Systematic review and network meta-analysis with individual participant data on cord management at preterm birth (iCOMP): study protocol
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 clampi...
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2020-03-01
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| author | 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 |
| author_facet | 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 |
| author_sort | Stuart B Hooper |
| collection | DOAJ |
| description | 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). |
| format | Article |
| id | doaj-art-b362a4cd732b4db184018fd18165da0c |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-03-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-b362a4cd732b4db184018fd18165da0c2025-08-20T02:21:03ZengBMJ Publishing GroupBMJ Open2044-60552020-03-0110310.1136/bmjopen-2019-034595Systematic review and network meta-analysis with individual participant data on cord management at preterm birth (iCOMP): study protocolStuart B Hooper0Peter G Davis1Anup C Katheria2Venkataseshan Sundaram3Lisa Askie4Martin Kluckow5Shigeharu Hosono6Eugene Dempsey7Walid El-Naggar8William Tarnow-Mordi9Heike Rabe10Ronny Knol11Lelia Duley12Thomas Debray13Amir KugelmanKellie Murphy14Anna Lene Seidler15Kylie E Hunter16Michael Meyer17Catalina De Paco Matallana18John Kattwinkel19Judith Mercer20Justin Josephsen21Karen Fairchild22Ola Andersson23Vikram Datta24Graeme Polglase25Angie Barba26John Simes27Ava Grace Tan-KoayAnu GeorgeAnu SachdevaArjan Te PasAshish K CBimlesh KumarCarl BackesChamnan TanprasertkulChayatat RuangkitG Ram MohanGillian Gyte28Guillermo Carroli29Heidi Al-WassiaHytham AtiaIslam NourJiangqin LiuJohn BauerKristy Robledo30Lakhbir DhaliwalLaura PerrettaLin Ling31Manoj VaranattuMaria Goya32Musa SilahliNeelam KlerNeil Finer33Omar KamlinPeter GiannonePharuhad PongmeePrisana PanichkulSandeep KadamSangkae ChamnanvanakijShiraz Badurdeen34Simone PratesiThomas RanjitVictor Lago LealWaldemar Carlo3 The Ritchie Centre at Hudson Institute of Medical Research, Clayton, Victoria, Australia1 Newborn Research Centre, The Royal Women`s Hospital, Melbourne, Victoria, AustraliaNeonatology, Sharp Mary Birch Hospital for Women and Newborns, San Diego, California, USAPaediatrics, Post Graduate Institute of Medical Education and Research, Chandigarh, Chandigarh, IndiaNHMRC Clinical Trials Centre, The University of Sydney, Sydney, New South Wales, Australia9 Department of Neonatology, Royal North Shore Hospital, St Leonards, New South Wales, AustraliaDepartment of Perinatal and Neonatal Medicine, Jichi Medical University Saitama Medical Center, Saitama, JapanDepartment of Paediatrics and Child Health, University College Cork, Cork, Ireland2 Division of Neonatal Perinatal Medicine, IWK Health, Halifax, Nova Scotia, CanadaNHMRC Clinical Trials Centre, The University of Sydney, Sydney, New South Wales, AustraliaAcademic Department of Paediatrics, Royal Alexandra Children`s Hospital, University Hospitals Sussex NHS Foundation Trust, Brighton, UKDivision of Neonatology, Department of Paediatrics, Erasmus MC University Medical Center, Rotterdam, The Netherlandsprofessor of clinical trials researchsenior statistician2 Department of Obstetrics and Gynecology, University of Toronto, Toronto, ON, CanadaCentre for Research Excellence in the Early Prevention of Obesity in Childhood, University of Sydney, Sydney, New South Wales, Australiasenior evidence analystInstitute of Preventive Pediatrics, Technical University of Munich, Munich, GermanyDepartment of Obstetrics and Gynecology, Clinic University Hospital Virgen de la Arrixaca, Murcia, SpainDepartment of Pediatrics and Medicine, University of Virginia, Charlottesville, Virginia, USACollege of Nursing, University of Rhode Island, Kingston, Rhode Island, USADepartment of Pediatrics, St Louis University School of Medicine, St Louis, Missouri, USADepartment of Pediatrics and Medicine, University of Virginia, Charlottesville, Virginia, USA1 Department of Clinical Sciences Lund, Paediatrics, Lund University, Lund, SwedenDepartment of Neonatology, Kalawati Saran Children`s Hospital, New Delhi, Delhi, IndiaThe Ritchie Centre, Obstetrics & Gynaecology, Monash University, Clayton, Victoria, AustraliaNHMRC Clinical Trials Centre, The University of Sydney, Sydney, New South Wales, Australia4 NHMRC Clinical Trials Centre, The University of Sydney, Sydney, New South Wales, AustraliaNational Childbirth Trust, London, UKCentro Rosarino de Estudios Perinatales (CREP), Rosario, ArgentinaBiostatistics and Research Methodology, University of Sydney NHMRC Clinical Trials Centre, Sydney, New South Wales, AustraliaDepartment of Emergency, The Second Affiliated Hospital, Hengyang Medical School, University of South China, Hengyang, ChinaHospital Universitario Vall dHebron, Barcelona, SpainUniversity of California San Diego, La Jolla, California, USA1 The Ritchie Centre, Hudson Institute of Medical Research, Clayton, Victoria, AustraliaIntroduction 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).https://bmjopen.bmj.com/content/10/3/e034595.full |
| spellingShingle | 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 Systematic review and network meta-analysis with individual participant data on cord management at preterm birth (iCOMP): study protocol BMJ Open |
| title | Systematic review and network meta-analysis with individual participant data on cord management at preterm birth (iCOMP): study protocol |
| title_full | Systematic review and network meta-analysis with individual participant data on cord management at preterm birth (iCOMP): study protocol |
| title_fullStr | Systematic review and network meta-analysis with individual participant data on cord management at preterm birth (iCOMP): study protocol |
| title_full_unstemmed | Systematic review and network meta-analysis with individual participant data on cord management at preterm birth (iCOMP): study protocol |
| title_short | Systematic review and network meta-analysis with individual participant data on cord management at preterm birth (iCOMP): study protocol |
| title_sort | systematic review and network meta analysis with individual participant data on cord management at preterm birth icomp study protocol |
| url | https://bmjopen.bmj.com/content/10/3/e034595.full |
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