Incidence And Predictors Of Phlebites In Neonates Admitted To Nicus In Northwest Amhara Comprehensive Specialized Hospitals, Northwest Ethiopia, 2023:Multi Center Study

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Determining its incidence and predictors provides valuable evidence for stakeholders to address this issue and the potential factors contributing to phlebitis. Objective This study aims to determine the incidence and predictors of phlebitis among neonates with perinatal asphyxia admitted at the neonatal intensive care unit of West Amhara Comprehensive Specialized Hospital, Northwest Ethiopia, 2023. Method A multicentered, institution-based prospective follow-up study was conducted from May 1 to August 30, 2024, at the Northwest Amhara Region Comprehensive Specialized Hospital in Northwest Ethiopia. A systematic random sampling technique was employed, and data were collected using a data extraction checklist from the medical registry of neonates. The collected data were entered into EPI-DATA V.4.6.0.0 and analyzed using STATA V.14. The Kaplan-Meier failure curve and log-rank test were utilized, and both bivariable and multivariable Cox regression analyses were performed to identify predictors of phlebitis. Statistical significance was defined as p ≤ 0.05. Result The overall incidence of phlebitis was 20.9 per 1,000 neonate-day observations (95% CI: 17.12-25.54) during the entire follow-up period. Of the 423 neonates admitted to the NICU, 96 (22.69%) (95% CI: 18.93-26.94) developed phlebitis. Significant predictors included birth asphyxia (AHR= 2.1; 95% CI: 1.38-3.19), trials of cannulation (AHR=2.5; 95% CI: 1.01-6.36), macrosomic neonates (AHR=3.05; 95% CI: 1.17-7.96), flushed cannulas (AHR=0.54; 95% CI: 0.31-0.97), and short dwelling time (AHR=0.47; 95% CI: 0.29-0.765). Conculsion The incidence rate of phlebitis was higher than that reported in other studies. Predictors of phlebitis included birth asphyxia, the number of cannulation trials, macrosomic neonates, flushed cannulas, and shorter dwelling times. " } { "@context": "http://schema.org", "@type": "BreadcrumbList", "itemListElement": [ { "@type": "ListItem", "position": "1", "item": { "@id": "https://f1000research.com/", "name": "Home" } }, { "@type": "ListItem", "position": "2", "item": { "@id": "https://f1000research.com/browse/articles", "name": "Browse" } }, { "@type": "ListItem", "position": "3", "item": { "@id": "https://f1000research.com/articles/14-563/v1", "name": "Incidence And Predictors Of Phlebites In Neonates Admitted To Nicus..." } } ] } Home Browse Incidence And Predictors Of Phlebites In Neonates Admitted To Nicus... ALL Metrics - Views Downloads Get PDF Get XML Cite How to cite this article Demsu Gedefaw G, Genet GB, Abate AT et al. Incidence And Predictors Of Phlebites In Neonates Admitted To Nicus In Northwest Amhara Comprehensive Specialized Hospitals, Northwest Ethiopia, 2023:Multi Center Study [version 1; peer review: awaiting peer review] . F1000Research 2025, 14 :563 ( https://doi.org/10.12688/f1000research.164575.1 ) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. Close Copy Citation Details Export Export Citation Sciwheel EndNote Ref. Manager Bibtex ProCite Sente EXPORT Select a format first Track Share ▬ ✚ Research Article Incidence And Predictors Of Phlebites In Neonates Admitted To Nicus In Northwest Amhara Comprehensive Specialized Hospitals, Northwest Ethiopia, 2023:Multi Center Study [version 1; peer review: awaiting peer review] Gezahagn Demsu Gedefaw https://orcid.org/0009-0003-3584-4545 1 , Geta Bayu Genet https://orcid.org/0009-0001-3697-841X 2 , Asnake Tadesse Abate https://orcid.org/0009-0005-4669-3206 3 , [...] Wubet Tazeb Wondie 4 , Temesgen Birlie Asmare 5 , Degalem Tilahun Worku https://orcid.org/0000-0002-0979-5052 2 , Abere Gebru Abuhay 6 , Mohammed Tessema Gebeyehu 7 , Astewil Moges Bazezew https://orcid.org/0009-0000-6472-6378 8 , Mulugeta Endalamaw Ayenew 2 Gezahagn Demsu Gedefaw https://orcid.org/0009-0003-3584-4545 1 , Geta Bayu Genet https://orcid.org/0009-0001-3697-841X 2 , [...] Asnake Tadesse Abate https://orcid.org/0009-0005-4669-3206 3 , Wubet Tazeb Wondie 4 , Temesgen Birlie Asmare 5 , Degalem Tilahun Worku https://orcid.org/0000-0002-0979-5052 2 , Abere Gebru Abuhay 6 , Mohammed Tessema Gebeyehu 7 , Astewil Moges Bazezew https://orcid.org/0009-0000-6472-6378 8 , Mulugeta Endalamaw Ayenew 2 PUBLISHED 06 Jun 2025 Author details Author details 1 Department of Neonatal Health Nursing, School of Nursing, University of Gondar College of Medicine and Health Sciences, Gondar, Amhara, Ethiopia 2 Department of Pediatrics and Child Health School of Medicine, University of Gondar College of Medicine and Health Sciences, Gondar, Amhara, Ethiopia 3 School of Nursing and Midwifery, Department of Pediatrics and Child Health Nursing, Haramaya University College of Health and Medical Sciences, Dire Dawa, Dire Dawa, Ethiopia 4 Department of Pediatrics and Child Health Nursing, College of Medicine and Health Sciences and Referral Hospital, Ambo University, Ambo, Ethiopia 5 Department of Anesthesia, Debre Tabor University, Debre Tabor, Amhara, Ethiopia 6 Department of Pediatrics and Child Health Nursing, Debre Tabor University, Debre Tabor, Amhara, Ethiopia 7 Department of Pediatrics and Child Health Nursing, Debre Berhan University, Debre Birhan, Amhara, Ethiopia 8 Department of Surgical Nursing, School of Nursing, University of Gondar College of Medicine and Health Sciences, Gondar, Amhara, Ethiopia Gezahagn Demsu Gedefaw Roles: Conceptualization, Data Curation, Formal Analysis, Funding Acquisition, Investigation, Methodology, Project Administration, Resources, Software, Supervision, Validation, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing Geta Bayu Genet Roles: Formal Analysis, Funding Acquisition, Investigation, Writing – Original Draft Preparation Asnake Tadesse Abate Roles: Investigation, Software, Supervision, Visualization, Writing – Original Draft Preparation Wubet Tazeb Wondie Roles: Conceptualization, Data Curation, Methodology, Project Administration, Writing – Review & Editing Temesgen Birlie Asmare Roles: Methodology, Resources, Software, Supervision, Validation, Visualization, Writing – Original Draft Preparation Degalem Tilahun Worku Roles: Conceptualization, Data Curation, Resources, Software, Supervision, Writing – Original Draft Preparation Abere Gebru Abuhay Roles: Formal Analysis, Funding Acquisition, Investigation, Resources, Software, Writing – Review & Editing Mohammed Tessema Gebeyehu Roles: Methodology, Project Administration, Resources, Software, Supervision, Writing – Original Draft Preparation Astewil Moges Bazezew Roles: Conceptualization, Methodology, Validation, Visualization, Writing – Original Draft Preparation Mulugeta Endalamaw Ayenew Roles: Conceptualization, Data Curation, Formal Analysis, Funding Acquisition, Investigation, Methodology, Project Administration, Resources, Software, Supervision, Validation, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing OPEN PEER REVIEW REVIEWER STATUS AWAITING PEER REVIEW This article is included in the Global Public Health gateway. Abstract Introduction phlebitis is one of the complications associated with the placement of peripheral intravascular lines in neonates and serves as an indicator of the quality of care provided by health professionals. Determining its incidence and predictors provides valuable evidence for stakeholders to address this issue and the potential factors contributing to phlebitis. Objective This study aims to determine the incidence and predictors of phlebitis among neonates with perinatal asphyxia admitted at the neonatal intensive care unit of West Amhara Comprehensive Specialized Hospital, Northwest Ethiopia, 2023. Method A multicentered, institution-based prospective follow-up study was conducted from May 1 to August 30, 2024, at the Northwest Amhara Region Comprehensive Specialized Hospital in Northwest Ethiopia. A systematic random sampling technique was employed, and data were collected using a data extraction checklist from the medical registry of neonates. The collected data were entered into EPI-DATA V.4.6.0.0 and analyzed using STATA V.14. The Kaplan-Meier failure curve and log-rank test were utilized, and both bivariable and multivariable Cox regression analyses were performed to identify predictors of phlebitis. Statistical significance was defined as p ≤ 0.05. Result The overall incidence of phlebitis was 20.9 per 1,000 neonate-day observations (95% CI: 17.12-25.54) during the entire follow-up period. Of the 423 neonates admitted to the NICU, 96 (22.69%) (95% CI: 18.93-26.94) developed phlebitis. Significant predictors included birth asphyxia (AHR= 2.1; 95% CI: 1.38-3.19), trials of cannulation (AHR=2.5; 95% CI: 1.01-6.36), macrosomic neonates (AHR=3.05; 95% CI: 1.17-7.96), flushed cannulas (AHR=0.54; 95% CI: 0.31-0.97), and short dwelling time (AHR=0.47; 95% CI: 0.29-0.765). Conculsion The incidence rate of phlebitis was higher than that reported in other studies. Predictors of phlebitis included birth asphyxia, the number of cannulation trials, macrosomic neonates, flushed cannulas, and shorter dwelling times. READ ALL READ LESS Keywords Phelibites, Incidence, Predictors, Neonates, Neonatal intensive care unit Corresponding Author(s) Gezahagn Demsu Gedefaw ( [email protected] ) Close Corresponding author: Gezahagn Demsu Gedefaw Competing interests: No competing interests were disclosed. Grant information: The author(s) declared that no grants were involved in supporting this work. Copyright: © 2025 Demsu Gedefaw G et al . This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. How to cite: Demsu Gedefaw G, Genet GB, Abate AT et al. Incidence And Predictors Of Phlebites In Neonates Admitted To Nicus In Northwest Amhara Comprehensive Specialized Hospitals, Northwest Ethiopia, 2023:Multi Center Study [version 1; peer review: awaiting peer review] . F1000Research 2025, 14 :563 ( https://doi.org/10.12688/f1000research.164575.1 ) First published: 06 Jun 2025, 14 :563 ( https://doi.org/10.12688/f1000research.164575.1 ) Latest published: 06 Jun 2025, 14 :563 ( https://doi.org/10.12688/f1000research.164575.1 ) Introduction Neonates admitted to hospitals require vascular access for various purposes, such as fluid or drug administration, blood transfusion, and diagnostic procedures. The insertion of a peripheral intravascular line is essential for the care of neonates in the neonatal intensive care unit (NICU) and is one of the most common invasive procedures. 1 , 2 Phlebitis is a complication of peripheral intravascular line placement in neonates and serves as a measure of the quality of healthcare provided. 3 Rates of phlebitis occurrence are high in different studies ranging from 5% to 18%. 4 – 6 Phlebitis-related pericardial effusion is a fatal complication that can lead to high mortality if not diagnosed and treated promptly. However, atypical manifestations and rapid deterioration pose challenges for neonatologists, and there has been limited global investigation reported to date. 7 The development of phlebitis in the NICU prolongs patients’ hospital stays, leads to unnecessary diagnostic procedures and treatments, increases stress for families, raises the workload for healthcare providers, and imposes high costs and economic burdens on families, society, and healthcare systems. 