Household, wellbeing, and quality-of-life impacts of very preterm birth and necrotising enterocolitis
Official title: Quantifying the Household Impact on Patient-Reported Outcomes and Costs Associated With the Care of Preterm Babies With and Without Necrotising Enterocolitis (NEC): A Study Alongside the Withholding Enteral Feeds Around Blood Transfusion (WHEAT) Trial
Run by Imperial College London · NCT07192393 · Data updated 2026-11-12
This project will collect information to see if pausing or continuing milk feeds around blood transfusions relates to babies' quality of life and the financial and emotional impact on families of very preterm infants, especially those with NEC.
Quick facts
| Study type | Observational |
|---|---|
| Ages | Any age to 30 Weeks |
| Sex | All |
| Enrollment | 90 (estimated) |
| Sponsor | Imperial College London Academic / other |
| Locations | 7 sites (Norwich, Norfolk and 6 other locations) |
| Status | Recruiting |
| Started | August 8, 2025 |
| Main results expected | October 31, 2027 |
| Study ends | October 31, 2027 |
| Registry record updated | March 30, 2026 |
| Trial ID | NCT07192393 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal participants are parents of babies born before 30 weeks' gestation who are being discharged from participating UK neonatal units and who can provide informed consent and complete English-language questionnaires.
✕Probably not a fit
Families whose baby died from NEC, those unable to provide written consent, unable to complete English questionnaires, or whose baby was not born before 30 weeks are not expected to benefit from participation in this project.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
PREM-IMPACT is a prospective observational cohort embedded alongside the WHEAT clinical trial at UK neonatal units, recruiting families of babies born before 30 weeks' gestation. Families are enrolled when their baby is ready for discharge and are stratified by whether the infant developed necrotising enterocolitis (NEC) or not. The study will collect infant health-related quality-of-life measures, parental and sibling wellbeing data, and detailed information on healthcare use and household costs at multiple timepoints during the first year after discharge. Data will be used as a nested economic evaluation to compare the household and NHS impacts associated with different feeding practices around transfusion as studied in WHEAT.
Why it matters
Potential benefit: If successful, the findings could clarify the financial, emotional, and health-quality consequences of NEC and feeding practices to inform NHS policy and family support services.
How similar studies have gone: Similar health-related quality-of-life and economic studies have been done in neonatal care with useful but limited and variable results, and combining detailed household impact data with the WHEAT trial clinical question is a novel approach.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Norfolk and Norwich University Hospital
Norwich, Norfolk, United Kingdom Recruiting -
University Hospital Coventry
Coventry, United Kingdom Recruiting -
Liverpool Women's Hospital
Liverpool, United Kingdom Recruiting -
Chelsea & Westminster Hospital
London, United Kingdom Recruiting -
Imperial College Healthcare NHS Trust (St Mary's Hospital, Paddington)
London, United Kingdom Recruiting -
John Radcliffe Hospital
Oxford, United Kingdom Recruiting
Show 1 more location
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Queen Alexandra Hospital
Portsmouth, United Kingdom Recruiting
Study contacts
- Study coordinator: Joe Montebello, MSc
- Email: j.montebello@imperial.ac.uk
- Phone: +442075947271
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.