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Systematic review and network meta-analysis with individual participant data on cord management at preterm birth (iCOMP): study protocol
  1. Anna Lene Seidler1,
  2. Lelia Duley2,
  3. Anup C Katheria3,
  4. Catalina De Paco Matallana4,
  5. Eugene Dempsey5,
  6. Heike Rabe6,
  7. John Kattwinkel7,
  8. Judith Mercer8,
  9. Justin Josephsen9,
  10. Karen Fairchild7,
  11. Ola Andersson10,
  12. Shigeharu Hosono11,
  13. Venkataseshan Sundaram12,
  14. Vikram Datta13,
  15. Walid El-Naggar14,
  16. William Tarnow-Mordi1,
  17. Thomas Debray15,
  18. Stuart B Hooper16,
  19. Martin Kluckow17,
  20. Graeme Polglase16,
  21. Peter G Davis18,
  22. Alan Montgomery2,
  23. Kylie E Hunter1,
  24. Angie Barba1,
  25. John Simes1,
  26. Lisa Askie1
  27. On behalf of the iCOMP Collaboration
    1. 1NHMRC Clinical Trials Centre, The University of Sydney, Sydney, New South Wales, Australia
    2. 2Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK
    3. 3Neonatal Research Institute, Sharp Mary Birch Hospital for Women & Newborns, San Diego, California, USA
    4. 4Department of Obstetrics and Gynecology, Clinic University Hospital Virgen de la Arrixaca, Murcia, Spain
    5. 5Department of Paediatrics and Child Health, Cork University Maternity Hospital, Cork, Ireland
    6. 6Academic Department of Paediatrics, Brighton and Sussex University Hospitals, Brighton, UK
    7. 7Department of Pediatrics and Medicine, University of Virginia, Charlottesville, Virginia, USA
    8. 8College of Nursing, University of Rhode Island, Kingston, Rhode Island, USA
    9. 9Department of Pediatrics, St Louis University School of Medicine, St Louis, Missouri, USA
    10. 10Department of Clinical Sciences Lund, Pediatrics/Neonatology, Skane University Hospital, Lund University, Lund, Sweden
    11. 11Department of Perinatal and Neonatal Medicine, Jichi Medical University Saitama Medical Center, Saitama, Japan
    12. 12Newborn Unit, Department of Pediatrics, Postgraduate Institute of Medical Education and Research, Chandigarh, India
    13. 13Department of Neonatology, Lady Hardinge Medical College, New Delhi, India
    14. 14Department of Pediatrics, Dalhousie University, Halifax, Nova Scotia, Canada
    15. 15Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands
    16. 16The Ritchie Centre, Obstetrics & Gynaecology, Monash University, Clayton, Victoria, Australia
    17. 17Department of Neonatology, University of Sydney, Sydney, New South Wales, Australia
    18. 18Newborn Research Centre, The Royal Women’s Hospital, Melbourne, Victoria, Australia
    1. Correspondence to Anna Lene Seidler; lene.seidler{at}ctc.usyd.edu.au

    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).

    • preterm birth
    • umbilical cord clamping
    • umbilical cord milking
    • placental transfusion
    • individual participant data meta-analysis
    • network meta-analysis
    • prospective meta-analysis
    https://creativecommons.org/licenses/by/4.0/

    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/.

