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.

Study Overview

• Status: Completed
• Conditions: Jaundice; Infant, Newborn

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 Type: Observational
• Enrollment (Actual): 535

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 8 hours (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Term infants.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
End-tidal carbon End-tidal carbon monoxide levels corrected for ambient air (ETCOc)	An index of bilirubin production	2-8 hours of age

Collaborators and Investigators

• Sponsor: NICHD Neonatal Research Network
• Investigators: Study Director: David K. Stevenson, MD, Stanford University

Publications and helpful links

General Publications

• 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.

Helpful Links

• NICHD Neonatal Research Network

Study record dates

Study Major Dates

• Study Start: November 1, 1991
• Primary Completion (Actual): November 1, 1992
• Study Completion (Actual): November 1, 1992

Study Registration Dates

• First Submitted: September 15, 2010
• First Submitted That Met QC Criteria: September 15, 2010
• First Posted (Estimate): September 16, 2010

Study Record Updates

• Last Update Posted (Actual): March 22, 2019
• Last Update Submitted That Met QC Criteria: March 20, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Hyperbilirubinemia; NICHD Neonatal Research Network; Term infant
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Manifestations; Hyperbilirubinemia; Jaundice
• Other Study ID Numbers: NICHD-NRN-0004; U10HD021364 (U.S. NIH Grant/Contract); U10HD021373 (U.S. NIH Grant/Contract); U10HD021385 (U.S. NIH Grant/Contract); U10HD027851 (U.S. NIH Grant/Contract); U10HD027853 (U.S. NIH Grant/Contract); U10HD027856 (U.S. NIH Grant/Contract); U10HD027871 (U.S. NIH Grant/Contract); U10HD027880 (U.S. NIH Grant/Contract); U10HD027904 (U.S. NIH Grant/Contract); U01HD019897 (U.S. NIH Grant/Contract); U10HD021415 (U.S. NIH Grant/Contract); U10HD027881 (U.S. NIH Grant/Contract)