NCT07192393 Health-Related Quality-of-Life and Household Financial and Wellbeing Impacts of Prematurity and Necrotising Enterocolitis (NEC).
| NCT ID | NCT07192393 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Imperial College London |
| Condition | Prematurity; Extreme |
| Study Type | OBSERVATIONAL |
| Enrollment | 90 participants |
| Start Date | 2025-08-08 |
| Primary Completion | 2027-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 90 participants in total. It began in 2025-08-08 with a primary completion date of 2027-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * Preterm birth \<30 gestational weeks Exclusion Criteria: * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07192393 clinical trial?
This trial is open to participants of all sexes, up to 30 Weeks, studying Prematurity; Extreme. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07192393 currently recruiting?
Yes, NCT07192393 is actively recruiting participants. Contact the research team at j.montebello@imperial.ac.uk for enrollment information.
Where is the NCT07192393 trial being conducted?
This trial is being conducted at Norwich, United Kingdom, Coventry, United Kingdom, Liverpool, United Kingdom, London, United Kingdom and 3 additional locations.
Who is sponsoring the NCT07192393 clinical trial?
NCT07192393 is sponsored by Imperial College London. The trial plans to enroll 90 participants.