Clinical Trial: Prediction of Neonatal Hyperbilirubinemia
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: An Evidence-based Strategy for Assessing the Risk of Significant Neonatal Hyperbilirubinemia
Brief Summary:
Objective: To develop an evidence-based strategy for assessing the risk of significant hyperbilirubinemia in healthy term and near-term (late-preterm) neonates.
Hypothesis: A stepwise strategy which combines clinical parameters and serial non-invasive transcutaneous bilirubin (TcB) values could reliably predict significant neonatal hyperbilirubinemia.
Methods: Data from neonates >34 weeks' gestation included in the registry for neonatal hyperbilirubinemia of the well-baby nursery of the University Hospital of Patras, from January 2008 to December 2010 will be reviewed.
The registry includes prospectively collected data such as sex, gestational age, gestation and perinatal information, mother's and infant's ABO group and Rh, G6PD deficiency, Coombs test, type of delivery and complications, birthweight, postnatal medications and interventions, type and volume of feeding (daily), extension of jaundice, TcB measurements at intervals of 12+/-4 hours until discharge, total serum bilirubin values (if obtained), TcB or TSB measurements at follow-up, weight at discharge, need of phototherapy (inpatient or after discharge). TcB and TSB values are plotted on a hour-specific chart.
A novel predictive nomogram based on TcB measurements (Varvarigou et al. Pediatrics 2009;124:1052-9) will be used to classify TcB values as high, intermediate, and low risk.
Significant hyperbilirubinemia will be defined as a TSB value above the phototherapy threshold level according to the AAP 2004 guidelines
Statistics: Independent and joint effects of various clinical factors on the development of significant hyperbilirubinemia will be evaluated by logist
Detailed Summary:
Sponsor: University of Patras
Current Primary Outcome: Risk of significant hyperbilirubinemia assessed by an evidence-based strategy [ Time Frame: Birth to 14th postnatal day ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: University of Patras
Dates:
Date Received: April 21, 2010
Date Started: April 2010
Date Completion:
Last Updated: January 18, 2011
Last Verified: April 2010