DESCRIPTION (provided by applicant): Background: Necrotizing Enterocolitis (NEC) is the most common gastrointestinal emergency for premature infants. It is a costly disease and a primary cause of neonatal morbidity and mortality. Infants with NEC who are managed surgically stay in the Neonatal Intensive Care Unit (NICU) over 90 days on average, are among the most likely to stay more than 6 months and may suffer significant long-term impairments to their bowel, nutrition and cognitive abilities. If NEC symptoms are identified soon enough, feedings can be stopped to limit disease progression and transport to a surgical center facilitated. A risk index may improve early recognition of NEC however none is available. The purpose of this research is to validate a NEC risk index, GUTCHECK, to predict the likelihood of NEC in at-risk neonates to enhance surveillance, recognize NEC while it can be managed medically and decrease failure to rescue. Specific Aims: The specific aims of this research are to: (1) assess the content validity of the GUTCHECK index and (2) test the intra-individual reliability and predictive validity of the index using an existing national perinatal dataset. Significance: Early identification of infants at risk for NEC can lead to fewer surgical interventions, lower morbidity, lower mortality, lower costs, and better resource allocation. Methodology: To achieve Aim 1, an E-Delphi will be used to assess the extent to which experts agree on risk elements in GUTCHECK. To achieve Aim 2, a two stage process of validation using an existing national dataset will determine GUTCHECK's sensitivity and specificity. Intra-individual reliability will be tested using a random sample of cases scored by one observer at two time points. Expected Results: The expected result of this research is an intra-individually reliable, valid and predictive risk index for NEC. Implications for Further Research: Future studies will evaluate the inte-rater reliability of GUTCHECK. Then it will be integrated into a clinical decision support system to integrate risk elements captured from prenatal, maternal, and birth records to provide a risk score in real time. An alert can then be generated if values rise above a preset cut-point. Future studies will measure the effect of using GUTCHECK on early recognition of NEC and improved handoff communication of NEC risk. Relevance to NINR Mission: The development, validation and future integration of GUTCHECK into automated clinical decision support will use technology to translate research into practice at the point of care. In this way, GUTCHECK may improve NEC outcomes by helping clinicians recognize NEC risk and intervene early. PUBLIC HEALTH RELEVANCE: Necrotizing enterocolitis (NEC) is the most common catastrophic gastrointestinal disease that affects newborns, accounting for 3000 deaths a year and nearly one-fifth of neonatal hospital costs in the US. The goal of this study is to validate a risk measure for NEC, GUTCHECK, to help clinicians recognize NEC in its early stages and facilitate appropriate and prompt medical management.
|Effective start/end date||8/10/11 → 5/14/12|
- National Institutes of Health: $31,444.00