Prediction of Jaundice in Term Infants

NCT01203410 | Completed

• 13 other identifiers: NICHD-NRN-0004U10HD021364U10HD027853U10HD027851U01HD019897U10HD027856U10HD027881U10HD027880U10HD021415U10HD021373U10HD021385U10HD027904U10HD027871
• Study Type: observational
• Target: 535
• Locations: 1 country
• Sites: 13

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.

Conditions

Infant, Newborn; Jaundice

Keywords

NICHD Neonatal Research Network; Term infant; Hyperbilirubinemia

Outcome Measures

Primary Outcomes (1)

• End-tidal carbon End-tidal carbon monoxide levels corrected for ambient air (ETCOc)

  An index of bilirubin production

  2-8 hours of age

Study Arms (1)

Cohort 1

Term infants \>2500g birthweight.

Eligibility Criteria

• Age: Up to 8 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Term infants.

You may qualify if:

• 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

You may not qualify if:

• Any illness that would require admission to the neonatal intensive-care unit (NICU) within 8 hours of birth

Sponsors & Collaborators

• NICHD Neonatal Research Network: lead

Study Sites (13)

Stanford University

Palo Alto, California, 94304, United States

Location

Yale University

New Haven, Connecticut, 06504, United States

Location

George Washington University

Washington D.C., District of Columbia, 20052, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Emory University

Atlanta, Georgia, 30303, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Wayne State University

Detroit, Michigan, 48201, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

Cincinnati Children's Medical Center

Cincinnati, Ohio, 45267, United States

Location

Case Western Reserve University, Rainbow Babies and Children's Hospital

Cleveland, Ohio, 44106, United States

Location

Brown University, Women & Infants Hospital of Rhode Island

Providence, Rhode Island, 02905, United States

Location

University of Tennessee

Memphis, Tennessee, 38163, United States

Location

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 75235, United States

Location

Related Publications (4)

• 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.

  PMID: 7923774 RESULT

• 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.

  PMID: 7923775 RESULT

• 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.

  PMID: 8665677 RESULT

• 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.

  PMID: 11519981 RESULT

Related Links

• NICHD Neonatal Research Network

MeSH Terms

Conditions

Jaundice; Hyperbilirubinemia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Officials

• David K. Stevenson, MD

  Stanford University

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: September 15, 2010
• First Posted: September 16, 2010
• Study Start: November 1, 1991
• Primary Completion: November 1, 1992
• Study Completion: November 1, 1992
• Last Updated: March 22, 2019

Record last verified: 2019-03

Locations

US (13)