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    Footnotes

    • Twitter @LeneSeidler, @TPA_Debray

    • Collaborators iCOMP Collaboration members: Secretariat: Angie Barba, Anna Lene Seidler, Ava Grace Tan-Koay, Kylie E Hunter, Lisa Askie (NHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia); Alan Montgomery, Lelia Duley (Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK). Trialists: Amir Kugelman (Bnai Zion Medical Center, Haifa, Israel); Anu George (Malankara Orthodox Syrian Church Medical College, Kerala, India); Anu Sachdeva (All India Institute of Medical Science, New Delhi, India); Anup Katheria (Sharp Mary Birch Hospital for Women & Newborns, San Diego, California, USA); Arjan Te Pas (Leiden University, Leiden, The Netherlands); Ashish K C (Uppsala University, Uppsala, Sweden); Bimlesh Kumar (Lala Lajpat Rai Memorial Medical College, Uttar Pradash, India); Carl Backes (Ohio State University Wexner Medical Center, Columbus, Ohio, USA); Catalina De Paco Matallana (Clinic University Hospital Virgen de la Arrixaca, Murcia, Spain); Chamnan Tanprasertkul (Thammasat University, Pathumthani, Thailand); Chayatat Ruangkit (Mahidol University, Samut Prakan, Thailand); Eugene Dempsey (Cork University Maternity Hospital, Cork, Ireland); G Ram Mohan, Lakhbir Dhaliwal, Venkataseshan Sundaram (Post Graduate Institute of Medical Education & Research, Chandigarh, India); Gillian Gyte (Oldfield, Poulton le Fylde, UK), Guillermo Carroli (Rosarino Center for Perinatal Studies, Rosario, Argentina); Heidi Al-Wassia (King Abdulaziz University, Jeddah, Saudi Arabia); Hytham Atia (Zagazig University, Zagazig, Egypt); Heike Rabe (Brighton and Sussex Medical School, University of Sussex, Brighton, UK); Islam Nour (Mansoura University Children’s Hospital, Mansoura, Egypt); Jiangqin Liu (Tongji University School of Medicine, Shanghai, China), John Kattwinkel, Karen Fairchild (University of Virginia, Charlottesville, Virginia, USA); Judith Mercer (The University of Rhode Island, Kingston, Rhode Island, USA), Justin Josephsen (St Louis University School of Medicine, St. Louis, Missouri, USA), Kellie Murphy (Mount Sinai Hospital, Toronto, Canada); Kristy Robledo, William Tarnow-Mordi (NHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia); Laura Perretta (Weill Cornell Medical College, New York City, New York, USA); Lin Ling (Suining Central Hospital, Sichuan, China); Manoj Varanattu (Jubilee Mission Medical College & Research Centre, Kerala, India); Maria Goya (Vall d’Hebron University Hospital, Barcelona, Spain); Michael Meyer (Middlemore Hospital, Auckland, New Zealand); Musa Silahli (Baskent University, Ankara, Turkey); Neelam Kler (Sir Ganga Ram Hospital, New Delhi, India); Neil Finer (University of California, San Diego, California, USA); Ola Andersson (Skane University Hospital, Lund University, Lund, Sweden); Omar Kamlin, Shiraz Badurdeen (The Royal Women’s Hospital, Melbourne, Australia); Pharuhad Pongmee (Ramathibodi Hospital, Mahidol University, Bangkok, Thailand); Prisana Panichkul, Sangkae Chamnanvanakij (Phramongkutklao Hospital, Ratchathewi, Bangkok, Thailand); Ronny Knol (Erasmus MC, University Medical Centre, Rotterdam, The Netherlands); Sandeep Kadam (KEM Hospital, Pune, Maharashtra, India); Shigeharu Hosono (Jichi Medical University Saitama Medical Center, Saitama, Japan); Simone Pratesi (University of Florence, Florence, Italy); Thomas Ranjit (St John’s Medical College & Hospital, Bangalore, Kamataka, India); Victor Lago Leal (University Hospital of Getafe & European University of Madrid, Madrid, Spain); Vikram Datta (Lady Hardinge Medical College, New Delhi, India); Waldemar Carlo (University of Alabama at Birmingham, Birmingham, Alabama, USA), Walid El-Naggar (Dalhousie University, Halifax, Canada). Advisers: Graeme Polglase, Stuart Hooper (The Ritchie Centre, Obstetrics & Gynaecology, Monash University, Melbourne, Australia); John Simes (NHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia); Martin Kluckow (University of Sydney, Sydney, Australia); Peter Davis (The Royal Women’s Hospital, Melbourne, Australia); Thomas P.A. Debray (Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, the Netherlands)

    • Contributors LD and LA conceived the idea. ALS, LA and LD drafted the protocol. All remaining authors (ACK, CDPM, ED, HR, JK, JM, JJ, KF, OA, SH, VS, VD, WE-N, WT-M, TD, SBH, MK, GP, PGD, AM, KEH, AB and JS) critically revised all drafts of the manuscript for intellectual content, and agreed and approved the final manuscript. ALS is the guarantor of the review.

    • Funding Support for developing the protocol and establishing the collaborative group was received from the UK National Institute of Health Research with a grant entitled “The Preterm Birth Programme” (number RPPG060910107). This grant presents independent research commissioned by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research funding scheme (RP-PG0609-10107). The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health. Funding for individual trials remains the responsibility of the trialists themselves. Funding to undertake data collection and data analysis for the iCOMP Collaboration has been provided by the Australian National Health and Medical Research Council via a Project Grant (APP1163585).

    • 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.

    • Patient consent for publication Not required.

    • Provenance and peer review Not commissioned; externally peer reviewed.

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