Actively Recruiting

Age: 0 - 30Weeks
All Genders
NCT07192393

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

Age: 0 - 30Weeks
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Preterm birth less than 30 gestational weeks
Not Eligible

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

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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

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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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