Prediction of Jaundice in Term Infants

BilirubinProduction in Healthy Term Infants as Measured by Carbon Monoxide in Breath

Sponsors

Lead Sponsor: NICHD Neonatal Research Network

Source 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.

Overall Status Completed
Start Date November 1991
Completion Date November 1992
Primary Completion Date November 1992
Study Type Observational
Primary Outcome
Measure Time Frame
End-tidal carbon End-tidal carbon monoxide levels corrected for ambient air (ETCOc) 2-8 hours of age
Enrollment 535
Condition
Eligibility

Sampling Method: Probability Sample

Criteria:

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

Gender: All

Minimum Age: N/A

Maximum Age: 8 Hours

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Location
Facility:
Stanford University | Palo Alto, California, 94304, United States
Yale University | New Haven, Connecticut, 06504, United States
George Washington University | Washington, District of Columbia, 20052, United States
University of Miami | Miami, Florida, 33136, United States
Emory University | Atlanta, Georgia, 30303, United States
Indiana University | Indianapolis, Indiana, 46202, United States
Wayne State University | Detroit, Michigan, 48201, United States
University of New Mexico | Albuquerque, New Mexico, 87131, United States
Cincinnati Children's Medical Center | Cincinnati, Ohio, 45267, United States
Case Western Reserve University, Rainbow Babies and Children's Hospital | Cleveland, Ohio, 44106, United States
Brown University, Women & Infants Hospital of Rhode Island | Providence, Rhode Island, 02905, United States
University of Tennessee | Memphis, Tennessee, 38163, United States
University of Texas Southwestern Medical Center at Dallas | Dallas, Texas, 75235, United States
Location Countries

United States

Verification Date

March 2019

Responsible Party

Name Title: David K. Stevenson/ Lead Principal Investigator

Organization: Stanford University

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: Cohort 1

Description: Term infants >2500g birthweight.

Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov