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NCT01203410 Clinical Trial

Prediction of Jaundice in Term Infants

Infant, Newborn Clinical Trial

Official title:
BilirubinProduction in Healthy Term Infants as Measured by Carbon Monoxide in Breath

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01203410
Other study ID # NICHD-NRN-0004
Secondary ID U10HD021364U10HD
Status Completed
Phase
First received
Last updated
Start date November 1991
Est. completion date November 1992

Study information
Verified date March 2019
Source NICHD Neonatal Research Network
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 535
Est. completion date November 1992
Est. primary completion date November 1992
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 8 Hours
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of New Mexico Albuquerque New Mexico
United States Emory University Atlanta Georgia
United States Cincinnati Children's Medical Center Cincinnati Ohio
United States Case Western Reserve University, Rainbow Babies and Children's Hospital Cleveland Ohio
United States University of Texas Southwestern Medical Center at Dallas Dallas Texas
United States Wayne State University Detroit Michigan
United States Indiana University Indianapolis Indiana
United States University of Tennessee Memphis Tennessee
United States University of Miami Miami Florida
United States Yale University New Haven Connecticut
United States Stanford University Palo Alto California
United States Brown University, Women & Infants Hospital of Rhode Island Providence Rhode Island
United States George Washington University Washington District of Columbia

Sponsors (1)
Lead Sponsor Collaborator
NICHD Neonatal Research Network

Country where clinical trial is conducted

United States, 

References & Publications (4)

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 Paediat — View 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. — View 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. — View 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): — View Citation

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