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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
History of Changes

September 15, 2010
January 9, 2011
November 1991
November 1992   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01203410 on ClinicalTrials.gov Archive Site
Not Provided
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Prediction of Jaundice in Term Infants
BilirubinProduction in Healthy Term Infants as Measured by Carbon Monoxide in Breath

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.

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Term infants.
  • Infant, Newborn
  • Jaundice
Not Provided
Cohort 1
Term infants >2500g birthweight.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
535
November 1992
November 1992   (final data collection date for primary outcome measure)

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
Both
up to 8 Hours
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01203410
NICHD-NRN-0004, U10HD021364, U10HD027853, U10HD027851, U01HD019897, U10HD027856, U10HD021373, U10HD027881, U10HD027880, U10HD021415, U10HD021385, U10HD027904, U10HD027871
No
David K. Stevenson/ Lead Principal Investigator, Stanford University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Not Provided
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
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP