. 2020 Mar 29;10(3):e034595.

doi: 10.1136/bmjopen-2019-034595.

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

Anna Lene Seidler¹, Lelia Duley², Anup C Katheria³, Catalina De Paco Matallana⁴, Eugene Dempsey⁵, Heike Rabe⁶, John Kattwinkel⁷, Judith Mercer⁸, Justin Josephsen⁹, Karen Fairchild⁷, Ola Andersson¹⁰, Shigeharu Hosono¹¹, Venkataseshan Sundaram¹², Vikram Datta¹³, Walid El-Naggar¹⁴, William Tarnow-Mordi¹⁵, Thomas Debray¹⁶, Stuart B Hooper¹⁷, Martin Kluckow¹⁸, Graeme Polglase¹⁷, Peter G Davis¹⁹, Alan Montgomery², Kylie E Hunter¹⁵, Angie Barba¹⁵, John Simes¹⁵, Lisa Askie¹⁵; iCOMP Collaboration

Collaborators, Affiliations

Collaborators

Affiliations

¹ NHMRC Clinical Trials Centre, The University of Sydney, Sydney, New South Wales, Australia lene.seidler@ctc.usyd.edu.au.
² Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.
³ Neonatal Research Institute, Sharp Mary Birch Hospital for Women & Newborns, San Diego, California, USA.
⁴ Department of Obstetrics and Gynecology, Clinic University Hospital Virgen de la Arrixaca, Murcia, Spain.
⁵ Department of Paediatrics and Child Health, Cork University Maternity Hospital, Cork, Ireland.
⁶ Academic Department of Paediatrics, Brighton and Sussex University Hospitals, Brighton, UK.
⁷ Department of Pediatrics and Medicine, University of Virginia, Charlottesville, Virginia, USA.
⁸ College of Nursing, University of Rhode Island, Kingston, Rhode Island, USA.
⁹ Department of Pediatrics, St Louis University School of Medicine, St Louis, Missouri, USA.
¹⁰ Department of Clinical Sciences Lund, Pediatrics/Neonatology, Skane University Hospital, Lund University, Lund, Sweden.
¹¹ Department of Perinatal and Neonatal Medicine, Jichi Medical University Saitama Medical Center, Saitama, Japan.
¹² Newborn Unit, Department of Pediatrics, Postgraduate Institute of Medical Education and Research, Chandigarh, India.
¹³ Department of Neonatology, Lady Hardinge Medical College, New Delhi, India.
¹⁴ Department of Pediatrics, Dalhousie University, Halifax, Nova Scotia, Canada.
¹⁵ NHMRC Clinical Trials Centre, The University of Sydney, Sydney, New South Wales, Australia.
¹⁶ Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.
¹⁷ The Ritchie Centre, Obstetrics & Gynaecology, Monash University, Clayton, Victoria, Australia.
¹⁸ Department of Neonatology, University of Sydney, Sydney, New South Wales, Australia.
¹⁹ Newborn Research Centre, The Royal Women's Hospital, Melbourne, Victoria, Australia.

PMID: 32229522
PMCID: PMC7170588
DOI: 10.1136/bmjopen-2019-034595

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

Anna Lene Seidler et al. BMJ Open. 2020.

. 2020 Mar 29;10(3):e034595.

doi: 10.1136/bmjopen-2019-034595.

