that future trials should adopt more standardised protocols and consistent definitions to produce more comparable results. Beyond immediate skill acquisition, simulation offers other benefits. Previous work highlights its role in skill retention and transfer to real clinical scenarios, which is particularly valuable when opportunities for direct patient practice are limited [ 28 , 5 ]. Simulation also supports non-technical skills such as teamwork and decision-making, which are essential for safe neonatal resuscitation [ 29 ]. The strengths of this review include a comprehensive search strategy, adherence to PRISMA 2020 guidelines, use of rigorous risk of bias assessments, and a transparent GRADE approach to rate the certainty of evidence. However, certain limitations must be acknowledged. The included studies varied widely in simulation type, learner backgrounds, and outcome measurement, contributing to the substantial heterogeneity observed. Several studies were single-centre with relatively small sample sizes, and the risk of bias was unclear in some domains due to insufficient reporting [ 5 ]. These limitations reduce the overall certainty of the pooled estimates. Future research should focus on larger, multicentre randomised trials with clear definitions of outcomes and standardised simulation interventions. There is also a need to investigate the long-term retention of skills acquired through simulation and whether improved training translates into better clinical outcomes for patients. Cost-effectiveness analyses would further inform whether investments in simulation-based training provide sufficient value for healthcare systems [ 30 ]. Conclusion Simulation-based training appears to offer educational benefits for improving first-attempt and overall intubation success in neonatal airway management, although these effects did not reach statistical significance in this meta-analysis. Time to intubation was similarly unaffected, with results showing high heterogeneity across studies. The overall certainty of evidence ranged from moderate to very low, reflecting methodological limitations, substantial heterogeneity, and inconsistency in study design, simulation modalities, and outcome measurement. Despite these constraints, the direction of effect consistently supports the value of simulation in building procedural competence and learner confidence. Future well-designed, multicentre randomised trials with standardised outcome measures are needed to clarify the clinical impact and guide best practices for integrating simulation into neonatal airway training curricula. Declarations Conflict of Interest: The authors declare that they have no conflicts of interest relevant to this study. Funding: This research received no specific grant or external funding. Author Contributions: Safi Ullah Khan and Faiqa Hassan conceptualised and selected the review topic. Deepa Lachhman Das performed the literature search and managed study selection in Rayyan. Title and abstract screening were conducted by Faiqa Hassan, Laiba Khalid, and Deepa Lachhman Das. Arsalan Ahmed and Sarah Aijaz completed the full-text screening and data extraction. Risk of bias assessment was performed by Laiba Khalid and Safi Ullah Khan. Data analysis was done by Muhammad Younas. The Introduction was drafted by Deepa Lachhman Das; Methods by Safi Ullah Khan; Results by Muhammad Younas; Discussion by Laiba Khalid; and Conclusion by Faiqa Hassan. All authors reviewed and approved the final manuscript. Acknowledgements: None References Moussa A, Sawyer T, Puia-Dumitrescu M, Foglia EE, Ades A, Napolitano N, et al. Does videolaryngoscopy improve tracheal intubation first attempt success in the NICUs? A report from the NEAR4NEOS. J Perinatol. 2022;42(9):1210–5. doi: 10.1038/s41372-022-01472-9 . PMID: 35922664; PMCID: PMC9362392. Antoine J, McLeod K, Jardine L, Liley HG, McLanders M. Video laryngoscopes in simulated neonatal intubation: usability study. Children (Basel). 2025;12(6):723. doi: 10.3390/children12060723 . PMID: 40564680; PMCID: PMC12191191. Zilio F, Giubilato S, Caldarola P, Ciliberti G, Di Monaco A, Sorini Dini C, et al. 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Additional Declarations There is NO conflict of interest to disclose. Supplementary Files SupplementaryMaterial1.docx Supplementary Material Cite Share Download PDF Status: Under Review Version 1 posted Editorial decision: revise 05 Sep, 2025 Review # 1 received at journal 04 Sep, 2025 Reviewer # 1 agreed at journal 15 Aug, 2025 Reviewers invited by journal 30 Jul, 2025 Submission checks completed at journal 28 Jul, 2025 First submitted to journal 25 Jul, 2025 Editor assigned by journal 25 Jul, 2025 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-7214212","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Article","associatedPublications":[],"authors":[{"id":493166199,"identity":"8dab4936-1824-4671-b697-1a3e0871c01a","order_by":0,"name":"Faiqa 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Pakistan","correspondingAuthor":false,"prefix":"","firstName":"Deepa","middleName":"Lachhman","lastName":"Das","suffix":""},{"id":493166204,"identity":"81d0981d-fc87-4311-a1d1-341d41a0c5a9","order_by":5,"name":"Muhammad Younas","email":"","orcid":"","institution":"Gomal Medical College, Dera Ismail