Prediction of Neonatal Hyperbilirubinemia

NCT01109277 | Completed

• 1 other identifier: 2010ICTPAGR
• Study Type: observational
• Target: 3,500
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Hyperbilirubinemia, Neonatal

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Healthy term and late-preterm neonates

Eligibility Criteria

• Age: 1 Hour - 15 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Healthy term and late-preterm neonates

You may qualify if:

• Healthy term and late-preterm neonates

You may not qualify if:

• Admission to the NICU

Sponsors & Collaborators

• University of Patras: lead

Study Sites (1)

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

Pátrai, 26504, Greece

Location

MeSH Terms

Conditions

Hyperbilirubinemia, Neonatal

Condition Hierarchy (Ancestors)

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

Study Officials

• Anastasia Varvarigou, Prof

  Neonatal Intensive Care Unit, Department of Pediatrics, University Hospital of Patras

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 21, 2010
• First Posted: April 23, 2010
• Study Start: April 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: January 19, 2011

Record last verified: 2010-04

Locations

GR (1)