Authors

Collaborators

Affiliations

¹ NHMRC Clinical Trials Centre, The University of Sydney, Sydney, New South Wales, Australia lene.seidler@ctc.usyd.edu.au.
² Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.
³ Neonatal Research Institute, Sharp Mary Birch Hospital for Women & Newborns, San Diego, California, USA.
⁴ Department of Obstetrics and Gynecology, Clinic University Hospital Virgen de la Arrixaca, Murcia, Spain.
⁵ Department of Paediatrics and Child Health, Cork University Maternity Hospital, Cork, Ireland.
⁶ Academic Department of Paediatrics, Brighton and Sussex University Hospitals, Brighton, UK.
⁷ Department of Pediatrics and Medicine, University of Virginia, Charlottesville, Virginia, USA.
⁸ College of Nursing, University of Rhode Island, Kingston, Rhode Island, USA.
⁹ Department of Pediatrics, St Louis University School of Medicine, St Louis, Missouri, USA.
¹⁰ Department of Clinical Sciences Lund, Pediatrics/Neonatology, Skane University Hospital, Lund University, Lund, Sweden.
¹¹ Department of Perinatal and Neonatal Medicine, Jichi Medical University Saitama Medical Center, Saitama, Japan.
¹² Newborn Unit, Department of Pediatrics, Postgraduate Institute of Medical Education and Research, Chandigarh, India.
¹³ Department of Neonatology, Lady Hardinge Medical College, New Delhi, India.
¹⁴ Department of Pediatrics, Dalhousie University, Halifax, Nova Scotia, Canada.
¹⁵ NHMRC Clinical Trials Centre, The University of Sydney, Sydney, New South Wales, Australia.
¹⁶ Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.
¹⁷ The Ritchie Centre, Obstetrics & Gynaecology, Monash University, Clayton, Victoria, Australia.
¹⁸ Department of Neonatology, University of Sydney, Sydney, New South Wales, Australia.
¹⁹ Newborn Research Centre, The Royal Women's Hospital, Melbourne, Victoria, Australia.

PMID: 32229522
PMCID: PMC7170588
DOI: 10.1136/bmjopen-2019-034595

Abstract

Introduction: Timing 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.

Objectives: (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.

Methods and analysis: 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 and dissemination: 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.

Registration number: Australian New Zealand Clinical Trials Registry (ANZCTR) (ACTRN12619001305112) and International Prospective Register of Systematic Reviews (PROSPERO, CRD42019136640).

Keywords: individual participant data meta-analysis; network meta-analysis; placental transfusion; preterm birth; prospective meta-analysis; umbilical cord clamping; umbilical cord milking.

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Conflict of interest statement

Competing interests: LD, ACK, CDPM, ED, HR, JK, JM, JJ, KF, OA, SH, VS, VD, WE-N and WT-M are Chief Investigators for potentially eligible trials.

Figures

**Figure 1**
Network of possible comparisons between cord management interventions.

**Figure 2**
Illustration of network of currently available trials comparing different timings of cord clamping.

See this image and copyright information in PMC

References

1. Blencowe H, Cousens S, Oestergaard MZ, et al. . National, regional, and worldwide estimates of preterm birth rates in the year 2010 with time trends since 1990 for selected countries: a systematic analysis and implications. Lancet 2012;379:2162–72. 10.1016/S0140-6736(12)60820-4 - DOI - PubMed
1. March of Dimes, PMNCH, Save the Children . WHO : Howson CP, Kinney MV, Lawn JE, Born too soon: the global action report on preterm birth. Geneva: World Health Organisation, 2012.
1. Chang HH, Larson J, Blencowe H, et al. . Preventing preterm births: analysis of trends and potential reductions with interventions in 39 countries with very high human development index. Lancet 2013;381:223–34. 10.1016/S0140-6736(12)61856-X - DOI - PMC - PubMed
1. Petrou S, Mehta Z, Hockley C, et al. . The impact of preterm birth on hospital inpatient admissions and costs during the first 5 years of life. Pediatrics 2003;112:1290–7. 10.1542/peds.112.6.1290 - DOI - PubMed
1. Mangham LJ, Petrou S, Doyle LW, et al. . The cost of preterm birth throughout childhood in England and Wales. Pediatrics 2009;123:e312–27. 10.1542/peds.2008-1827 - DOI - PubMed

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

Collaborators

Affiliations

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

Authors

Collaborators

Affiliations

Abstract

Conflict of interest statement

Figures

References

Publication types

MeSH terms

Associated data

LinkOut - more resources

Full Text Sources