Khan, Pakistan","correspondingAuthor":false,"prefix":"","firstName":"Muhammad","middleName":"","lastName":"Younas","suffix":""},{"id":493166205,"identity":"207b8459-c167-4264-8fba-fa0d3c369b5f","order_by":6,"name":"Sara Aijaz","email":"","orcid":"","institution":"United Medical and Dental College Karachi","correspondingAuthor":false,"prefix":"","firstName":"Sara","middleName":"","lastName":"Aijaz","suffix":""}],"badges":[],"createdAt":"2025-07-25 12:20:21","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-7214212/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-7214212/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":88236666,"identity":"f7c48514-06ce-41f6-802e-3e502d9b818e","added_by":"auto","created_at":"2025-08-04 10:25:29","extension":"jpg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":185393,"visible":true,"origin":"","legend":"\u003cp\u003ePRISMA 2020 Flow Diagram illustrating the process of study identification, screening, eligibility assessment, and inclusion in the systematic review and meta-analysis.\u003c/p\u003e","description":"","filename":"Figure1.jpg","url":"https://assets-eu.researchsquare.com/files/rs-7214212/v1/0796ecc3e9d1d994a714fb57.jpg"},{"id":88236667,"identity":"d9743e0d-1df9-447f-89d0-71a5a3acc7fb","added_by":"auto","created_at":"2025-08-04 10:25:29","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":333332,"visible":true,"origin":"","legend":"\u003cp\u003eRisk of bias summary for included randomised controlled trials, assessed using the Cochrane Risk of Bias 2 (RoB 2) tool.\u003c/p\u003e","description":"","filename":"Figure2.png","url":"https://assets-eu.researchsquare.com/files/rs-7214212/v1/a226c90ee95c7e27a886d7b9.png"},{"id":88236993,"identity":"ea0622c7-1a40-45c9-aeea-f6d364044e91","added_by":"auto","created_at":"2025-08-04 10:33:29","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":453108,"visible":true,"origin":"","legend":"\u003cp\u003eRisk of bias summary for included observational studies, assessed using the ROBINS-I tool.\u003c/p\u003e","description":"","filename":"Figure3.png","url":"https://assets-eu.researchsquare.com/files/rs-7214212/v1/ffd775a2e9c6934d9a3215fd.png"},{"id":88236992,"identity":"b3b94093-c26a-496b-8565-fa295c3d6465","added_by":"auto","created_at":"2025-08-04 10:33:29","extension":"png","order_by":4,"title":"Figure 4","display":"","copyAsset":false,"role":"figure","size":655255,"visible":true,"origin":"","legend":"\u003cp\u003eForest plot of overall intubation success comparing simulation-based training to conventional training.\u003c/p\u003e","description":"","filename":"Figure4.png","url":"https://assets-eu.researchsquare.com/files/rs-7214212/v1/29088bbdf74a7b0c98bae6ee.png"},{"id":88236673,"identity":"a97e85ae-dadb-4ac2-b2a6-bbec40c9f1c4","added_by":"auto","created_at":"2025-08-04 10:25:29","extension":"png","order_by":5,"title":"Figure 5","display":"","copyAsset":false,"role":"figure","size":402230,"visible":true,"origin":"","legend":"\u003cp\u003eForest plot of first-attempt intubation success comparing simulation-based training to conventional training.\u003c/p\u003e","description":"","filename":"Figure5.png","url":"https://assets-eu.researchsquare.com/files/rs-7214212/v1/0a9f488162a1da4fdef2f352.png"},{"id":88236668,"identity":"11fa1e75-fee9-4e0f-9357-4c3fc34b34bb","added_by":"auto","created_at":"2025-08-04 10:25:29","extension":"png","order_by":6,"title":"Figure 6","display":"","copyAsset":false,"role":"figure","size":743612,"visible":true,"origin":"","legend":"\u003cp\u003eForest plot of time to intubation comparing simulation-based training to conventional training.\u003c/p\u003e","description":"","filename":"Figure6.png","url":"https://assets-eu.researchsquare.com/files/rs-7214212/v1/f50e77621d3b73c5a9c45936.png"},{"id":88236664,"identity":"5f9b6c38-2813-4ab1-9ab5-56f8ff802afd","added_by":"auto","created_at":"2025-08-04 10:25:29","extension":"png","order_by":7,"title":"Figure 7","display":"","copyAsset":false,"role":"figure","size":5713,"visible":true,"origin":"","legend":"\u003cp\u003eFunnel plot assessing potential publication bias for the outcome of overall intubation success.\u003c/p\u003e","description":"","filename":"placeholderimage.png","url":"https://assets-eu.researchsquare.com/files/rs-7214212/v1/3932a2b18f1d5b588f364fb1.png"},{"id":88238478,"identity":"a039937f-4f82-48a6-8c39-20889a59ec34","added_by":"auto","created_at":"2025-08-04 10:49:31","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":2847277,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-7214212/v1/a544c167-7c3c-4b14-b7ff-47e9fd8697af.pdf"},{"id":88236663,"identity":"a1c13b1d-b177-4b1d-90a1-de629edb3490","added_by":"auto","created_at":"2025-08-04 10:25:29","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":11797,"visible":true,"origin":"","legend":"Supplementary Material","description":"","filename":"SupplementaryMaterial1.docx","url":"https://assets-eu.researchsquare.com/files/rs-7214212/v1/88dbeadc2d7544370b079fa8.docx"}],"financialInterests":"There is \u003cb\u003eNO\u003c/b\u003e conflict of interest to disclose.","formattedTitle":"Effectiveness of Simulation Modality on Neonatal Intubation: A Systematic Review and Meta-Analysis","fulltext":[{"header":"Introduction","content":"\u003cp\u003eNeonatal intubation is a difficult and complex procedure with low rates of first-pass success and high rates of complications [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. Traditionally, a