Title: Improving quality of care and outcome at very preterm birth
Funder: Department of Health (England)

Abstract: Aims are to improve the quality of immediate care at preterm birth, enhance family-centred care, and improve outcome for infants and their families. OBJECTIVES are to: 1. Identify and prioritise treatment uncertainties for preterm birth 2. Develop strategies for providing initial care at birth at the bedside for preterm babies 2.1 conduct a survey of practice 2.2 assess parents views of initial care at the bedside 2.3 improve understanding of the physiology of transition from fetal to neonatal circulation 2.4 systematically review strategies for initial care and assessment 2.5 develop a mobile newborn life support trolley 3. Generate the information to enable conduct of a large NHS trial comparing deferred cord clamping and initial care at the bedside, with immediate clamping and initial care at the side of the room, for preterm births 3.1 develop the protocol for a prospective meta-analysis of such trials 3.2 systematically review ethical issues in recruiting preterm or sick infants to trials 3.3 determine the best decision analytical model to inform trial design 3.4 conduct a feasibility pilot trial BACKGROUND Preterm birth is the most important single determinant of adverse infant outcome in terms of: survival; quality of life; psychosocial and emotional impact on the family; and costs for health services. The research agenda has been determined primarily by researchers, and processes for priority setting in research often lack transparency. The James Lind Alliance has developed methods for establishing Priority Setting Partnerships between clinician organisations and patient organisations, which then identify and prioritise treatment uncertainties in order to inform publicly funded research. At birth, preterm babies are usually taken to a resuscitaire at the side of the room. Providing initial care at the bedside would be more family-centred. Our proposal is to develop strategies for providing initial care and assessment at the bedside, and assess their feasibilty and their acceptablity to parents and to clinciains. Family presence has been developed in adult resuscitation; it is preferred by families, and is now in national guidelines. Experience in neonatal units suggests that whilst parents value being involved in their child’s care, some prefer not to be present during procedures on their baby. Providing initial care at the bedside would make it feasible to defer umbilical cord clamping. There is promising evidence from a Cochrane review that deferring cord clamping to allow placental transfusion for preterm births may be beneficial compared to immediate clamping. To assess whether it would be feasible to conduct a large NHS randomised trial requires a pilot study. Providing really reliable data on disability-free survival, a key outcome, requires very large numbers. To achieve this requires international collaboration, for example in a prospective meta-analysis. RESEARCH PLAN The programme has six interconnected Work Packages: 1. Identifying and prioritising research gaps for preterm birth: a James Lind Alliance Priority Setting Partnership 2. Systematic reviews 2.1 initial care and stabilisation with cord intact 2.2 ethical issues in recruitment of preterm or sick infants to trials 3. Developing strategies for providing initial care at the bedside 3.1 survey of current practice 3.2 assessing parents' views 3.3 measuring how placental transfusion varies with gestation 3.4 developing a Bedside Assessment, Stabilisation and Initial Circulatory Support (BASICS) trolley 3.5 evaluating BASICS trolley 4. Pilot randomised trial of deferred cord clamping and initial care at the bedside for preterm births 5. Prospective meta-analysis 6. Economic analysis RESEARCH TEAM AND ENVIRONMENT We have assembled a strong multi-disciplinary team with established experts in all areas of our proposed research, including service user involvement in research, Priority Setting Partnerships, perinatal trials, systematic reviews, clinical expertise, service users, medical ethics, health policy, economics, statistics, prospective meta-analysis, qualitative methods, and NHS management. The trial will be supported by a registered clinical trials unit. Applicants are based in successful research units. The proposal has been developed in partnership with representatives of the National Childbirth Trust and Bliss, who will contribute to all aspects of the programme. OUTPUTS Top 10 research priorities for preterm birth, clinical guidance for initial care at the bedside, change in practice, BASICS, understanding parents' views, papers in peer reviewed journals, presentation at conferences (including INVOLVE, National Childbirth Trust, and Bliss), articles in lay media, a PhD, and demonstrated feasibilty of a large RCT. JUSTIFICATION OF RESOURCES This complex multi-disciplinary programme of work requires strong management, service user input, a clinical trials unit and dedicated research time.


Research activity codes: 8.1 ORGANISATION AND DELIVERY OF SERVICES;8.3 POLICY, ETHICS AND RESEARCH GOVERNANCE
Health categories: REPRODUCTIVE HEALTH AND CHILDBIRTH