Prediction of Jaundice in Term Infants

Completed

• Conditions: Jaundice; Infant, Newborn

• Registration Number: NCT01203410
• Lead Sponsor: NICHD Neonatal Research Network

Brief Summary

The objective of this study was to describe total bilirubin production in healthy term infants as a means of understanding the differences in jaundice pigment production associated with various common clinical circumstances.

Detailed Description

Jaundice occurs in most human neonates during the several days after birth. The objective of this study was to describe total bilirubin production in healthy term infants as a means of understanding the differences in jaundice pigment production associated with various common clinical circumstances.

Study Timeline

• Study Start: 1991-11
• Primary Completion: 1992-11
• Study Completion: 1992-11
• Study First Submitted: 2010-09-15
• Study First Submitted QC: 2010-09-15
• Study First Posted: 2010-09-16
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-20
• Last Update Posted: 2019-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 535

Inclusion Criteria

• Infants born via cesarean delivery (to ensure subjects would still be hospitalized and available for ETCOc measurement and blood sampling on day 3 postpartum)
• Delivery within each center's scheduled recruitment period (to maximize nursing availability and minimize cost)
• Birth weight >2500 g
• Gestational age >37 weeks

Exclusion Criteria

• Any illness that would require admission to the neonatal intensive-care unit (NICU) within 8 hours of birth

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
End-tidal carbon End-tidal carbon monoxide levels corrected for ambient air (ETCOc)	2-8 hours of age	An index of bilirubin production

Trial Locations

Locations (13)

Yale University; 🇺🇸 New Haven, Connecticut, United States

George Washington University; 🇺🇸 Washington, District of Columbia, United States

University of New Mexico; 🇺🇸 Albuquerque, New Mexico, United States

University of Tennessee; 🇺🇸 Memphis, Tennessee, United States

University of Miami; 🇺🇸 Miami, Florida, United States

Case Western Reserve University, Rainbow Babies and Children's Hospital; 🇺🇸 Cleveland, Ohio, United States

University of Texas Southwestern Medical Center at Dallas; 🇺🇸 Dallas, Texas, United States

Brown University, Women & Infants Hospital of Rhode Island; 🇺🇸 Providence, Rhode Island, United States

Stanford University; 🇺🇸 Palo Alto, California, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

Wayne State University; 🇺🇸 Detroit, Michigan, United States

Cincinnati Children's Medical Center; 🇺🇸 Cincinnati, Ohio, United States

Indiana University; 🇺🇸 Indianapolis, Indiana, United States