Prediction of Jaundice in Term Infants

This study has been completed.
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT01203410
First received: September 15, 2010
Last updated: January 9, 2011
Last verified: September 2010
  Purpose

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
Infant, Newborn
Jaundice

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: BilirubinProduction in Healthy Term Infants as Measured by Carbon Monoxide in Breath

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • End-tidal carbon End-tidal carbon monoxide levels corrected for ambient air (ETCOc) [ Time Frame: 2-8 hours of age ] [ Designated as safety issue: Yes ]
    An index of bilirubin production


Enrollment: 535
Study Start Date: November 1991
Study Completion Date: November 1992
Primary Completion Date: November 1992 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cohort 1
Term infants >2500g birthweight.

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.

  Eligibility

Ages Eligible for Study:   up to 8 Hours
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01203410

Locations
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
Investigators
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 Cincinnati Children's Medical Center
Principal Investigator: Richard A. Ehrenkranz, MD Yale University
  More Information

Additional Information:
Publications:
Responsible Party: David K. Stevenson/ Lead Principal Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT01203410     History of Changes
Other Study ID Numbers: NICHD-NRN-0004, U10HD021364, U10HD027853, U10HD027851, U01HD019897, U10HD027856, U10HD021373, U10HD027881, U10HD027880, U10HD021415, U10HD021385, U10HD027904, U10HD027871
Study First Received: September 15, 2010
Last Updated: January 9, 2011
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
NICHD Neonatal Research Network
Term infant
Hyperbilirubinemia

Additional relevant MeSH terms:
Jaundice
Hyperbilirubinemia
Pathologic Processes
Skin Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on July 28, 2014