conventional laryngoscope is used to guide the placement of the tracheal tube and a handheld device with a blade and a built-in light source to perform traditional neonatal tubes that allow visualization of the vocal cords [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eSimulation-based training in clinical training is considered a model of reality that involves a variety of techniques and professional exposure with three distinct phases: mastering clinical skills, skill acquisition, measured as having the skills to perform the task, retention(recall), measured at a time weeks or months later, and transfer, the ability to perform the acquired skills in varied environments, team members, or key equipment [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e, \u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]. Among intubation tools video laryngoscopes are recommended on top preference for tracheal intubation across adults, children, infants and neonates, and even in patients with anticipated difficult airways they are easier and quicker to master than fibrotic bronchoscopes [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eEarlier clinical trials have examined the impact of various simulation modalities such as high-fidelity, low-fidelity, and task trainers compared with standard or non-simulation-based training approaches. However, significant variability in neonatal intubation practice and success rates persists despite these efforts [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]. To date, the overall effectiveness of simulation-based training on neonatal intubation outcomes such as first-attempt success, overall success, and time to intubation has not been conclusively established through a robust meta-analysis. This systematic review and meta-analysis therefore aims to address this gap by synthesising current evidence and informing educational strategies for neonatal airway management.\u003c/p\u003e"},{"header":"Methods","content":"\u003cp\u003eThis systematic review and meta-analysis was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 guidelines [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e]. The protocol was prospectively registered with the International Prospective Register of Systematic Reviews (PROSPERO) under registration number (CRD420251081086) [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]. The objective was to synthesize high-quality evidence on the effectiveness of simulation-based training for neonatal or pediatric tracheal intubation, with a focus on procedural success, procedural time, and learner confidence.\u003c/p\u003e\u003cp\u003eEligibility Criteria\u003c/p\u003e\u003cp\u003eWe included randomized controlled trials, crossover trials and quasi-experimental studies that evaluated simulation-based training for neonatal or pediatric intubation among appropriate healthcare providers. Eligible populations comprised pediatric residents, neonatal fellows, NICU consultants, or other pediatric specialists and trainees involved in neonatal airway management. Studies exclusively involving undergraduate medical or nursing students without clear clinical pediatric airway responsibility were excluded. To ensure quantitative rigor, only studies that reported at least one outcome as analyzable numerical data, specifically, first attempt success rate, overall intubation success, time to intubate with mean and standard deviation (or convertible equivalents), or a validated self-reported confidence measure, were included. Studies that reported outcomes solely narratively or provided insufficient numeric detail were excluded.\u003c/p\u003e\u003cp\u003eWe accepted comparators that reflected either conventional training, no simulation, or an alternative simulation modality such as video laryngoscopy versus direct laryngoscopy, or high- versus low-fidelity simulation. Studies were required to focus explicitly on tracheal intubation. Those addressing only alternative airway techniques, such as supraglottic airway insertions, or unrelated neonatal skills such as facemask ventilation alone, were excluded.\u003c/p\u003e\u003cp\u003eInformation Sources and Search Strategy\u003c/p\u003e\u003cp\u003eA comprehensive search strategy was developed in collaboration with an experienced medical librarian. We systematically searched three databases, PubMed, EMBASE and Cochrane Central Register of Controlled Trials from database inception to 6 June 2025. The search strategy combined controlled vocabulary (e.g., MeSH terms) and relevant keywords for concepts including “neonatal intubation,” “simulation,” “training,” “video laryngoscopy,” “success rates,” and “skills retention.” Reference lists of included studies and relevant reviews were also screened to ensure comprehensive coverage. No language restrictions were applied at the search stage; however, only full-text peer-reviewed publications available in English were retained. The full search strategy for each database, including all keywords and MeSH terms used, is provided in Supplementary Material 1.\u003c/p\u003e\u003cp\u003eStudy Selection\u003c/p\u003e\u003cp\u003eAll identified records were uploaded to Rayyan AI, and duplicate citations were removed. Two independent reviewers (F.H. and L.K.) screened all titles and abstracts to identify potentially relevant studies. Full-text articles were retrieved for all studies meeting inclusion criteria or when eligibility was uncertain. Disagreements at any stage were resolved through discussion or consultation with a third reviewer (D.L.).