8 To address this issue and improve neonatal survival, the World Health Organization (WHO) is collaborating with the Ministry of Health and other partners to enhance the quality of services for neonates by strengthening neonatal care and maternal obstetric health programs. 9 Despite phlebitis being common, there is often an assumption that it will resolve spontaneously. However, if not identified early and treated effectively, it can lead to complications such as thrombophlebitis, deep vein thrombosis, septicemia, or endocarditis. 10 Despite this, there is limited information on the incidence and predictors of phlebitis in the Amhara regional state of Ethiopia. Therefore, determining its incidence and predictors provides valuable evidence for stakeholders to address the issue and identify potential contributing factors. Methods Study design period and Study area An Multi-center institution-based prospective follow-up study was conducted from May 1 to August 30, 2024, at the Northwest Amhara Region Comprehensive Specialized Hospital in Northwest Ethiopia. In the Amhara region, there are seven level III neonatal intensive care units, according to WHO standards, however in northwest Amhara region five comprehensive specialized hospitals. Out of five comprehensive specialized hospitals (CSHs), three were selected using a random sampling technique: UoG CSH, Tibebe Ghion CSH, and Debre Tabor CSH. These selected hospitals admit approximately 6,912, 2,712, and 2,424 neonates annually, respectively, of whom some require specialized care. A team of pediatricians, general practitioners, neonatal nurses, and other personnel works in these institutions. They collaborate to assess, diagnose, and provide comprehensive, holistic care for these vulnerable neonates. The neonatal intensive care units offer primary services for neonates with perinatal asphyxia, including general neonatal care such as antibiotic treatment, phototherapy, blood transfusions, exchange transfusions, and ventilatory support like Continuous Positive Airway Pressure (CPAP), along with different medications. Population of the study Source population and study population All neonates admitted to the NICU at selected comprehensive specialized hospitals in the northwest Amhara Region constituted the source population. The study population included all neonates admitted to the NICU of these hospitals from May 1 to August 30, 2024. Inclusion and exclusion criteria All neonates admitted to the NICU of selected comprehensive specialized hospitals in Northwest Amhara during the study period were included. Neonates with known skin infections, those admitted for less than 24 hours, and those who developed complications before arriving at the study settings were excluded. Sample size determination For the first objective, the minimum required sample size is calculated using the single population proportion formula. This calculation incorporates the following statistical assumptions: P = proportion of phlebitis (50%), α /2 = the corresponding Z score for a 95% confidence interval, and (d) the margin of error (5%). n = ( za 2 ) 2 ∗ ( p ∗ ( 1 − p ) ) d 2 n = ( 1.96 ) 2 ∗ ( 0.5 ( 1 − 0.5 ) ) ( 0.05 ) 2 = 384 After adding a 10% contingency for incomplete charts, the sample size was 423. Sampling technique and procedure A proportional allocation of the sample size was conducted for each selected comprehensive specialized hospital in the northwest Amhara region, based on monthly admissions derived from annual data. Specifically, UoGCSH had an average of 345 admissions per month, while TGCSH had 250. Over a four-month period, these hospitals admitted a total of 2,380 neonates. A total of 423 neonates were selected using a systematic sampling technique ( Figure 1 ). Figure 1. Schematic presentation of sampling procedure to assess the incidence of phlebitis and its predictors among neonates admitted at NICU Northwest Amhara Comprehensive Specialized Hospitals from May 1, to August 30, 2024. Variables of the study Dependent variable Incidence of phlebitis Event/censored Independent variables Neonatal socio-demographic variables include sex, weight, age, and gestational age. Intravenous cannula-related factors encompass antibiotics, type of fluid flushing, blood transfusion, experience in NICU, and duration of neonatal age. Additionally, neonatal comorbidities include sepsis, meningitis, birth asphyxia, respiratory distress syndrome (RDS), congenital heart disease, hypoglycemia, and necrotizing enterocolitis (NEC). Operational definitions Neonates who were referred for treatment against their will, experiencing disappearance, death, or discharge with a good outcome during the study period. Follow-up time : The time admission from the NICU until either an event or censorship occurs at 28 days. Phlebitis: According to Jackson’s visual infusion phlebitis scoring was defined as the presence of two or more signs of induration, fever, erythema, swelling, or a palpable cord with or without purulent drainage from the catheter insertion site. 11 Score 1 - Slight pain or slight redness near IV insertion site. These are possible early signs of phlebitis . Score 2 - Two of the following signs are evident: pain at IV site, redness or swelling medium stage of phlebitis called early stage of phlebitis . Score 3 - All of the following signs are evident: pain along the path of the cannula, redness around the insertion site and swelling called medium stage of phlebitis . Score 4 - All of the following signs are evident and extensive: pain along the path of the cannula, redness around the insertion site, swelling, palpable venous cord so called advanced stage of phlebitis or at the start of thrombophlebitis . Score 5 - All of the following signs are evident and extensive: pain along the path of the cannula, redness around the insertion site, swelling, palpable venous cord, pyrexia called the stage of advanced thrombophlebitis. 