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

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.

• Parental Health-Related Quality of Life [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 [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) [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 [Time frame: From study start through study completion, approximately 2 years.]
• Parental Wellbeing Capabilities [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) [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+) [Time frame: Baseline (at the point of discharge home from neonatal care), 6 months post-neonatal discharge, and 12 months post-neonatal discharge.]