An observational study in Prematurity; Extreme, Prematurity; Decision Support and Necrotising Enterocolitis, sponsored by Imperial College London. Recruiting at 7 sites in United Kingdom. Open to participants aged Up to 30 Weeks. Per ClinicalTrials.gov, last updated 2026-03-30.
Sponsored by Imperial College London · Observational
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.
PREM-IMPACT (PREMaturity IMPACT): 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 WHEAT Trial
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:
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.
2,550 studies on the registry are indexed under Premature Birth; 500 are open to participants now.
This study's planned enrollment of 90 is below the median of 120 across 806 observational studies indexed under Premature Birth.
Browse Premature Birth studies →Imperial College London is the lead sponsor of 843 studies on the registry; 180 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Parents of 90 babies will be recruited.
We have identified at least 9 high-volume recruiting sites for the WHEAT International trial, including 3 regional neonatal surgical units. These sites collectively care for over 300 eligible babies and over 100 babies with NEC annually. Our site selection ensures a diverse sample of parents, representing various socioeconomic and ethnic backgrounds, with all sites located in areas of both affluence and deprivation.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Includes all babies born \<30 weeks gestation, who did not develop NEC during their hospital stay, and their parents and siblings.
Includes all babies born \<30 weeks gestation, who also developed and recovered from NEC during their hospital stay, and their parents and siblings.
Infant Health-Related Quality of Life (HRQoL)
Parent-reported proxy measure of infant HRQoL using the EQ-TIPS questionnaire, completed at discharge, 6 months, and 12 months post-discharge.
Time frame: Baseline (at the point of discharge home from neonatal care), 6 months post-neonatal discharge, and 12 months post-neonatal discharge.
Infant Healthcare Resource Utilisation
Number and type of healthcare services used by the infant over the first year following neonatal discharge, including hospital readmissions, outpatient visits, emergency visits, primary care, and additional medical interventions related to NEC or prematurity.
Time frame: At 6 months post-neonatal discharge and 12 months post-neonatal discharge.
Household Financial Impact
Out-of-pocket costs, time off work, and financial strain experienced by parents or caregivers, captured using a study-specific questionnaire at 6 and 12 months.
Time frame: At 6 months post-neonatal discharge and 12 months post-neonatal discharge.
Parental Health-Related Quality of Life
Self-reported HRQoL of parents using EQ-5D-5L at three timepoints.
Time frame: Baseline (at the point of discharge home from neonatal care), 6 months post-neonatal discharge, and 12 months post-neonatal discharge.
Parental Wellbeing Capabilities
Self-reported wellbeing scores using EQ-HWB instruments
Time frame: Baseline (at the point of discharge home from neonatal care), 6 months post-neonatal discharge, and 12 months post-neonatal discharge.
Sibling Health-Related Quality of Life (EQ-TIPS, ages 0-3)
Proxy-reported HRQoL of siblings aged 0-3 years using the EQ-TIPS instrument.
Time frame: Baseline (at the point of discharge home from neonatal care), 6 months post-neonatal discharge, and 12 months post-neonatal discharge.
Economic Evaluation of the WHEAT International Trial
Cost-effectiveness analysis (CEA) of continue vs pause feeds during routine packed red cell transfusion. Summary of cost and utilities collected from this study, to clinical effectiveness from matched participants (babies) enrolled in the WHEAT international trial.
Time frame: From study start through study completion, approximately 2 years.
Parental Wellbeing Capabilities
Self-reported wellbeing (capability) scores using ICECAP-A instruments.
Time frame: Baseline (at the point of discharge home from neonatal care), 6 months post-neonatal discharge, and 12 months post-neonatal discharge.
Sibling Health-Related Quality of Life (EQ-5D-Y-3L, ages 4-15)
Age-appropriate self- or proxy-reported HRQoL of siblings aged 4-15 years using the EQ-5D-Y-3L instrument.
Time frame: Baseline (at the point of discharge home from neonatal care), 6 months post-neonatal discharge, and 12 months post-neonatal discharge.
Sibling Health-Related Quality of Life (EQ-5D-5L, ages 16+)
Age-appropriate self- or proxy-reported HRQoL of siblings aged 16+ years using the EQ-5D-5L instrument.
Time frame: Baseline (at the point of discharge home from neonatal care), 6 months post-neonatal discharge, and 12 months post-neonatal discharge.
Plan to share: No
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Started Aug 2025 (actual). Primary completion is estimated for Oct 2027, 26 months after the start.
Of 372 non-industry observational studies under Premature Birth, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 63. This study's planned 26 months is below that.
Counting every sponsor, half of 387 studies reached it within 35 months; a quarter within 18 and three quarters within 61.
How these figures are worked out, and which studies are left out of them.
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