Health-Related Quality-of-Life and Household Financial and Wellbeing Impacts of Prematurity and Necrotising Enterocolitis (NEC).
NCT ID: NCT07192393
Last Updated: 2025-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
90 participants
OBSERVATIONAL
2025-08-08
2027-10-31
Brief Summary
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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.
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Detailed Description
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Background Necrotising enterocolitis (NEC) is a severe gastrointestinal condition affecting very preterm infants, associated with high mortality and significant long-term morbidity. Despite progress in neonatal care, NEC remains a major contributor to healthcare burden and family distress. The WHEAT International Trial is evaluating whether pausing vs continuing enteral feeds during packed red cell transfusion influences NEC incidence in very preterm infants. However, an economic evaluation was not built into WHEAT due to funding limitations.
Study Design PREM-IMPACT is a prospective, observational cohort study embedded within UK sites participating in the WHEAT Trial. Its aim is to quantify the household and health system impacts associated with NEC and evaluate the cost-effectiveness of feeding practices during transfusion. This includes examining infant health-related quality of life (HRQoL), parental and sibling wellbeing, healthcare resource use, and economic burden to families and the NHS.
Recruitment A minimum of 75 families of babies born at \<30 weeks' gestation will be recruited from neonatal units across 5-7 NHS hospitals. Families will be stratified by NEC diagnosis (NEC vs no NEC). Data collection occurs at three timepoints: baseline (just prior to neonatal discharge), 6 months post-discharge, and 12 months post-discharge.
Data
Data collected in the study include:
* Infant clinical information (birth, diagnoses, feeding method, length of stay)
* Parental and sibling demographics
* Infant HRQoL (EQ-TIPS, parent proxy)
* Parent HRQoL and wellbeing (EQ-5D-5L, EQ-HWB, ICECAP-A)
* Sibling HRQoL (EQ-TIPS or EQ-5D-Y, depending on age)
* Financial impact (out-of-pocket expenses, income loss, employment changes)
* Healthcare utilisation (readmissions, outpatient visits, GP visits, therapies)
Analyses Descriptive and comparative analyses will explore group differences in costs and outcomes. Quality-adjusted life years (QALYs) will be derived for each family member using appropriate value sets. A cost-consequence analysis will be performed to assess the overall burden of NEC. In addition, cost and utility data collected in PREM-IMPACT will be combined with clinical effectiveness data from infants enrolled in the WHEAT International Trial to conduct a model-based cost-effectiveness analysis (CEA) of feeding practices during transfusion. The CEA will adopt both NHS and societal perspectives.
Impact This study addresses a critical evidence gap by capturing the broader health and financial consequences of NEC and prematurity across the family unit. Findings will inform future resource allocation and neonatal care policy decisions.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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General Prematurity
Includes all babies born \<30 weeks gestation, who did not develop NEC during their hospital stay, and their parents and siblings.
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Parent(s) unwilling or unable to provide written informed consent
* Parent(s) and sibling(s) unable to understand English.
30 Weeks
ALL
No
Sponsors
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University of Oxford
OTHER
University of Leeds
OTHER
University of Cape Town
OTHER
Imperial College London
OTHER
Responsible Party
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Locations
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University Hospital Coventry
Coventry, , United Kingdom
Liverpool Women's Hospital
Liverpool, , United Kingdom
Chelsea & Westminster Hospital
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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351166
Identifier Type: -
Identifier Source: org_study_id
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