\u003c/p\u003e\u003cp\u003eData Extraction and Handling\u003c/p\u003e\u003cp\u003eData extraction was performed independently by two reviewers (A.A. and S.A.) using a standardized and piloted extraction form. All citations were managed using Rayyan and data were extracted into a standardized form. Any discrepancies were resolved through discussion or by consulting a third reviewer (S.K.). Extracted data included study characteristics (year, country, setting, design), population details (provider type and training level), intervention and comparator descriptions, sample sizes, and all reported quantitative outcomes. When studies reported multiple subgroups, only data for subgroups meeting the predefined eligibility criteria were extracted. For example, in Zhou et al., only the EMS and LEMS trainee groups were combined for analysis, as these reflected relevant trainee populations; midwives were excluded. Crossover trials were handled with care to avoid unit-of-analysis errors, ensuring that the participant number for each arm was accurately recorded and described.\u003c/p\u003e\u003cp\u003eFor studies reporting both pre- and post-training outcomes, only post-training values were extracted in order to maintain consistency across analyses. Any study reporting multiple time points was handled conservatively, with the latest available post-training measure selected if consistent with the other included studies.\u003c/p\u003e\u003cp\u003eWhere outcomes were reported as medians with interquartile ranges or 95% confidence intervals but not as means and standard deviations, validated statistical methods were employed to estimate the mean and standard deviation (Wan et al., 2014; Luo et al., 2018). This conversion was performed for several studies, including Monfredini et al., O’Connell and Weiner, Ozawa, and Assaad, to permit valid pooling of time-to-intubate data. When studies did not provide adequate data to calculate these measures, for example, reporting only p-values or narrative statements without raw or summary statistics, they were excluded from the final quantitative synthesis.\u003c/p\u003e\u003cp\u003eRisk of Bias Assessment\u003c/p\u003e\u003cp\u003eRisk of bias for each included randomized study was independently assessed by two reviewers (L.K. and S.K.) using the Cochrane Risk of Bias 2 (RoB 2) tool. Domains assessed included randomization process, deviations from intended interventions, missing outcome data, measurement of the outcome, and selection of the reported result [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]. Risk of bias for non-randomised studies was assessed using the ROBINS-I tool, focusing on confounding, selection, classification of interventions, deviations from intended interventions, missing data, measurement of outcomes, and selective reporting [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]. Any disagreements were resolved by consensus. Risk-of-bias summary figures were prepared to visually represent the judgments across included studies.\u003c/p\u003e\u003cp\u003eData Synthesis and Statistical Analysis\u003c/p\u003e\u003cp\u003eQuantitative synthesis was undertaken for outcomes for which at least two studies provided sufficiently comparable data. First attempt success rates and overall success rates were treated as binary outcomes and pooled using the Mantel-Haenszel method to calculate risk ratios with 95% confidence intervals. Continuous outcomes, including time to intubate and confidence scores where available, were pooled using inverse variance methods to generate mean differences with 95% confidence intervals. A random-effects model (DerSimonian and Laird) was used throughout to account for between-study heterogeneity.\u003c/p\u003e\u003cp\u003eStatistical heterogeneity was evaluated using the I² statistic and Cochran’s Q test. Where substantial heterogeneity was present (I² \u0026gt;50%), potential sources were explored through planned subgroup analyses, including simulation modality (video vs. direct laryngoscopy), simulation fidelity, and trainee experience level. Publication bias was assessed visually using funnel plots and formally tested with Egger’s test when ten or more studies were available for an outcome. All statistical analyses were performed using RevMan Version 5.4.\u003c/p\u003e\u003cp\u003eCertainty of Evidence\u003c/p\u003e\u003cp\u003eCertainty of evidence for each primary outcome was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach, considering risk of bias, inconsistency, indirectness, imprecision, and publication bias [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e]. A Summary of Findings table is provided to present these ratings.\u003c/p\u003e\u003cp\u003eAssistance from an Al tool (ChatGPT, OpenAI) was used to support language editing, grammar refinement, and formatting suggestions [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e]. All content was critically reviewed and approved by the authors to ensure accuracy and integrity.