11 Data collection tool and procedures The data collection tool was adapted by reviewing relevant literature related to the problem under study, ensuring that all possible variables addressing the study’s objectives were incorporated. The tool consists of five parts: Part One focuses on socio-demographic characteristics, Part Two addresses neonatal comorbidities, Part Three covers cannulation, Part Four examines neonatal outcome status, and Part Five includes the Amharic version of the maternal sociodemographic sections. Data were prospectively collected by two experienced general practitioners under the supervision of two MSc neonatal nurses, who hold bachelor’s degrees and have been working in the neonatal intensive care unit. Data quality control The data collection tool was adapted by reviewing relevant literature and drawing from validated standards, such as the Ethiopian Demographic and Health Survey checklists. Initially prepared in English, it was then translated into Amharic. To ensure consistency and clarity, language experts and health professionals retranslated it back into English. For clinical variables, an English version of the chart review checklists was developed. Before data collection commenced, the tool was evaluated and critiqued by research experts to assess its validity. After obtaining written informed consent from the mothers, data were collected through interviews and by reviewing the medical records of the neonates. The data collection process involved three supervisors and data collectors. Additionally, a 5% pretest was conducted at the Gondar Comprehensive Specialized Hospital to validate the instrument or questionnaire prior to the actual data collection. Data processing and analysis The data were cleaned for inconsistencies and missing values, with necessary amendments considered before analysis. The cleaned data were then entered into Epi-data 4.6.0.2 software and subsequently exported to STATA 14 statistical software. Descriptive statistics, including mean with standard deviation, median with interquartile range, frequency, and percentages, were computed based on the nature of the variables. Each participant’s outcome was dichotomized into censored and event categories. The incidence density rate was calculated for the entire study period. Kaplan-Meier methods were employed to estimate the median failure time and cumulative probability of failure, with the KM plot and log-rank tests used to compare failure function curves between groups. Before performing Cox proportional hazard regression, model goodness-of-fit was assessed using the Schoenfeld residual test and Cox-Snell residuals, while multicollinearity was evaluated using variance inflation factors. Bivariable Cox proportional hazard regression was conducted for each predictor variable, including those with p-values <0.2 in the multivariable analysis. Adjusted hazard ratios with 95% confidence intervals and p-values <0.05 were utilized to determine statistical significance. Finally, the results were presented through text, graphs, figures, and tables. Result A total of 423 neonate-mother pairs were included in the study, achieving a 100% response rate for meeting the inclusion criteria. Approximately three-fourths of the mothers (290) were in the 21-34 age group, with a mean age of 29.61 ± 6.27 years. Of the total enrolled mothers, more than 221 (52.25%) lived in rural areas ( Table 1 ). Table 1. Socio-demographics of mothers in the NICU in Northwest Amhara comprehensive specialized hospitals in Northwest Ethiopia, Ethiopia, 2024. Variables Category Percent Status Event Censored Age of mother 35 102 (24.11) 28 (27.45) 74 (72.55) Residency Rural 221 (52.25) 37 (23.08) 147 (76.92) Urban 202 (47.75) 45 (22.28) 157 (77.72) Educational status Unable to read and write 36 (8.51) 11 (30.56) 25 (69.44) Primary 129 (30.50) 19 (14.73) 110 (85.27) Secondary 111 (26.24) 28 (25.23) 83 (74.77) College and above 147 (34.75) 25.85 (38) 74.15 (109) Occupation House wife 37 (8.75) 63 (16.22) 233 (83.78) Merchant 55 (13.00) 27 (25.45) 89 (74.55) Civil servant 165 (39.01) 6 (26.06) 5 (73.94) Daily labour 166 (39.24) 33 (19.88) 133 (80.12) Marital status Single 93 (21.99) 21 (22.58) 72 (77.42) Married 182 241 330 (78.01) 75 (22.73) 255 (77.27) Neonatal comorbidities sociodemography and Neonatal comorbidities In this study, the vast majority of neonates (88.18%) were admitted to the hospital for less than three days. More than half of the neonates (53.66%) were born at term, with a median weight of 2900 g (IQR 850). Additionally, over two-thirds of the newborns (69.27%) were appropriate for their gestational age. Notably, almost half of the neonates (78.01%) developed sepsis, while 26.95% developed meningitis, and 28.13% experienced birth asphyxia ( Table 2 ). Table 2. Socio-demographic and Neonatal comorbidities of Neonates in the NICU of Northwest