Prediction of Neonatal Hyperbilirubinemia (2010ICTPAGR)

An Evidence-based Strategy for Assessing the Risk of Significant 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.

Study Overview

• Status: Completed
• Conditions: Hyperbilirubinemia, Neonatal

• Study Type: Observational
• Enrollment (Anticipated): 3500

Contacts and Locations

Study Locations

• Greece
  • Patras, Greece, 26504
    • Well-baby nursery, Department of Pediatrics, University Hospital of Patras

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 hour to 2 weeks (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy term and late-preterm neonates

Description

Inclusion Criteria:

• Healthy term and late-preterm neonates

Exclusion Criteria:

• Admission to the NICU

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Healthy term and late-preterm neonates

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk of significant hyperbilirubinemia assessed by an evidence-based strategy	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	Birth to 14th postnatal day

Collaborators and Investigators

• Sponsor: University of Patras
• Investigators: Study Director: Anastasia Varvarigou, Prof, Neonatal Intensive Care Unit, Department of Pediatrics, University Hospital of Patras; Principal Investigator: Sotirios Fouzas, MD, Neonatal Intensive Care Unit, University Hospital of Patras; Principal Investigator: Aggeliki Karatza, MD, Neonatal Intensive Care Unit, University Hospital of Patras; Principal Investigator: Lito Mantagou, MD, Pediatric Department, University Hospital of Patras

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: April 21, 2010
• First Submitted That Met QC Criteria: April 22, 2010
• First Posted (Estimate): April 23, 2010

Study Record Updates

• Last Update Posted (Estimate): January 19, 2011
• Last Update Submitted That Met QC Criteria: January 18, 2011
• Last Verified: April 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infant, Newborn, Diseases; Hyperbilirubinemia; Hyperbilirubinemia, Neonatal
• Other Study ID Numbers: 2010ICTPAGR