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

NCT07192393 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 90

Last updated 2026-03-30

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • University of Oxford

    collaborator OTHER

  • University of Leeds

    collaborator OTHER

  • University of Cape Town

    collaborator OTHER

  • Imperial College London

    lead OTHER

Eligibility

Max Age
30 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-08
Primary Completion
2027-10-31
Completion
2027-10-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07192393 on ClinicalTrials.gov