Health-Related Quality-of-Life and Household Financial and Wellbeing Impacts of Prematurity and Necrotising Enterocolitis (NEC).

Sponsor
Imperial College London
Study ID
NCT07192393
Status
Recruiting
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Conditions

  • Necrotising Enterocolitis
  • Prematurity; Decision Support
  • Prematurity; Extreme
  • Preterm
  • Preterm Birth
  • Preterm Infant Health

Eligibility Criteria

Sex
ALL
Age
N/A - 30 Weeks
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
Sep 25, 2025
Start date
Aug 8, 2025
Status verified
Mar 2026
Primary completion
Oct 31, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
90 participants (estimated)

Arms

  • Arm: General Prematurity
    Includes all babies born \<30 weeks gestation, who did not develop NEC during their hospital stay, and their parents and siblings.
  • Arm: 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.

Primary Outcome Measure

Infant Health-Related Quality of Life (HRQoL) [ Time Frame: Baseline (at the point of discharge home from neonatal care), 6 months post-neonatal discharge, and 12 months post-neonatal discharge. ]

Central Contacts

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