\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003eStudy Selection\u003c/p\u003e\u003cp\u003eThe initial search yielded a total of 106 articles. Following removal of duplicates and screening, thirteen studies met the inclusion criteria and were included in this systematic review and meta-analysis. Of these, ten were randomised controlled trials and three were prospective observational studies. The study selection process is illustrated in the PRISMA 2020 flow diagram (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e). The key characteristics of the included studies, including design, country, population, sample size, and risk of bias results, are summarised in Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e.\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003cp\u003eStudy Characteristics\u003c/p\u003e\u003cp\u003eThe final meta-analysis included thirteen studies comprising 10 RCTs and 3 observational studies. Three studies were conducted in the United States, three in Canada, two in Germany, two in Japan, one in Italy, and one in Saudi Arabia. The years of publication ranged from 2015 to 2024. The key characteristics of the included studies, including design, country, population, sample size, and risk of bias results, are summarised in Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e.\u003c/p\u003e\u003cp\u003eRisk of Bias Assessment\u003c/p\u003e\u003cp\u003eThe risk of bias for the randomised trials was assessed using the Cochrane RoB 2 tool. One RCT was judged to be at low risk of bias, five were rated as having some concerns due to issues in the randomisation process and deviations from intended interventions, while four were judged to be at high risk due to concerns related to deviations from intended interventions, outcome measurement, and selective reporting (Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e). For the three included observational studies, the ROBINS-I tool was applied: two studies were assessed as having moderate risk of bias and one as having serious risk of bias (Fig.\u0026nbsp;\u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e3\u003c/span\u003e).\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003cp\u003eOverall Success\u003c/p\u003e\u003cp\u003eOut of the thirteen included studies, eleven studies reported overall success as an outcome, encompassing a total of 1,236 patients (615 in the intervention group and 621 in the control group). The pooled analysis demonstrated no statistically significant difference between the simulation-based training and control groups (RR 1.04, 95% CI 0.97\u0026ndash;1.11, p\u0026thinsp;=\u0026thinsp;0.23; I\u0026sup2; = 82%), indicating substantial heterogeneity (Fig.\u0026nbsp;\u003cspan refid=\"Fig4\" class=\"InternalRef\"\u003e4\u003c/span\u003e). Visual assessment of the funnel plot did not show clear evidence of publication bias for overall success (Fig.\u0026nbsp;\u003cspan refid=\"Fig5\" class=\"InternalRef\"\u003e7\u003c/span\u003e)\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003cp\u003eFirst-Attempt Success\u003c/p\u003e\u003cp\u003eFirst-attempt intubation success was reported by ten studies, with a total of 1,049 patients (526 in the intervention group and 523 in the control group). The results showed a trend favouring simulation-based training but did not reach statistical significance (RR 1.10, 95% CI 0.99\u0026ndash;1.22, p\u0026thinsp;=\u0026thinsp;0.09; I\u0026sup2; = 65%), as presented in Fig.\u0026nbsp;\u003cspan refid=\"Fig6\" class=\"InternalRef\"\u003e5\u003c/span\u003e. A funnel plot for first-attempt success showed no obvious asymmetry.\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003cp\u003eTime to Intubation\u003c/p\u003e\u003cp\u003eData on time to intubation were reported by eleven studies. The pooled mean difference indicated no significant reduction in time to intubation in the simulation-based training group compared to controls (mean difference \u0026minus;\u0026thinsp;2.62 seconds, 95% CI \u0026minus;\u0026thinsp;10.12 to 4.47; p\u0026thinsp;=\u0026thinsp;0.49; I\u0026sup2; = 99%), demonstrating very high heterogeneity (Fig.\u0026nbsp;\u003cspan refid=\"Fig7\" class=\"InternalRef\"\u003e6\u003c/span\u003e). Visual inspection of the funnel plot for time to intubation did not reveal marked asymmetry.\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003cp\u003eCertainty of Evidence\u003c/p\u003e\u003cp\u003eThe certainty of evidence was assessed for each primary outcome using the GRADE approach. 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colnum=\"5\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003eStudy ID\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eDesign\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eCountry\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003ePopulation\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c5\"\u003e\u003cp\u003eSample Size\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c6\"\u003e\u003cp\u003eRoB Result\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eZhou m 2020 [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e]\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eProspective observational study\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eChina\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003ePediatric specialists\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e47\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003eLow\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eBinkhorst 2020 [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e]\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eProspective observational study\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eNetherlands\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eMedical students\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e46\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003eLow\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMusharaf I 2020 [\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e]\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eNon-randomized crossover trial\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eCanada\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003ePediatric residents\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e26\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003eLow\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" 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colname=\"c3\"\u003e\u003cp\u003eUSA\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003ePediatric residents\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e61\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003eLow\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAssad 2016 [\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e]\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eRandomized controlled trial\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eCanada\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003ePediatric residents\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003eNR\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003eLow\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAl wassia\u0026nbsp; 2022 [\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e]\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eRandomized controlled trial\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eSaudi Arabia\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003ePediatric residents\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e16\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003eLow\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eParmekar\u0026nbsp; 2018 [\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e]\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eRandomized Crossover Trial\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eUSA\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eMedical students\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e48\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003eLow\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eKomasawa 2015 [\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e]\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eRandomized Crossover Trial\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eJapan\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eJunior doctors\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003eNR\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003eLow\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003ev salis 2022 [\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e]\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eRandomized Crossover Trial\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eGermany\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003ePediatric residents\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e90\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003eLow\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMonfredini 2024 [\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e]\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eRandomized Crossover Trial\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eItaly\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003ePediatric residents\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e34\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003eLow\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eGizicki 2023 [\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e]\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eRandomized controlled trial\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eCanada\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003ePediatric residents\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e67\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003eLow\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eO'Connell 2017 [\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e]\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eRandomized Crossover Trial\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eUSA\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003ePediatric residents\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e110\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003eLow\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eThis systematic review and meta-analysis evaluated whether simulation-based training improves neonatal intubation outcomes compared with conventional or no additional training. Neonatal tracheal intubation is a complex and high-risk procedure that remains challenging for healthcare providers, especially trainees with limited clinical opportunities to practise on critically ill neonates. The anatomical differences and small margin for error in this