BMJ Open (Mar 2020)
Systematic review and network meta-analysis with individual participant data on cord management at preterm birth (iCOMP): study protocol
- Stuart B Hooper,
- Peter G Davis,
- Anup C Katheria,
- Venkataseshan Sundaram,
- Lisa Askie,
- Martin Kluckow,
- Shigeharu Hosono,
- Eugene Dempsey,
- Walid El-Naggar,
- William Tarnow-Mordi,
- Heike Rabe,
- Ronny Knol,
- Lelia Duley,
- Thomas Debray,
- Amir Kugelman,
- Kellie Murphy,
- Anna Lene Seidler,
- Kylie E Hunter,
- Michael Meyer,
- Catalina De Paco Matallana,
- John Kattwinkel,
- Judith Mercer,
- Justin Josephsen,
- Karen Fairchild,
- Ola Andersson,
- Vikram Datta,
- Graeme Polglase,
- Angie Barba,
- John Simes,
- Ava Grace Tan-Koay,
- Anu George,
- Anu Sachdeva,
- Arjan Te Pas,
- Ashish K C,
- Bimlesh Kumar,
- Carl Backes,
- Chamnan Tanprasertkul,
- Chayatat Ruangkit,
- G Ram Mohan,
- Gillian Gyte,
- Guillermo Carroli,
- Heidi Al-Wassia,
- Hytham Atia,
- Islam Nour,
- Jiangqin Liu,
- John Bauer,
- Kristy Robledo,
- Lakhbir Dhaliwal,
- Laura Perretta,
- Lin Ling,
- Manoj Varanattu,
- Maria Goya,
- Musa Silahli,
- Neelam Kler,
- Neil Finer,
- Omar Kamlin,
- Peter Giannone,
- Pharuhad Pongmee,
- Prisana Panichkul,
- Sandeep Kadam,
- Sangkae Chamnanvanakij,
- Shiraz Badurdeen,
- Simone Pratesi,
- Thomas Ranjit,
- Victor Lago Leal,
- Waldemar Carlo
Affiliations
- Stuart B Hooper
- 3 The Ritchie Centre at Hudson Institute of Medical Research, Clayton, Victoria, Australia
- Peter G Davis
- 1 Newborn Research Centre, The Royal Women`s Hospital, Melbourne, Victoria, Australia
- Anup C Katheria
- Neonatology, Sharp Mary Birch Hospital for Women and Newborns, San Diego, California, USA
- Venkataseshan Sundaram
- Paediatrics, Post Graduate Institute of Medical Education and Research, Chandigarh, Chandigarh, India
- Lisa Askie
- NHMRC Clinical Trials Centre, The University of Sydney, Sydney, New South Wales, Australia
- Martin Kluckow
- 9 Department of Neonatology, Royal North Shore Hospital, St Leonards, New South Wales, Australia
- Shigeharu Hosono
- Department of Perinatal and Neonatal Medicine, Jichi Medical University Saitama Medical Center, Saitama, Japan
- Eugene Dempsey
- Department of Paediatrics and Child Health, University College Cork, Cork, Ireland
- Walid El-Naggar
- 2 Division of Neonatal Perinatal Medicine, IWK Health, Halifax, Nova Scotia, Canada
- William Tarnow-Mordi
- NHMRC Clinical Trials Centre, The University of Sydney, Sydney, New South Wales, Australia
- Heike Rabe
- Academic Department of Paediatrics, Royal Alexandra Children`s Hospital, University Hospitals Sussex NHS Foundation Trust, Brighton, UK
- Ronny Knol
- Division of Neonatology, Department of Paediatrics, Erasmus MC University Medical Center, Rotterdam, The Netherlands
- Lelia Duley
- professor of clinical trials research
- Thomas Debray
- senior statistician
- Amir Kugelman
- Kellie Murphy
- 2 Department of Obstetrics and Gynecology, University of Toronto, Toronto, ON, Canada
- Anna Lene Seidler
- Centre for Research Excellence in the Early Prevention of Obesity in Childhood, University of Sydney, Sydney, New South Wales, Australia
- Kylie E Hunter
- senior evidence analyst
- Michael Meyer
- Institute of Preventive Pediatrics, Technical University of Munich, Munich, Germany
- Catalina De Paco Matallana
- Department of Obstetrics and Gynecology, Clinic University Hospital Virgen de la Arrixaca, Murcia, Spain
- John Kattwinkel
- Department of Pediatrics and Medicine, University of Virginia, Charlottesville, Virginia, USA
- Judith Mercer
- College of Nursing, University of Rhode Island, Kingston, Rhode Island, USA
- Justin Josephsen
- Department of Pediatrics, St Louis University School of Medicine, St Louis, Missouri, USA
- Karen Fairchild
- Department of Pediatrics and Medicine, University of Virginia, Charlottesville, Virginia, USA
- Ola Andersson
- 1 Department of Clinical Sciences Lund, Paediatrics, Lund University, Lund, Sweden
- Vikram Datta
- Department of Neonatology, Kalawati Saran Children`s Hospital, New Delhi, Delhi, India
- Graeme Polglase
- The Ritchie Centre, Obstetrics & Gynaecology, Monash University, Clayton, Victoria, Australia
- Angie Barba
- NHMRC Clinical Trials Centre, The University of Sydney, Sydney, New South Wales, Australia
- John Simes
- 4 NHMRC Clinical Trials Centre, The University of Sydney, Sydney, New South Wales, Australia
- Ava Grace Tan-Koay
- Anu George
- Anu Sachdeva
- Arjan Te Pas
- Ashish K C
- Bimlesh Kumar
- Carl Backes
- Chamnan Tanprasertkul
- Chayatat Ruangkit
- G Ram Mohan
- Gillian Gyte
- National Childbirth Trust, London, UK
- Guillermo Carroli
- Centro Rosarino de Estudios Perinatales (CREP), Rosario, Argentina
- Heidi Al-Wassia
- Hytham Atia
- Islam Nour
- Jiangqin Liu
- John Bauer
- Kristy Robledo
- Biostatistics and Research Methodology, University of Sydney NHMRC Clinical Trials Centre, Sydney, New South Wales, Australia
- Lakhbir Dhaliwal
- Laura Perretta
- Lin Ling
- Department of Emergency, The Second Affiliated Hospital, Hengyang Medical School, University of South China, Hengyang, China
- Manoj Varanattu
- Maria Goya
- Hospital Universitario Vall dHebron, Barcelona, Spain
- Musa Silahli
- Neelam Kler
- Neil Finer
- University of California San Diego, La Jolla, California, USA
- Omar Kamlin
- Peter Giannone
- Pharuhad Pongmee
- Prisana Panichkul
- Sandeep Kadam
- Sangkae Chamnanvanakij
- Shiraz Badurdeen
- 1 The Ritchie Centre, Hudson Institute of Medical Research, Clayton, Victoria, Australia
- Simone Pratesi
- Thomas Ranjit
- Victor Lago Leal
- Waldemar Carlo
- DOI
- https://doi.org/10.1136/bmjopen-2019-034595
- Journal volume & issue
-
Vol. 10,
no. 3
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).
