PREM-IMPACT is a UK-based observational study exploring how caring for a very premature baby-particularly one affected by necrotising enterocolitis (NEC)-impacts families over the first year after hospital discharge. NEC is a serious bowel disease that can occur in premature babies, often requiring surgery and prolonged hospitalisation.
This study runs alongside the WHEAT International Trial, which investigates whether pausing or continuing milk feeds during blood transfusions affects the risk of NEC in very preterm babies. PREM-IMPACT acts as a nested economic evaluation of the WHEAT Trial, helping to understand whether different feeding practices around transfusion offer good value for money from both the NHS and family perspective.
PREM-IMPACT will collect detailed data on babies' health-related quality of life, as well as the financial, emotional, and social impact on parents and siblings. Families are recruited from neonatal units when their baby is ready to go home and complete questionnaires at three timepoints: 1) just before discharge, 2) six months later, and 3) twelve months later. Questionnaires cover health, wellbeing, healthcare use, and costs to the family (such as travel, time off work, or extra care needs). A dedicated research nurse based at the lead NHS site helps coordinate follow-up centrally.
By studying families of babies with and without NEC, this project aims to clarify the burden of prematurity and NEC on infant outcomes and family wellbeing. The results will inform future policy decisions, including whether pausing or continuing milk feeds during transfusion should be adopted in routine neonatal care.
Preterm birth <30 gestational weeks
Parent(s) of a preterm baby who died of necrotising enterocolitis (NEC)
Parent(s) unwilling or unable to provide written informed consent
Parent(s) and sibling(s) unable to understand English.
Parents of 90 babies will be recruited. We have identified at least 9 high-volume recruiting sites for the WHEAT International trial, including 3 regional neonatal surgical units. These sites collectively care for over 300 eligible babies and over 100 babies with NEC annually. Our site selection ensures a diverse sample of parents, representing various socioeconomic and ethnic backgrounds, with all sites located in areas of both affluence and deprivation.
Cohort
Prospective
Not listed
Infant Health-Related Quality of Life (HRQoL)
Parent-reported proxy measure of infant HRQoL using the EQ-TIPS questionnaire, completed at discharge, 6 months, and 12 months post-discharge.
Infant Healthcare Resource Utilisation
Number and type of healthcare services used by the infant over the first year following neonatal discharge, including hospital readmissions, outpatient visits, emergency visits, primary care, and additional medical interventions related to NEC or prematurity.
Household Financial Impact
Out-of-pocket costs, time off work, and financial strain experienced by parents or caregivers, captured using a study-specific questionnaire at 6 and 12 months.
Parental Health-Related Quality of Life
Self-reported HRQoL of parents using EQ-5D-5L at three timepoints.
Parental Wellbeing Capabilities
Self-reported wellbeing scores using EQ-HWB instruments
Sibling Health-Related Quality of Life (EQ-TIPS, ages 0-3)
Proxy-reported HRQoL of siblings aged 0-3 years using the EQ-TIPS instrument.
Economic Evaluation of the WHEAT International Trial
Cost-effectiveness analysis (CEA) of continue vs pause feeds during routine packed red cell transfusion. Summary of cost and utilities collected from this study, to clinical effectiveness from matched participants (babies) enrolled in the WHEAT international trial.
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Imperial College London
Lead sponsor
University of Oxford
Collaborator
University of Leeds
Collaborator
University of Cape Town
Collaborator