population make achieving first-pass success critical for minimising complications such as hypoxia and airway trauma [\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eOur findings show that simulation-based training trends toward better first-attempt success and overall success rates, although the pooled estimates did not reach statistical significance. This is consistent with earlier reports emphasising that repeated practice in a safe environment can enhance technical skills and procedural confidence [\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e, \u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e]. Several studies in neonatal care have shown that simulation can bridge the gap between limited real-world exposure and the level of competence required for effective airway management [\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e, \u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]. Achieving intubation on the first attempt is particularly important because multiple attempts increase the risk of adverse outcomes [\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eWe also observed no significant difference in time to intubation between simulation-based and conventional training. This aligns with previous evidence suggesting that while simulation helps build competence, variations in simulation fidelity, baseline trainee skills, and outcome definitions can all affect time-based measures [\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e]. The high heterogeneity for this outcome in our analysis suggests that future trials should adopt more standardised protocols and consistent definitions to produce more comparable results.\u003c/p\u003e\u003cp\u003eBeyond immediate skill acquisition, simulation offers other benefits. Previous work highlights its role in skill retention and transfer to real clinical scenarios, which is particularly valuable when opportunities for direct patient practice are limited [\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e, \u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]. Simulation also supports non-technical skills such as teamwork and decision-making, which are essential for safe neonatal resuscitation [\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e].\u003c/p\u003e\u003cp\u003e The strengths of this review include a comprehensive search strategy, adherence to PRISMA 2020 guidelines, use of rigorous risk of bias assessments, and a transparent GRADE approach to rate the certainty of evidence. However, certain limitations must be acknowledged. The included studies varied widely in simulation type, learner backgrounds, and outcome measurement, contributing to the substantial heterogeneity observed. Several studies were single-centre with relatively small sample sizes, and the risk of bias was unclear in some domains due to insufficient reporting [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]. These limitations reduce the overall certainty of the pooled estimates.\u003c/p\u003e\u003cp\u003eFuture research should focus on larger, multicentre randomised trials with clear definitions of outcomes and standardised simulation interventions. There is also a need to investigate the long-term retention of skills acquired through simulation and whether improved training translates into better clinical outcomes for patients. Cost-effectiveness analyses would further inform whether investments in simulation-based training provide sufficient value for healthcare systems [\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e].\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eSimulation-based training appears to offer educational benefits for improving first-attempt and overall intubation success in neonatal airway management, although these effects did not reach statistical significance in this meta-analysis. Time to intubation was similarly unaffected, with results showing high heterogeneity across studies. The overall certainty of evidence ranged from moderate to very low, reflecting methodological limitations, substantial heterogeneity, and inconsistency in study design, simulation modalities, and outcome measurement. Despite these constraints, the direction of effect consistently supports the value of simulation in building procedural competence and learner confidence. Future well-designed, multicentre randomised trials with standardised outcome measures are needed to clarify the clinical impact and guide best practices for integrating simulation into neonatal airway training curricula.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003ch2\u003eConflict of Interest:\u003c/h2\u003e\u003cp\u003eThe authors declare that they have no conflicts of interest relevant to this study.\u003c/p\u003e\u003c/p\u003e\u003ch2\u003eFunding:\u003c/h2\u003e\u003cp\u003eThis research received no specific grant or external funding.\u003c/p\u003e\u003ch2\u003eAuthor Contributions:\u003c/h2\u003e\u003cp\u003eSafi Ullah Khan and Faiqa Hassan conceptualised and selected the review topic. Deepa Lachhman Das performed the literature search and managed study selection in Rayyan. Title and abstract screening were conducted by Faiqa Hassan, Laiba Khalid, and Deepa Lachhman Das. Arsalan Ahmed and Sarah Aijaz completed the full-text screening and data extraction. Risk of bias assessment was performed by Laiba Khalid and Safi Ullah Khan. Data analysis was done by Muhammad Younas. The Introduction was drafted by Deepa Lachhman Das; Methods by Safi Ullah Khan; Results by Muhammad Younas; Discussion by Laiba Khalid; and Conclusion by Faiqa Hassan. All authors reviewed and approved the final manuscript.