Amhara comprehensive specialized hospitals in Northwest Ethiopia, Ethiopia, 2024. Variables Category Percent Status Event Censored Age of the neonate 7 7 (1.65) 2 (28.57) 5 (71.43) Sex Male 184 (43.50) 37 (20.11) 147 (79.89) Female 239 (56.50) 59 (24.69) 180 (75.31) GA Term 227 (53.66) 159 (70.04) 68 (29.96) Preterm 173 (40.90) 114 (65.90) 59 (34.10) Post-term 23 (5.44) 18 (78.26) 5 (21.74) Birth weight NBW 296 (69.98) 63 (21.28) 233 (78.72) LBW 116 (27.42) 27 (23.28) 89 (76.72) Macrocosmic 11 (2.60) 6 (54.55) 5 (45.45) Weight for age AGA 293 (69.27) 66 (22.53) 227 (77.47) SGA 56 (13.24) 15 (26.79) 41 (73.21) LGA 74 (17.49) 15 (20.27) 59 (79.73) Sepsis Yes 330 (78.01) 79 (23.94) 251 (76.06) No 182 241 16 (18.28) 76 (81.72) 79 (32.78) Birth asphyxia Yes 119 (28.13) 53 (44.54) 66 (55.46) No 304 (71.87) 43 (14.14) 261 (85.86) Meningitis Yes 114 (26.95) 25 (21.93) 89 (78.07) No 309 (73.05) 71 (22.98) 238 (77.02) RDS Yes 54 (12.77) 12 (22.22) 42 (77.78) No 369 (87.23) 84 (22.76) 285 (77.24) CHD Yes 30 (7.0) 4 (13.33) 26 (86.67) No 393 (92.91) 92 (23.41) 351 (76.59) NEC Yes 74 (17.49) 14 (18.92) 74 (81.08) No 349 (82.51) 82 (23.50) 267 (76.50) Cannulations characteristics Most of the peripheral intravenous cannulas were inserted in the anterior cubital fossa of the neonates’ hands. This accounted for 197 (46.57%) of the cannulas and represented approximately two-thirds of the neonates, totaling 241 (52.16%) who received maintenance D10 and N/S. During the study period, 121 (28.61%) patients were flushed before receiving medication. Half of the neonates, 227 (53.66%), had dwelling times of less than four days. Among the neonates, one-fourth, or 110 (26.00%), had their peripheral intravenous cannula inserted by a nurse with less than six months of experience ( Table 3 ). Table 3. Neonatal cannulation in the NICU of Northwest Amhara comprehensive specialized hospitals in Northwest Ethiopia, Ethiopia, 2024. Covariates Category Total Number (%) Status Event Censored Function of cannulation Rehydration 54 (12.77) 9 (16.67) 45 (83.33) Maintenance D10 and N/S 276 (65.25) 60 (21.74) 216 (78.26) Blood transfusion 93 (21.99) 27 (29.03) 67 (70.97) Flushing Yes 121 (28.61) 19 (15.70) 102 (84.30) No 182 241 302 (71.39) 77 (25.50) 225 (74.50) Experience of nurse 6 months 313 (74.00) 69 (22.04) 244 (77.96) Place of insertion Scalp 51 (12.06) 9 (22.34) 42 (77.66) Anterior cubital fossa 197 (46.57) 44 (23.41) 153 (76.59) Forearm 175 (41.37) 43 (24.57) 132 (75.43) Time of therapy Intermittent 379 17 258 (60.99) 60 (23.26) 198 (76.74) Continuous 165 (39.01) 36 (21.82) 129 (78.18) Dwelling 4 days 196 (46.34) 70 (35.71) 126 (64.29) Cannulation trial One times 41 (9.69) 5 (12.20) 36 (87.80) Two times 188 (44.44) 20 (10.64) 168I (89.36) Three times 194 (45.86) 71 (36.60) 123 (63.40) Proportional Hazard Assumption (PHA) test The PHA was assessed using the Schoenfeld residuals test. The results indicated that the p value for each covariate, as well as for all covariates together, was above 0.05 (p = 0.2322). Incidence of phlebitis and overall outcome of the follow-up In this study, we followed the neonates for a maximum of 17 days from the date of admission. Throughout the follow-up period, we made a total of 4,590 observations of neonate days. This number was obtained by adding the amount of time each neonate was followed during the study, measured in days. The overall incidence of phlebitis was 20.9 per 1,000 neonate-day observations (95% CI: 17.12-25.54) during the entire follow-up period. Of the 423 neonates admitted to the NICU, 96 (22.69%) (95% CI: 18.93-26.94) developed the event of interest, phlebitis. Score of phlebitis Out of a total of 96 neonates, 22.69% showed early signs of phlebitis. The distribution of scores is as follows: early signs of phlebitis - 15 (15.62%), early stage of phlebitis - 24 (25%), medium stage of phlebitis - 23 (23.96%), advanced stage of phlebitis or the start of thrombophlebitis - 21 (21.88%), and advanced thrombophlebitis - 13 (13.54%) ( Figure 2 ). Figure 2. Overall neonatal phlebitis score among neonates admitted to comprehensive and specialized hospitals in the NICU of Northwest Amhara, Ethiopia, 2024. Overall failure function (survivorship function) The Kaplan-Meier failure function indicated that the likelihood of developing phlebitis increased with longer follow-up times ( Figure 3 ). Figure 3. The overall Kaplan–Meier failure estimate curve, with a 95% confidence interval, shows the time to develop neonatal phlebitis at Northwest Ethiopia Comprehensive Specialized Hospital from May 1 to August 30, 2024 (n = 423). The goodness of fit test The goodness of fit for the fitted model was checked using the Cox-Snell residual test. As shown in the figure, the Cox-Snell regression model was adequate ( Figure 4 ). Figure 4. The Cox-Snell residual test of Cox regression for the incidence of phlebitis. Bi-variable and multi-variable cox regression analysis In the bivariable Cox regression analysis, several variables were found to be associated with phlebitis (p < 0.25), including birth asphyxia, flushing of the cannula before medication, dwelling, trial of cannulation, birth weight, educational status, congenital heart disease, and sepsis. However, in the multivariable Cox regression analysis, only five variables remained as significant predictors of phlebitis (p < 0.05). Specifically, neonates with birth asphyxia had a 2.1 times higher hazard of developing phlebitis compared to those without birth asphyxia (Adjusted Hazard Ratio [AHR] 2.1; 95% Confidence Interval [CI] 