Systematic review and network meta-analysis with individual participant data on cord management at preterm birth (iCOMP): study protocol

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dc.contributor.authorSeidler, Anna Lene
dc.contributor.authorDuley, Lelia
dc.contributor.authorKatheria, Anup C.
dc.contributor.authorDe Paco Matallana, Catalina
dc.contributor.authorDempsey, Eugene M.
dc.contributor.authorRabe, Heike
dc.contributor.authorKattwinkel, John
dc.contributor.authorMercer, Judith
dc.contributor.authorJosephsen, Justin
dc.contributor.authorFairchild, Karen
dc.contributor.authorAndersson, Ola
dc.contributor.authorHosono, Shigeharu
dc.contributor.authorSundaram, Venkataseshan
dc.contributor.authorDatta, Vikram
dc.contributor.authorEl-Naggar, Walid
dc.contributor.authorTarnow-Mordi, William
dc.contributor.authorDebray, Thomas
dc.contributor.authorHooper, Stuart B.
dc.contributor.authorKluckow, Martin
dc.contributor.authorPolglase, Graeme
dc.contributor.authorDavis, Peter G.
dc.contributor.authorMontgomery, Alan
dc.contributor.authorHunter, Kylie E.
dc.contributor.authorBarba, Angie
dc.contributor.authorSimes, John
dc.contributor.authorAskie, Lisa
dc.contributor.funderUK National Institute of Health Researchen
dc.date.accessioned2022-05-13T11:33:55Z
dc.date.available2022-05-13T11:33:55Z
dc.date.issued2020-03
dc.date.updated2022-05-13T11:04:26Z
dc.description.abstractTiming of cord clamping and other cord management strategies may improve outcomes at preterm birth. However, it is unclear whether benefits apply to all preterm subgroups. Previous and current trials compare various policies, including time-based or physiology-based deferred cord clamping, and cord milking. Individual participant data (IPD) enable exploration of different strategies within subgroups. Network meta-analysis (NMA) enables comparison and ranking of all available interventions using a combination of direct and indirect comparisons. (1) To evaluate the effectiveness of cord management strategies for preterm infants on neonatal mortality and morbidity overall and for different participant characteristics using IPD meta-analysis. (2) To evaluate and rank the effect of different cord management strategies for preterm births on mortality and other key outcomes using NMA. Systematic searches of Medline, Embase, clinical trial registries, and other sources for all ongoing and completed randomised controlled trials comparing cord management strategies at preterm birth (before 37 weeks' gestation) have been completed up to 13 February 2019, but will be updated regularly to include additional trials. IPD will be sought for all trials; aggregate summary data will be included where IPD are unavailable. First, deferred clamping and cord milking will be compared with immediate clamping in pairwise IPD meta-analyses. The primary outcome will be death prior to hospital discharge. Effect differences will be explored for prespecified participant subgroups. Second, all identified cord management strategies will be compared and ranked in an IPD NMA for the primary outcome and the key secondary outcomes. Treatment effect differences by participant characteristics will be identified. Inconsistency and heterogeneity will be explored. Ethics approval for this project has been granted by the University of Sydney Human Research Ethics Committee (2018/886). Results will be relevant to clinicians, guideline developers and policy-makers, and will be disseminated via publications, presentations and media releases. Australian New Zealand Clinical Trials Registry (ANZCTR) (ACTRN12619001305112) and International Prospective Register of Systematic Reviews (PROSPERO, CRD42019136640).en
dc.description.sponsorshipUK National Institute of Health Research (“The Preterm Birth Programme” number RPPG060910107)en
dc.description.statusPeer revieweden
dc.description.versionPublished Versionen
dc.format.mimetypeapplication/pdfen
dc.identifier.articleide034595en
dc.identifier.citationSeidler, A. L., Duley, L., Katheria, A. C., De Paco Matallana, C., Dempsey, E. M., Rabe, H., Kattwinkel, J., Mercer, J., Josephsen, J., Fairchild, K., Andersson, O., Hosono, S., Sundaram, V., Datta, V., El-Naggar, W., Tarnow-Mordi, W., Debray, T., Hooper, S. B., Kluckow, M., Polglase, G., Davis, P. G., Montgomery, A., Hunter, K. E., Barba, A., Simes, J. and Askie, L. (2020) 'Systematic review and network meta-analysis with individual participant data on cord management at preterm birth (iCOMP): study protocol', BMJ Open, 10 (3), e034595 (12pp). doi: 10.1136/bmjopen-2019-034595en
dc.identifier.doi10.1136/bmjopen-2019-034595en
dc.identifier.endpage12en
dc.identifier.issn2044-6055
dc.identifier.issued3en
dc.identifier.journaltitleBMJ Openen
dc.identifier.startpage1en
dc.identifier.urihttps://hdl.handle.net/10468/13179
dc.identifier.volume10en
dc.language.isoenen
dc.publisherBMJ Publishing Groupen
dc.rights© Author(s) (or their employer(s)) 2020. Re- use permitted under CC BY. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https:// creativecommons. org/ licenses/by/4.0/.en
dc.rights.urihttps://creativecommons.org/licenses/by/4.0/en
dc.subjectIndividual participant data meta-analysisen
dc.subjectNetwork meta-analysisen
dc.subjectPlacental transfusionen
dc.subjectPreterm birthen
dc.subjectProspective meta-analysisen
dc.subjectUmbilical cord clampingen
dc.subjectUmbilical cord milkingen
dc.titleSystematic review and network meta-analysis with individual participant data on cord management at preterm birth (iCOMP): study protocolen
dc.typeArticle (peer-reviewed)en
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