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,
- Anup C Katheria,
- Venkataseshan Sundaram,
- Lisa Askie,
- Martin Kluckow,
- Shigeharu Hosono,
- Alan Montgomery,
- 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, Hudson Institute of Medical Research, Clayton, Victoria, Australia
- Anup C Katheria
- Neonatology, Sharp Mary Birch Hospital for Women and Newborns, San Diego, California, USA
- Venkataseshan Sundaram
- Neonatology Unit, Department of Pediatrics, Post Graduate Institute of Medical Education and Research, Chandigarh, India
- Lisa Askie
- methodologist
- Martin Kluckow
- Department of Neonatology, University of Sydney, Sydney, New South Wales, Australia
- Shigeharu Hosono
- Department of Perinatal and Neonatal Medicine, Jichi Medical University Saitama Medical Center, Saitama, Japan
- Alan Montgomery
- Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK
- Eugene Dempsey
- Department of Paediatrics and Child Health, Cork University Maternity Hospital, Cork, Ireland
- Walid El-Naggar
- Department of Pediatrics, Dalhousie University, Halifax, Nova Scotia, Canada
- William Tarnow-Mordi
- NHMRC Clinical Trials Centre, The University of Sydney, Sydney, New South Wales, Australia
- Heike Rabe
- 1 Trevor Mann Baby Unit, Brighton and Sussex University Hospitals NHS Trust, Brighton, UK
- Ronny Knol
- Lelia Duley
- Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK
- Thomas Debray
- Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands
- Amir Kugelman
- Kellie Murphy
- 5 Department of Obstetrics and Gynecology, Mount Sinai Hospital, Toronto, Ontario, Canada
- Anna Lene Seidler
- NHMRC Clinical Trials Centre, The University of Sydney, Sydney, New South Wales, Australia
- Kylie E Hunter
- NHMRC Clinical Trials Centre, The University of Sydney, Sydney, New South Wales, Australia
- Michael Meyer
- 1 Institute for 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
- Department of Clinical Sciences Lund, Pediatrics/Neonatology, Skane University Hospital, Lund University, Lund, Sweden
- Vikram Datta
- Department of Neonatology, Kalawati Saran Children’s Hospital, Lady Hardinge Medical College, New 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
- 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
- 1 Chakri Naruebodindra Medical Institute, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bang Phli, Samut Prakan, Thailand
- G Ram Mohan
- Gillian Gyte
- National Childbirth Trust, London, UK
- Guillermo Carroli
- Heidi Al-Wassia
- Hytham Atia
- Islam Nour
- Jiangqin Liu
- 6 Neonatology, Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine, Shanghai, China
- John Bauer
- Kristy Robledo
- Lakhbir Dhaliwal
- 3Department of Obstetrics and Gynaecology, Pgimer, Chandigarh, India
- Laura Perretta
- Lin Ling
- Manoj Varanattu
- Maria Goya
- 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
- School of Clinical Medicine, University of Cambridge, Cambridge, UK
- Simone Pratesi
- 14 Division of Neonatology, Careggi University Hospital, Florence, Italy
- Thomas Ranjit
- Victor Lago Leal
- Waldemar Carlo
- DOI
- https://doi.org/10.1136/bmjopen-2019-034595
- Journal volume & issue
-
Vol. 10,
no. 3
Abstract
IntroductionTiming 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 analysisSystematic 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 disseminationEthics 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 numberAustralian New Zealand Clinical Trials Registry (ANZCTR) (ACTRN12619001305112) and International Prospective Register of Systematic Reviews (PROSPERO, CRD42019136640).