1.38–3.19). Neonates who underwent three trials of cannulation had a 2.5 times higher hazard of developing phlebitis compared to those who underwent one or two trials (AHR 2.5; 95% CI 1.01–6.36). Additionally, neonates with birth weights of 4000 g or greater had a three times higher hazard of developing phlebitis compared to those with low and normal birth weights (AHR 3.05; 95% CI 1.17–7.96). On the other hand, neonates who had their cannula flushed were 54% less likely to develop phlebitis compared to their counterparts (Adjusted Hazard Ratio [AHR] 0.54; 95% Confidence Interval [CI] 0.31–0.97). Similarly, neonates who had cannulas in place for less than 4 days had a 47% lower likelihood of developing phlebitis compared to those who dwelled longer (AHR 0.47; 95% CI 0.29–0.765) ( Table 4 ). Table 4. Bivariable and multivariable cox regression analyses were conducted to identify predictors of phlebitis among neonates in comprehensive specialized hospitals in Northwest Ethiopia from May 1 to August 30, 2024 (n = 423). Variables CHR (95%CI) p-value AHR (95%CI) P-value Educational status Unable to read and write 11.45 (0.74-2.86) 0.28 1.01 (0.54-2.26) 0.794 Primary 1.45 (0.74-2.86) 0.29 0.82 (0.46-1.45) 0.510 Secondary 1.43 (0.87-2.36) 0.158 1.22 (0.67-2.14) 0483 Collage and above 1 1 Sepsis Yes 1.44 (0.85-2.43) 0.176 1.03 (0.57-1.86) 0.908 No 1 1 Birth asphyxia Yes 2.5 (1.65-3.71) 0.000 2.1 (1.38-3.19) 0.001 No 1 1 CHD Yes 0.51 (0.19-1.39) 0.191 0.50 (0.17-1.45) 0.206 No 1 1 Flushing Yes 0.64 (.393-1.06) 0.085 0.54 (0.31-0.970) 0.039 No 1 1 Dwelling 4 days 1 1 Cannulation One times 1 1 1 1 Two times 1.00 (0.38-2.69) 0.990 0.95 (0.35-2.56) 0.923 Three times 3.24 (1.3-8.06) 0.000 2.5 (1.01-6.36) 0.048 Birth weight NBW 1 1 1 1 LBW 0.94 (.59-1.48) 0.801 1.01 (0.63-1.65) 0.945 Macrocosmic 2.39 (.98-5.86) 0.055 3.05 (1.17-7.96) 0.023 Discussion This study aimed to assess the incidence of phlebitis and its predictors among neonates admitted to comprehensive specialized hospitals in Northwest Ethiopia. The overall incidence of phlebitis was 20.9 per 1,000 neonate-day observations (95% CI: 17.12-25.54) during the entire follow-up period. Out of 423 neonates admitted to the NICU, 96 (22.69%) (95% CI: 18.93-26.94) developed the event of interest, phlebitis. The result of this study indicate a lower incedance of phlibitis findings from study conducted in Jordan 12 in China. 13 The discrpenacy may be attributed to differences in patient populations, clinical practices, staffing levels, available resources, and methods of measuring outcomes. Additionally, the smaller sample size may limit the generalizability of the results. Variation in adherence of clinical guidelines and protocls across different ICUs could also contributed to the observed difference in the treatment approaches. 14 , 15 On the other hand, the incedance reported in this study is higher than that found in studies from India, 16 spain, 17 and China. 18 This could be explained by the generally shorter length of stay in pediatric wards, where patients typically exahibit better level of concuesness and lower pain severity. Factors such as the complaity of care, patient acuity, and the management of intravenous lines may lead to higher incidence rates in neonatal intensive care units compared to the pediatric settings. 16 Farthermore, the limited acess to data and insufficient clarity in secondary data may obscure accurate diagnosis in patient charts potentially influencing the reported incidence rate. 19 The overall incidence of phlebitis in this study was 20.9 per 1,000 neonate-day observations (95% CI: 17.12-25.54). This rate underscores the need for vigilance in managing intravenous therapy within neonatal care units. Compared to existing literature, which reports varying phlebitis rates among neonates, our findings indicate that there is room for improvement in clinical practices. Factors such as the types of intravenous access devices used, dwelling time, the number of cannulation attempts, and the duration of catheterization may contribute to this incidence, highlighting the importance of adhering to best practices in IV management. To reduce the risk of phlebitis, targeted interventions such as enhanced training for healthcare providers and implementing standardized protocols could be beneficial. Additionally, further research is needed to explore the effectiveness of these strategies in lowering phlebitis rates and improving neonatal outcomes. The hazard of developing phlebitis was 2.1 times higher among neonates with birth asphyxia as compared to those without birth asphyxia. This finding was notsupported by a studies, however Aggressive fluid resuscitation and medication administration often require prolonged IV access, which can compromise circulation and vascular integrity, making veins more susceptible to irritation and injury. Neonates may need extended durations of IV therapy, increasing the likelihood of phlebitis due to prolonged catheter placement. Asphyxia can lead to neurological issues that result in increased movement or seizures, potentially causing catheter displacement and irritation. Additionally, asphyxia may compromise the immune system, raising the risk of infection, which can also contribute to phlebitis. 20 Neonates who underwent three trials of cannulation had a 2.5 times higher hazard of developing phlebitis compared to those who underwent one or two trials. This finding was supported by a study conducted in Australia 5 in Canada. 