Clinical trial NCT01203410: Prediction of Jaundice in Term Infants
Official title: BilirubinProduction in Healthy Term Infants as Measured by Carbon Monoxide in Breath
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infant, Newborn
Jaundice
Keywords: NICHD Neonatal Research Network
Term infant
Hyperbilirubinemia
Lead sponsor: NICHD Neonatal Research Network
Sponsor class: NETWORK
First posted: 2010-09-16
Enrollment: 535
Sex: ALL
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Term infants.

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.

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 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

Primary outcomes:
measure: End-tidal carbon End-tidal carbon monoxide levels corrected for ambient air (ETCOc)
timeFrame: 2-8 hours of age
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Washington
country: United States
facility: George Washington University
state: District of Columbia
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
city: Cincinnati
country: United States
facility: Cincinnati Children's Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Case Western Reserve University, Rainbow Babies and Children's Hospital
state: Ohio
city: Providence
country: United States
facility: Brown University, Women & Infants Hospital of Rhode Island
state: Rhode Island
city: Memphis
country: United States
facility: University of Tennessee
state: Tennessee
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center at Dallas
state: Texas
Study officials:
affiliation: Stanford University
name: David K. Stevenson, MD
role: STUDY_DIRECTOR
affiliation: Brown University, Women & Infants Hospital of Rhode Island
name: William Oh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Case Western Reserve University
name: Avroy A. Fanaroff, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Indiana University
name: James A. Lemons, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: George Washington University
name: Raymond Bain, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wayne State University
name: Seetha Shankaran, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas
name: Jon E. Tyson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Tennessee
name: Sheldon B. Korones, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Miami
name: Charles R. Bauer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Barbara J. Stoll, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of New Mexico
name: Lu-Ann Papile, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital Medical Center, Cincinnati
name: Edward F. Donovan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Richard A. Ehrenkranz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.