Prediction of Neonatal Hyperbilirubinemia

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.

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Key information

Conditions

Hyperbilirubinemia, Neonatal Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hyperbilirubinemia Infant, Newborn, Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

1 hour–15 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Well-baby nursery, Department of Pediatrics, University Hospital of Patras

Pátrai, 26504, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Healthy term and late-preterm neonates

Exclusion criteria

Admission to the NICU

Treatment and study plan

Primary outcomes

Risk of significant hyperbilirubinemia assessed by an evidence-based strategy

Time frame: Birth to 14th postnatal day

Risk for significant hyperbilirubinemia (defined as serum bilirubin values above the phototherapy threshold according to the American Academy of Pediatrics 2004 guidelines) assessed by a strategy which will combine clinical risk factors and non-invasive TcB measurements

Sponsors and collaborators

Lead sponsor

University of Patras

Other

Registry information

Official study title

An Evidence-based Strategy for Assessing the Risk of Significant Neonatal Hyperbilirubinemia

Acronym: 2010ICTPAGR

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: Apr 23, 2010
Registry last updated: Jan 19, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed