Health-Related Quality-of-Life and Household Financial and Wellbeing Impacts of Prematurity and Necrotising Enterocolitis (NEC).

NCT07192393 | Recruiting

• 1 other identifier: 351166
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 7

Brief 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. 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.

Conditions

Prematurity; Extreme; Necrotising Enterocolitis; Preterm; Preterm Birth; Preterm Infant Health; Prematurity; Decision Support

Keywords

NEC; Cost-Effectiveness Analysis; Cost-Utility Analysis; Health-Related Quality of Life; HR-QoL; Prematurity; Preterm; Health Economic Analysis; Financial Impact; Wellbeing

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  At 6 months post-neonatal discharge and 12 months post-neonatal discharge.

Secondary Outcomes (7)

• Parental Health-Related Quality of Life

  Baseline (at the point of discharge home from neonatal care), 6 months post-neonatal discharge, and 12 months post-neonatal discharge.

• Parental Wellbeing Capabilities

  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)

  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

  From study start through study completion, approximately 2 years.

• Parental Wellbeing Capabilities

  Baseline (at the point of discharge home from neonatal care), 6 months post-neonatal discharge, and 12 months post-neonatal discharge.

Study Arms (2)

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.

Eligibility Criteria

• Age: Up to 30 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Preterm birth \<30 gestational weeks

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oxford: collaborator
• University of Leeds: collaborator
• University of Cape Town: collaborator
• Imperial College London: lead

Study Sites (7)

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

MeSH Terms

Conditions

Premature Birth; Enterocolitis, Necrotizing

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Central Study Contacts

Joe Montebello, MSc

CONTACT

+442075947271; j.montebello@imperial.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: September 25, 2025
• Study Start: August 8, 2025
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (7)