21 the possible justification to Multiple attempts at cannulation may increase the risks of vascular irritation and subsequent complications. Therefore, it is important to focus on effective cannulation techniques and minimize the number of attempts. This approach will help reduce the incidence of phlebitis in vulnerable neonate populations. 5 , 21 Neonates with birth weights greater than or equal to 4000 g had a three times higher hazard of developing phlebitis compared to neonates with low birth weight and normal birth weight. The need for deeper or less significant venous access can result in more traumatic insertions. Macrosomic neonates often require increased fluid administration compared to normal and low birth weight, which can extend the duration of IV therapy and heighten the risk of irritation at the insertion site. Additionally, the subcutaneous tissue in larger neonates tends to be thicker, making proper catheter insertion more challenging and potentially leading to irritation. Furthermore, larger neonates are likely to be more active, which can contribute to catheter displacement and irritation at the insertion site. Neonates who had their cannula flushed were found to be 54% less likely to develop phlebitis compared to those who did not. This finding was supported by a study conducted in iran. 22 The rational behind this is that regular flusing of the IV line before and after medication helps prevent truma to the vessel and keeps the line clear. By maintaining an open IV line, flushing reduce the risk of blockage that increases pressure irritate the vein. It also helps dilute and eliminate any residual medications or irritants that might lead to inflammation. Furthermore, consistant flushe decreases the likelyhood of clot formation within the cannula, which is contributing factor to the development of phlibitis. Neonates with a cannula duration of less than 4 days were found to have a 47% lower liklihood of developing phlibitis compared to those cannulas remained in place for more than 4 days. This finding is supported by studies conducted in Ethiopia. 23 – 25 The underline reson for this may be that minimizing the duration of cannula use helps prevent prolonged irritation of a single vein. 24 , 25 Shorter dwelling time contribute to a safer and more comfortable experience for neonates by reducing exposure to irritant medications and infusions, as well as lowering the risk of colonization and subsequent infections. Strength and limitation This study is among the first to specifically examine phlebitis in neonates, addressing a significant gap in the existing literature. It does not explore a multidisciplinary approach to care that includes pharmacists and infection control specialists for optimizing IV therapy management. Additionally, it only assesses the vein viewer. However, it does not consider its availability in both hospitals or the newer catheter designs and materials that are less likely to irritate veins, such as those with smoother surfaces or biocompatible coatings. Conclusion and recommendation The incidence rate of phlebitis was higher than in other studies. Predictors of phlebitis included birth asphyxia, trials of cannulation, macrosomic neonates, flushed cannulas, and short dwelling time. Protocols for regular site assessment, timely catheter changes, and ongoing education for healthcare providers on proper IV insertion techniques especially for nurses with less than six months of experience are essential. A system for regular monitoring of IV sites and documentation of complications, including phlebitis, should be established. Stakeholders should focus on these predictors and implement appropriate interventions. Ethical declarations Ethics approval and consent to participate Ethical clearance was obtained from the University of Gondar collage of medicine and health science Specialized hospital institutional research ethics review committee ( IRERC)/35/17/2024 of the Collage of Medicine and Health science Specialized Referral Hospital ( CMHSSH ). The letter of permission was obtained from the North West Gondar Public Hospital medical director’s office. Finally, both written and verbal informed consent was obtained from the mothers after explaining all the purposes, benefits, confidentiality of the information, and the voluntary nature of participation in the study before the data collection. All methods were carried out in accordance with the declarations of Helsinki and relevant guidelines and regulations. The names and/or identification numbers of the study participants were not recorded on the data collection tool. All data were kept strictly confidential and used only for this study’s purposes. Availability of data and material Underlying data Figshare: Incidence and predictors of phlibites in neonates admitted to Nicus In Northwest Amhara comprehensive specialized hospitals, Northwest Ethiopia, 2023: Multi Center Study https://doi.org/10.6084/m9.figshare.28715378.v1 . 