Household, wellbeing, and quality-of-life impacts of very preterm birth and necrotising enterocolitis
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
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 |
|---|---|
| Enrollment | 90 (estimated) |
| Ages | N/A to 30 Weeks |
| Sex | All |
| Sponsor | Imperial College London Academic / other |
| Locations | 7 sites (Norwich, Norfolk and 6 other locations) |
| Trial ID | NCT07192393 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Norwich, Norfolk and 6 other locations
- 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)
- Queen Alexandra Hospital — Portsmouth, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Joe Montebello, MSc
- Email: j.montebello@imperial.ac.uk
- Phone: +442075947271
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.