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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 7
- 主要终点
- Infant Health-Related Quality of Life (HRQoL)
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 30 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm birth <30 gestational weeks
排除标准
- •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.
结局指标
主要结局
Infant Health-Related Quality of Life (HRQoL)
时间窗: Baseline (at the point of discharge home from neonatal care), 6 months post-neonatal discharge, and 12 months post-neonatal discharge.
Parent-reported proxy measure of infant HRQoL using the EQ-TIPS questionnaire, completed at discharge, 6 months, and 12 months post-discharge.
Infant Healthcare Resource Utilisation
时间窗: At 6 months post-neonatal discharge and 12 months post-neonatal discharge.
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.
Household Financial Impact
时间窗: At 6 months post-neonatal discharge and 12 months post-neonatal discharge.
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.
次要结局
- 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.)
- 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.)
- Sibling Health-Related Quality of Life (EQ-5D-Y-3L, ages 4-15)(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+)(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.)