Prediction of Jaundice in Term Infants

NCT ID: NCT01203410

Last Updated: 2019-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

535 participants

Study Classification

OBSERVATIONAL

Study Start Date

1991-11-30

Study Completion Date

1992-11-30

Brief Summary

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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

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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.

Conditions

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Infant, Newborn Jaundice

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort 1

Term infants \>2500g birthweight.

No interventions assigned to this group

Eligibility Criteria

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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
Maximum Eligible Age

8 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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NICHD Neonatal Research Network

NETWORK

Sponsor Role lead

Responsible Party

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Stanford University

Principal Investigators

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David K. Stevenson, MD

Role: STUDY_DIRECTOR

Stanford University

William Oh, MD

Role: PRINCIPAL_INVESTIGATOR

Brown University, Women & Infants Hospital of Rhode Island

Avroy A. Fanaroff, MD

Role: PRINCIPAL_INVESTIGATOR

Case Western Reserve University

James A. Lemons, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Raymond Bain, PhD

Role: PRINCIPAL_INVESTIGATOR

George Washington University

Seetha Shankaran, MD

Role: PRINCIPAL_INVESTIGATOR

Wayne State University

Jon E. Tyson, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas

Sheldon B. