Actively Recruiting
Health-Related Quality-of-Life and Household Financial and Wellbeing Impacts of Prematurity and Necrotising Enterocolitis (NEC).
Led by Imperial College London · Updated on 2026-03-30
90
Participants Needed
7
Research Sites
116 weeks
Total Duration
On this page
Sponsors
I
Imperial College London
Lead Sponsor
U
University of Oxford
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Health-Related Quality-of-Life and Household Financial and Wellbeing Impacts of Prematurity and Necrotising Enterocolitis (NEC).
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Preterm birth less than 30 gestational weeks
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Norfolk and Norwich University Hospital
Norwich, Norfolk, United Kingdom
Actively Recruiting
2
University Hospital Coventry
Coventry, United Kingdom
Actively Recruiting
3
Liverpool Women's Hospital
Liverpool, United Kingdom
Actively Recruiting
4
Chelsea & Westminster Hospital
London, United Kingdom
Actively Recruiting
5
Imperial College Healthcare NHS Trust (St Mary's Hospital, Paddington)
London, United Kingdom
Actively Recruiting
6
John Radcliffe Hospital
Oxford, United Kingdom
Actively Recruiting
7
Queen Alexandra Hospital
Portsmouth, United Kingdom
Actively Recruiting
Research Team
J
Joe Montebello, MSc
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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