A pragmatic stepped wedge cluster randomised implementation trial assessing the effect of a quality improvement programme on the proportion of infants achieving delayed cord clamping for more than 60 seconds in infants <37 weeks gestation: Statistical analysis plan for the Wait a Minute or More (WAMM) trial | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF update A pragmatic stepped wedge cluster randomised implementation trial assessing the effect of a quality improvement programme on the proportion of infants achieving delayed cord clamping for more than 60 seconds in infants <37 weeks gestation: Statistical analysis plan for the Wait a Minute or More (WAMM) trial Kristy P Robledo, Himanshu Popat, Isabel Li, Sarah Finlayson, and 12 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-8876192/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract The Wait a Minute or More (WAMM) trial is a pragmatic stepped-wedge cluster randomised implementation trial designed to increase the proportion of preterm infants receiving delayed cord clamping for at least 60 seconds (DCC60) across Australian maternity hospitals. This statistical analysis plan prespecifies primary, secondary, and exploratory analyses prior to accessing outcome data. The primary analysis will use mixed-effects modelling to estimate the effect of a locally adapted quality improvement programme and accurate data sharing, on achieving DCC60, accounting for clustering and secular trends. By detailing our approach, this SAP ensures transparency, reproducibility, and rigorous evaluation of the WAMM intervention. stepped wedge cluster randomised trial neonatal statistical analysis plan Full Text Additional Declarations No competing interests reported. Supplementary Files WAMMSAPSupplementary20260210.docx Cite Share Download PDF Status: Posted Version 1 posted 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. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. 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-8876192","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"update","associatedPublications":[],"authors":[{"id":596301192,"identity":"bf9021e7-1d7c-47c2-8dc7-635ca91bf593","order_by":0,"name":"Kristy P Robledo","email":"data:image/png;base64,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","orcid":"","institution":"The University of Sydney","correspondingAuthor":true,"prefix":"","firstName":"Kristy","middleName":"P","lastName":"Robledo","suffix":""},{"id":596301193,"identity":"45428d45-6ef1-4681-b60f-28a66b4df012","order_by":1,"name":"Himanshu Popat","email":"","orcid":"","institution":"The University of Sydney","correspondingAuthor":false,"prefix":"","firstName":"Himanshu","middleName":"","lastName":"Popat","suffix":""},{"id":596301194,"identity":"7ab2f7dc-8245-46b0-ac89-b6a65b6b7490","order_by":2,"name":"Isabel Li","email":"","orcid":"","institution":"The University of Sydney","correspondingAuthor":false,"prefix":"","firstName":"Isabel","middleName":"","lastName":"Li","suffix":""},{"id":596301195,"identity":"12efb473-da0b-417b-830d-26c88f23f63e","order_by":3,"name":"Sarah Finlayson","email":"","orcid":"","institution":"The University of Sydney","correspondingAuthor":false,"prefix":"","firstName":"Sarah","middleName":"","lastName":"Finlayson","suffix":""},{"id":596301196,"identity":"91e4a3de-6f04-49c5-9c3c-0e67daf55bbb","order_by":4,"name":"Sailesh Kumar","email":"","orcid":"","institution":"University of Queensland","correspondingAuthor":false,"prefix":"","firstName":"Sailesh","middleName":"","lastName":"Kumar","suffix":""},{"id":596301197,"identity":"c9f9664f-8c4c-4055-a01f-c9c1cadc978e","order_by":5,"name":"Melinda Cruz","email":"","orcid":"","institution":"The University of Sydney","correspondingAuthor":false,"prefix":"","firstName":"Melinda","middleName":"","lastName":"Cruz","suffix":""},{"id":596301198,"identity":"51238b96-db96-45a6-b24f-a320b5818ecc","order_by":6,"name":"Christoph Lehner","email":"","orcid":"","institution":"University of Queensland","correspondingAuthor":false,"prefix":"","firstName":"Christoph","middleName":"","lastName":"Lehner","suffix":""},{"id":596301199,"identity":"20498064-bc33-4f9b-88e7-0c1beee444ba","order_by":7,"name":"Amy Keir","email":"","orcid":"","institution":"Flinders University","correspondingAuthor":false,"prefix":"","firstName":"Amy","middleName":"","lastName":"Keir","suffix":""},{"id":596301200,"identity":"42f99dbe-4bec-4f5f-84c3-f750d20de31e","order_by":8,"name":"Angela Cavallaro","email":"","orcid":"","institution":"The University of Sydney","correspondingAuthor":false,"prefix":"","firstName":"Angela","middleName":"","lastName":"Cavallaro","suffix":""},{"id":596301201,"identity":"cfe5a9fa-0c80-4c7f-b7ee-523f8b4b074c","order_by":9,"name":"Naomi Spotswood","email":"","orcid":"","institution":"Burnet Institute","correspondingAuthor":false,"prefix":"","firstName":"Naomi","middleName":"","lastName":"Spotswood","suffix":""},{"id":596301202,"identity":"d9ebfd68-6e00-48e7-9839-1f724b926f60","order_by":10,"name":"Graeme Polglase","email":"","orcid":"","institution":"Monash University","correspondingAuthor":false,"prefix":"","firstName":"Graeme","middleName":"","lastName":"Polglase","suffix":""},{"id":596301203,"identity":"6d53978a-4e72-47be-a7cc-033ce67e0bca","order_by":11,"name":"Adrienne Gordon","email":"","orcid":"","institution":"Royal