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

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Sponsor:

Information provided by:

NICHD Neonatal Research Network

Study Description

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.

Study Design

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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

Groups and Cohorts

Group/Cohort
Cohort 1 Term infants >2500g birthweight.

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

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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.

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

Contacts and Locations

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

Locations

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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

Investigators

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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

More Information

Additional Information:

NICHD Neonatal Research Network This link exits the ClinicalTrials.gov site

Publications of Results:

Vreman HJ, Stevenson DK, Oh W, Fanaroff AA, Wright LL, Lemons JA, Wright E, Shankaran S, Tyson JE, Korones SB, et al. Semiportable electrochemical instrument for determining carbon monoxide in breath. Clin Chem. 1994 Oct;40(10):1927-33.

Stevenson DK, Vreman HJ, Oh W, Fanaroff AA, Wright LL, Lemons JA, Verter J, Shankaran S, Tyson JE, Korones SB, et al. Bilirubin production in healthy term infants as measured by carbon monoxide in breath. Clin Chem. 1994 Oct;40(10):1934-9.

Vreman HJ, Verter J, Oh W, Fanaroff AA, Wright LL, Lemons JA, Shankaran S, Tyson JE, Korones SB, Bauer CR, Stoll BJ, Papile LA, Donovan EF, Ehrenkranz RA, Stevenson DK. Interlaboratory variability of bilirubin measurements. Clin Chem. 1996 Jun;42(6 Pt 1):869-73.

Hintz SR, Gaylord TD, Oh W, Fanaroff AA, Mele L, Stevenson DK, Nichd FT; NICHD, Neonatal Research Network. Serum bilirubin levels at 72 hours by selected characteristics in breastfed and formula-fed term infants delivered by cesarean section. Acta Paediatr. 2001 Jul;90(7):776-81.

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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 Hyperbilirubinemia

Additional relevant MeSH terms:

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Jaundice Hyperbilirubinemia Pathologic Processes Skin Manifestations

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