26 This project contains the following underlying data: Phlibitis Excel.xls Data are available under the terms of the CC BY 4.0 license Extended data 1. Figshare: ethical clearance, https://doi.org/10.6084/m9.figshare.28855733.v1 27 Data are available under the terms of the CC BY 4.0 license 2. Figshare: Gedefaw, Gezahagn (2025). STROBE_checklist_phlibities_combined.doc. figshare. Journal contribution. https://doi.org/10.6084/m9.figshare.28715732.v1 28 Data are available under the terms of the CC BY 4.0 license 3. Figshare questionnaire: https://doi.org/10.6084/m9.figshare.29097527.v1 29 (Gedefaw, 2025 #80) Data are available under the terms of the CC BY 4.0 license 4. Figshare Consent: https://doi.org/10.6084/m9.figshare.29097437.v2 30 Data are available under the terms of the CC BY 4.0 license Acknowledgment We would like to acknowledge and express our sincere gratitude to our colleagues for their invaluable comments, suggestions, and support regarding the proposal, as well as for providing the necessary materials to write it. Additionally, we thank the University of Gondar Institutional Review Board for reviewing this thesis. References 1. Bahrami N, Tork-Torabi M, Namnabati M, et al. : Predisposing factors of phlebitis in children treated with vancomycin. Sci. J. Kurdistan Univ. Med. Sci. 2021; 26 (2): 64–78. Publisher Full Text 2. Baik-Schneditz N, Pichler G, Schwaberger B, et al. : Peripheral intravenous access in preterm neonates during postnatal stabilization: feasibility and safety. 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Comments on this article Comments (0) Version 1 VERSION 1 PUBLISHED 06 Jun 2025 ADD YOUR COMMENT Comment Author details Author details 1 Department of Neonatal Health Nursing, School of Nursing, University of Gondar College of Medicine and Health Sciences, Gondar, Amhara, Ethiopia 2 Department of Pediatrics and Child Health School of Medicine, University of Gondar College of Medicine and Health Sciences, Gondar, Amhara, Ethiopia 3 School of Nursing and Midwifery, Department of Pediatrics and Child Health Nursing, Haramaya University College of Health and Medical Sciences, Dire Dawa, Dire Dawa, Ethiopia 4 Department of Pediatrics and Child Health Nursing, College of Medicine and Health Sciences and Referral Hospital, Ambo University, Ambo, Ethiopia 5 Department of Anesthesia, Debre Tabor University, Debre Tabor, Amhara, Ethiopia 6 Department of Pediatrics and Child Health Nursing, Debre Tabor University, Debre Tabor, Amhara, Ethiopia 7 Department of Pediatrics and Child Health Nursing, Debre Berhan University, Debre Birhan, Amhara, Ethiopia 8 Department of Surgical Nursing, School of Nursing, University of Gondar College of Medicine and Health Sciences, Gondar, Amhara, Ethiopia Gezahagn Demsu Gedefaw Roles: Conceptualization, Data Curation, Formal Analysis, Funding Acquisition, Investigation, Methodology, Project Administration, Resources, Software, Supervision, Validation, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing Geta Bayu Genet Roles: Formal Analysis, Funding Acquisition, Investigation, Writing – Original Draft Preparation Asnake Tadesse Abate Roles: Investigation, Software, Supervision, Visualization, Writing – Original Draft Preparation Wubet Tazeb Wondie Roles: Conceptualization, Data Curation, Methodology, Project Administration, Writing – Review & Editing Temesgen Birlie Asmare Roles: Methodology, Resources, Software, Supervision, Validation, Visualization, Writing – Original Draft Preparation Degalem Tilahun Worku Roles: Conceptualization, Data Curation, Resources, Software, Supervision, Writing – Original Draft Preparation Abere Gebru Abuhay Roles: Formal Analysis, Funding Acquisition, Investigation, Resources, Software, Writing – Review & Editing Mohammed Tessema Gebeyehu Roles: Methodology, Project Administration, Resources, Software, Supervision, Writing – Original Draft Preparation Astewil Moges Bazezew Roles: Conceptualization, Methodology, Validation, Visualization, Writing – Original Draft Preparation Mulugeta Endalamaw Ayenew Roles: Conceptualization, Data Curation, Formal Analysis, Funding Acquisition, Investigation, Methodology, Project Administration, Resources, Software, Supervision, Validation, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing Competing interests No competing interests were disclosed. Grant information The author(s) declared that no grants were involved in supporting this work. Article Versions (1) version 1 Published: 06 Jun 2025, 14:563 https://doi.org/10.12688/f1000research.164575.1 Copyright © 2025 Demsu Gedefaw G et al . This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Download Export To Sciwheel Bibtex EndNote ProCite Ref. Manager (RIS) Sente metrics Views Downloads F1000Research - - PubMed Central info_outline Data from PMC are received and updated monthly. - - Citations open_in_new 0 open_in_new 0 open_in_new SEE MORE DETAILS CITE how to cite this article Demsu Gedefaw G, Genet GB, Abate AT et al. Incidence And Predictors Of Phlebites In Neonates Admitted To Nicus In Northwest Amhara Comprehensive Specialized Hospitals, Northwest Ethiopia, 2023:Multi Center Study [version 1; peer review: awaiting peer review] . F1000Research 2025, 14 :563 ( https://doi.org/10.12688/f1000research.164575.1 ) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS track receive updates on this article Track an article to receive email alerts on any updates to this article. TRACK THIS ARTICLE Share Open Peer Review Current Reviewer Status: AWAITING PEER REVIEW AWAITING PEER REVIEW ? 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Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Comments on this article Comments (0) Version 1 VERSION 1 PUBLISHED 06 Jun 2025 ADD YOUR COMMENT Comment keyboard_arrow_left keyboard_arrow_right Open Peer Review Reviewer Status AWAITING PEER REVIEW Comments on this article All Comments (0) Add a comment Sign up for content alerts Sign Up You are now signed up to receive this alert Browse by related subjects Alongside their report, reviewers assign a status to the article: Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. 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