Prince Alfred Hospital","correspondingAuthor":false,"prefix":"","firstName":"Adrienne","middleName":"","lastName":"Gordon","suffix":""},{"id":596301204,"identity":"ce8b7630-5b15-43a8-9258-f95c3cd5cbb9","order_by":12,"name":"Khalid Aziz","email":"","orcid":"","institution":"University of Alberta","correspondingAuthor":false,"prefix":"","firstName":"Khalid","middleName":"","lastName":"Aziz","suffix":""},{"id":596301205,"identity":"8179ca46-4cdb-43bb-9cbf-4cee498a5c77","order_by":13,"name":"Kei Lui","email":"","orcid":"","institution":"UNSW Sydney","correspondingAuthor":false,"prefix":"","firstName":"Kei","middleName":"","lastName":"Lui","suffix":""},{"id":596301206,"identity":"14c42d5c-f9cd-4994-b39f-5e45c37e8926","order_by":14,"name":"Ian C Marschner","email":"","orcid":"","institution":"The University of Sydney","correspondingAuthor":false,"prefix":"","firstName":"Ian","middleName":"C","lastName":"Marschner","suffix":""},{"id":596301207,"identity":"c27b1ac5-ce7b-472a-9990-277a6977f722","order_by":15,"name":"William O Tarnow Mordi","email":"","orcid":"","institution":"The University of Sydney","correspondingAuthor":false,"prefix":"","firstName":"William","middleName":"O Tarnow","lastName":"Mordi","suffix":""}],"badges":[],"createdAt":"2026-02-14 01:53:26","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-8876192/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-8876192/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":104402499,"identity":"11cc3edc-f72b-4e81-aeb3-24f8ba1ee79d","added_by":"auto","created_at":"2026-03-11 12:15:32","extension":"pdf","order_by":1,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":692459,"visible":true,"origin":"","legend":"","description":"","filename":"WAMMSAP20260212.pdf","url":"https://assets-eu.researchsquare.com/files/rs-8876192/v1_covered_c21d1d72-899c-458a-9b1a-af5b8176724d.pdf"},{"id":103972774,"identity":"68e7acc4-860e-46e9-81cf-8bdc70179d84","added_by":"auto","created_at":"2026-03-05 07:59:33","extension":"docx","order_by":0,"title":"","display":"","copyAsset":false,"role":"supplement","size":35235,"visible":true,"origin":"","legend":"","description":"","filename":"WAMMSAPSupplementary20260210.docx","url":"https://assets-eu.researchsquare.com/files/rs-8876192/v1/c2dd6fde3292582d3414a611.docx"}],"financialInterests":"No competing interests reported.","formattedTitle":"A pragmatic stepped wedge cluster randomised implementation trial assessing the effect of a quality improvement programme on the proportion of infants achieving delayed cord clamping for more than 60 seconds in infants \u003c37 weeks gestation: Statistical analysis plan for the Wait a Minute or More (WAMM) trial","fulltext":[],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":false,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":true,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":true,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":true,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"
[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"stepped wedge cluster randomised trial, neonatal, statistical analysis plan","lastPublishedDoi":"10.21203/rs.3.rs-8876192/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-8876192/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"The Wait a Minute or More (WAMM) trial is a pragmatic stepped-wedge cluster randomised implementation trial designed to increase the proportion of preterm infants receiving delayed cord clamping for at least 60 seconds (DCC60) across Australian maternity hospitals. This statistical analysis plan prespecifies primary, secondary, and exploratory analyses prior to accessing outcome data. The primary analysis will use mixed-effects modelling to estimate the effect of a locally adapted quality improvement programme and accurate data sharing, on achieving DCC60, accounting for clustering and secular trends. By detailing our approach, this SAP ensures transparency, reproducibility, and rigorous evaluation of the WAMM intervention.","manuscriptTitle":"A pragmatic stepped wedge cluster randomised implementation trial assessing the effect of a quality improvement programme on the proportion of infants achieving delayed cord clamping for more than 60 seconds in infants \u0026lt;37 weeks gestation: Statistical analysis plan for the Wait a Minute or More (WAMM) trial","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2026-03-05 07:59:28","doi":"10.21203/rs.3.rs-8876192/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"
[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"c600334e-a4d4-44dc-adcb-3740ccce3cf3","owner":[],"postedDate":"March 5th, 2026","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2026-03-05T07:59:28+00:00","versionOfRecord":[],"versionCreatedAt":"2026-03-05 07:59:28","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-8876192","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-8876192","identity":"rs-8876192","version":["v1"]},"buildId":"XKTyCvWXoU3ODBz1xrDgd","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}
Text is read by the "Ask this paper" AI Q&A widget below.
Extraction quality varies by source — PMC NXML preserves structure
cleanly, OA-HTML may include some navigation residue, and OA-PDF can
have broken hyphenation. The publisher copy
(via DOI)
is the canonical version.