\u003c/p\u003e\u003ch2\u003eAcknowledgements:\u003c/h2\u003e\u003cp\u003eNone\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eMoussa A, Sawyer T, Puia-Dumitrescu M, Foglia EE, Ades A, Napolitano N, et al. Does videolaryngoscopy improve tracheal intubation first attempt success in the NICUs? A report from the NEAR4NEOS. 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Medicine (Baltimore). 2024;103(27):e38813. doi:\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1097/MD.0000000000038813\u003c/span\u003e\u003cspan address=\"10.1097/MD.0000000000038813\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"
[email protected]","identity":"journal-of-perinatology","isNatureJournal":false,"hasQc":false,"allowDirectSubmit":false,"externalIdentity":"jp","sideBox":"Learn more about [Journal of Perinatology](http://www.nature.com/jp/)","snPcode":"41372","submissionUrl":"https://mts-jper.nature.com/cgi-bin/main.plex","title":"Journal of Perinatology","twitterHandle":"@jperinatology","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"ejp","reportingPortfolio":"Nature AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":false},"keywords":"","lastPublishedDoi":"10.21203/rs.3.rs-7214212/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7214212/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003eSimulation-based training is increasingly used to address the challenges of neonatal tracheal intubation, a high-risk and infrequent procedure associated with low first-pass success and significant complications, particularly among trainees with limited opportunities for hands-on practice. This systematic review and meta-analysis aimed to synthesize current evidence on whether simulation-based training improves intubation outcomes compared with conventional or non-simulation-based approaches. Following PRISMA and Cochrane guidelines and registered with PROSPERO (CRD420251081086), reviewers searched PubMed, Cochrane CENTRAL, and Embase up to 6 June, 2025, identifying thirteen eligible randomized and prospective observational studies including 910 participants. Pooled analyses revealed that simulation-based training showed a trend toward higher first-attempt success (RR 1.10, 95% CI 0.99\u0026ndash;1.22) and overall success rates (RR 1.04, 95% CI 0.97\u0026ndash;1.11) compared to controls, though neither reached statistical significance. Time to intubation was slightly shorter in the simulation group but with wide confidence intervals (mean difference \u0026minus;\u0026thinsp;2.62 seconds, 95% CI -10.12 to 4.48). While the evidence suggests a possible benefit of simulation for achieving successful neonatal intubation on the first attempt, larger and better-standardized trials are needed to confirm its impact on clinical practice and to guide its optimal integration into neonatal airway training programs.\u003c/p\u003e","manuscriptTitle":"Effectiveness of Simulation Modality on Neonatal Intubation: A Systematic Review and Meta-Analysis","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-08-04 10:25:24","doi":"10.21203/rs.3.rs-7214212/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"revise","date":"2025-09-05T10:18:22+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"This content is not available.","date":"2025-09-04T18:24:11+00:00","index":1,"fulltext":"This content is not available."},{"type":"reviewerAgreed","content":"This content is not available.","date":"2025-08-15T11:02:57+00:00","index":1,"fulltext":"This content is not available."},{"type":"reviewersInvited","content":"","date":"2025-07-30T12:06:26+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2025-07-28T13:46:18+00:00","index":"","fulltext":""},{"type":"submitted","content":"Journal of Perinatology","date":"2025-07-25T12:15:32+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2025-07-25T12:15:32+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"
[email protected]","identity":"journal-of-perinatology","isNatureJournal":false,"hasQc":false,"allowDirectSubmit":false,"externalIdentity":"jp","sideBox":"Learn more about [Journal of Perinatology](http://www.nature.com/jp/)","snPcode":"41372","submissionUrl":"https://mts-jper.nature.com/cgi-bin/main.plex","title":"Journal of Perinatology","twitterHandle":"@jperinatology","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"ejp","reportingPortfolio":"Nature AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":false}}],"origin":"","ownerIdentity":"3419b149-668c-4d43-abb8-fe1501f1c89e","owner":[],"postedDate":"August 4th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"under-review","subjectAreas":[{"id":52368994,"name":"Health sciences/Health care/Paediatrics"},{"id":52368995,"name":"Health sciences/Health care/Therapeutics"}],"tags":[],"updatedAt":"2026-02-20T15:35:42+00:00","versionOfRecord":[],"versionCreatedAt":"2025-08-04 10:25:24","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-7214212","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-7214212","identity":"rs-7214212","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}
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