Prediction of Neonatal Hyperbilirubinemia

Status Completed

Clinical Trial 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 logistic regression analysis Cluster analysis and Chi-squared Automatic Interaction Detection (CHAID) tree method will be used to develop the strategy. At each step, CHAID chooses the independent (predictor) variable that has the strongest interaction with the dependent variable. Categories of each predictor are merged if they are not significantly different with respect to the dependent variable.

Clinical Trial Description

n/a

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01109277
Study type	Observational
Source	University of Patras
Contact
Status	Completed
Phase	N/A
Start date	April 2010
Completion date	January 2011

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Prediction of Neonatal Hyperbilirubinemia — 2010ICTPAGR

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms