Quantifying the Household Impact on Patient-Reported Outcomes and Costs Associated With the Care of Preterm Babies With and Without Necrotising Enterocolitis (NEC): A Study Alongside the Withholding Enteral Feeds Around Blood Transfusion (WHEAT) Trial

Status: Recruiting
Location: See all (3) locations...
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 7 months
Healthy Volunteers: f
View:

• Preterm birth \<30 gestational weeks

Locations
Other Locations
United Kingdom
University Hospital Coventry
RECRUITING
Coventry
Liverpool Women's Hospital
RECRUITING
Liverpool
Chelsea & Westminster Hospital
RECRUITING
London
Contact Information
Primary
Joe Montebello, MSc
j.montebello@imperial.ac.uk
+442075947271
Time Frame
Start Date: 2025-08-08
Estimated Completion Date: 2027-10-31
Participants
Target number of participants: 90
Treatments
General Prematurity
Includes all babies born \<30 weeks gestation, who did not develop NEC during their hospital stay, and their parents and siblings.
General Prematurity + Necrotising Enterocolitis (NEC)
Includes all babies born \<30 weeks gestation, who also developed and recovered from NEC during their hospital stay, and their parents and siblings.
Related Therapeutic Areas
Sponsors
Collaborators: University of Leeds, University of Cape Town, University of Oxford
Leads: Imperial College London

This content was sourced from clinicaltrials.gov