No additional acknowledgements.
Oversight Committees
Project Management Group and Co-Investigator Group
The trial will be supervised on a day-to-day basis by a Project Management Group based at the National Perinatal Epidemiological Unit Clinical Trials Unit with the input of the chief investigator. The Co-Investigator Group will meet (in person or by teleconference) at least twice a year. This will comprise all co-applicants and the members of the core Project Management Group.
Project Management Group members:
Professor Lucy Chappell: NIHR Research Professor in Obstetrics, King’s College London
Sue Tohill: Joint Lead Trial Research Midwife, St Thomas’ Hospital, London
Amanda Redford: Joint Lead Trial Research Midwife, University of Nottingham, Nottingham
National Perinatal Epidemiology Unit Clinical Trials Unit, University of Oxford, Oxford:
Associate Professor Edmund Juszczak: Director
Ursula Bowler: Senior Trials Manager
Louise Linsell: Senior Statistician
Jennifer Bell: Trial Statistician
Anne Smith: Trial Coordinator
Catherine Rounding: Trial Administrator
Co-investigator Group:
Professor Lucy Chappell: NIHR Research Professor in Obstetrics, King’s College London
Jenny Chambers: PPI Representative
Dr. Peter Dixon: Research Fellow, King’s College London
Associate Professor Jon Dorling: Clinical Associate Professor in Neonatology, University of Nottingham
Rachael Hunter: Senior Research Associate, Royal Free Medical School, London
Professor Jim Thornton: Professor of Obstetrics and Gynaecology, City Hospital, Nottingham
Professor Catherine Williamson: Professor of Women’s Health, King’s College London
Ursula Bowler: Senior Trials Manager National Perinatal Epidemiology Unit Clinical Trials Unit, University of Oxford, Oxford
Associate Professor Edmund Juszczak: National Perinatal Epidemiology Unit Clinical Trials Unit Director, University of Oxford, Oxford
Trial steering Committee:
The trial will be overseen by a Trial Steering Committee consisting of an independent chair and at least two other independent members who will meet at least annually.
Independent members:
Dr. David Williams (Chair): Consultant Obstetric Physician, University College London Hospital
Dr. Julia Sanders: Consultant Midwife and Professor of Midwifery, Cardiff University School of Medicine
Professor Win Tin: Professor of Paediatric and Neonatal Medicine, James Cook University Hospital, Middlesbrough
Professor Deborah Stocken: Director, Comprehensive Health Research Division, Clinical Trials Research Unit, University of Leeds
Miss Judith Hibbert: PPI Representative, London
Professor Julian Walters: Professor of Gastroenterology, Hammersmith Hospital, London
Non-independent members:
Professor Lucy Chappell: NIHR Research Professor of Obstetrics. King’s College London
Associate Professor Edmund Juszczak: National Perinatal Epidemiology Unit Clinical Trials Unit Director, University of Oxford, Oxford
Data Monitoring Committee:
A Data Monitoring Committee, independent of the applicants and of the Trial Steering Committee will review the progress of the trial at least annually and provide advice on the conduct of the trial to the Trial Steering Committee and to the funder. A charter has been completed following the recommendations of the DAMOCLES Study [
18]. The committee will periodically review trial progress and outcomes and will look regularly at protocol adherence by site and by trial arm, including randomisation processes and patterns of allocation. In the light of interim data on the trial’s outcomes, adverse event data, accumulating evidence from other trials and any other relevant evidence, the Data Monitoring Committee will inform the Trial Steering Committee if in their view there is proof beyond reasonable doubt that the data indicate that any part of the protocol under investigation is either clearly indicated or contra-indicated, either for all infants or for a particular subgroup of trial participants and the trial should be terminated. Appropriate proof beyond reasonable doubt cannot be specified precisely. A difference of at least 3 standard errors in the interim analysis of a major endpoint may be needed to justify halting or modifying the trial prematurely, for the superiority hypothesis.
Professor John Norrie (Chair): Director Clinical Trials Unit, Health Services Research Unit, University of Edinburgh
Professor William McGuire: Professor of Child Health, The Hull York Medical School, York
Dr. Jenny Myers: NIHR Clinician Scientist/Clinical Senior Lecturer, University of Manchester