Prematurity; ExtremePREM-IMPACTNCT07192393
Health-Related Quality-of-Life and Household Financial and Wellbeing Impacts of Prematurity and Necrotising Enterocolitis (NEC).
An observational study of Prematurity; Extreme and Prematurity; Decision Support, run by Imperial College London at 7 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 30 weeks
- Conditions the study is for
- Prematurity; Extreme, Prematurity; Decision Support, Necrotising Enterocolitis
- How many people
- 90 participants
- Where
- 7 sitesUnited Kingdom
- Study dates
- 8 Aug 2025to 31 Oct 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 30 weeks
- All sexes
- No healthy volunteers
- Child
Study population: 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.
Who may be able to join
- Preterm birth <30 gestational weeks
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United Kingdom7 sites, 7 recruiting
- Recruiting
University Hospital Coventry
Coventry
Arthi Lakshmanan, +442476966201, Uhcw.Research5@uhcw.nhs.uk
Arthi Lakshmanan
- Recruiting
Liverpool Women's Hospital
Liverpool
Jo Windrow, +441517024084, joanne.windrow@lwh.nhs.uk
Jo Windrow
- Recruiting
Chelsea & Westminster Hospital
London
Chris Gale, +442033153519, christopher.gale@imperial.ac.uk
Chris Gale
- Recruiting
Imperial College Healthcare NHS Trust (St Mary's Hospital, Paddington)
London
Batia Gourin, 020 3312 6666, b.gourin@nhs.net
Batia Gourin
- Recruiting
Norfolk and Norwich University Hospital
Norwich, Norfolk
Jasmine Myhill, 01603 286286, jasmine.myhill@nnuh.nhs.uk
Jasmine Myhill
- Recruiting
John Radcliffe Hospital
Oxford
Cath Bailey, 0300 304 7777, cath.bailey@ouh.nhs.uk
Cath Bailey
- Recruiting
Queen Alexandra Hospital
Portsmouth
Ali LePoidevin, 023 9228 6000, alison.lepoidevin@porthosp.nhs.uk
Ali LePoidevin
About this study
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
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.
Read more
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.
Read the detailed description
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:
- 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
- Prematurity; Extreme, Prematurity; Decision Support, Necrotising Enterocolitis, Preterm, Preterm Birth, Preterm Infant Health
- Keywords
- NEC, Cost-Effectiveness Analysis, Cost-Utility Analysis, Health-Related Quality of Life, HR-QoL, Prematurity, Preterm, Health Economic Analysis, Financial Impact, Wellbeing
- Medical subject headings
- Premature Birth, Enterocolitis, Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| General Prematurity | Includes all babies born <30 weeks gestation, who did not develop NEC during their hospital stay, and their parents and siblings. | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: At 6 months post-neonatal discharge and 12 months post-neonatal discharge.
Secondary outcomes (7)
Parental Health-Related Quality of Life
Self-reported HRQoL of parents using EQ-5D-5L at three timepoints.
Measured: 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
Measured: 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.
Measured: 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.
Measured: From study start through study completion, approximately 2 years.
Parental Wellbeing Capabilities
Self-reported wellbeing (capability) scores using ICECAP-A instruments.
Measured: 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.
Measured: 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.
Measured: Baseline (at the point of discharge home from neonatal care), 6 months post-neonatal discharge, and 12 months post-neonatal discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start8 Aug 2025
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prematurity; ExtremeStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oxford, University of Leeds, University of Cape Town
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07192393
- Sponsor's protocol ID
- 351166
- Acronym
- PREM-IMPACT
- Status last verified
- Mar 2026
- First submitted
- 9 Sep 2025
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No