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Prediction of Jaundice in Term Infants

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ClinicalTrials.gov Identifier: NCT01203410
Recruitment Status : Completed
First Posted : September 16, 2010
Last Update Posted : March 22, 2019
Information provided by:
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.

Condition or disease
Infant, Newborn Jaundice

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.

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Study Type : Observational
Actual Enrollment : 535 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: BilirubinProduction in Healthy Term Infants as Measured by Carbon Monoxide in Breath
Study Start Date : November 1991
Actual Primary Completion Date : November 1992
Actual Study Completion Date : November 1992

Cohort 1
Term infants >2500g birthweight.

Primary Outcome Measures :
  1. End-tidal carbon End-tidal carbon monoxide levels corrected for ambient air (ETCOc) [ Time Frame: 2-8 hours of age ]
    An index of bilirubin production

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 8 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Term infants.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01203410

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United States, California
Stanford University
Palo Alto, California, United States, 94304
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06504
United States, District of Columbia
George Washington University
Washington, District of Columbia, United States, 20052
United States, Florida
University of Miami
Miami, Florida, United States, 33136
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30303
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48201
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131
United States, Ohio
Cincinnati Children's Medical Center
Cincinnati, Ohio, United States, 45267
Case Western Reserve University, Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States, 44106
United States, Rhode Island
Brown University, Women & Infants Hospital of Rhode Island
Providence, Rhode Island, United States, 02905
United States, Tennessee
University of Tennessee
Memphis, Tennessee, United States, 38163
United States, Texas
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75235
Sponsors and Collaborators
NICHD Neonatal Research Network
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Study Director: David K. Stevenson, MD Stanford University
Principal Investigator: William Oh, MD Brown University, Women & Infants Hospital of Rhode Island
Principal Investigator: Avroy A. Fanaroff, MD Case Western Reserve University
Principal Investigator: James A. Lemons, MD Indiana University
Principal Investigator: Raymond Bain, PhD George Washington University
Principal Investigator: Seetha Shankaran, MD Wayne State University
Principal Investigator: Jon E. Tyson, MD University of Texas
Principal Investigator: Sheldon B. Korones, MD University of Tennessee
Principal Investigator: Charles R. Bauer, MD University of Miami
Principal Investigator: Barbara J. Stoll, MD Emory University
Principal Investigator: Lu-Ann Papile, MD University of New Mexico
Principal Investigator: Edward F. Donovan, MD Children's Hospital Medical Center, Cincinnati
Principal Investigator: Richard A. Ehrenkranz, MD Yale University
Additional Information:
Publications of Results:
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Responsible Party: David K. Stevenson/ Lead Principal Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT01203410    
Other Study ID Numbers: NICHD-NRN-0004
U10HD021364 ( U.S. NIH Grant/Contract )
U10HD027853 ( U.S. NIH Grant/Contract )
U10HD027851 ( U.S. NIH Grant/Contract )
U01HD019897 ( U.S. NIH Grant/Contract )
U10HD027856 ( U.S. NIH Grant/Contract )
U10HD027881 ( U.S. NIH Grant/Contract )
U10HD027880 ( U.S. NIH Grant/Contract )
U10HD021415 ( U.S. NIH Grant/Contract )
U10HD021373 ( U.S. NIH Grant/Contract )
U10HD021385 ( U.S. NIH Grant/Contract )
U10HD027904 ( U.S. NIH Grant/Contract )
U10HD027871 ( U.S. NIH Grant/Contract )
First Posted: September 16, 2010    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: March 2019
Keywords provided by NICHD Neonatal Research Network:
NICHD Neonatal Research Network
Term infant
Additional relevant MeSH terms:
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Pathologic Processes
Skin Manifestations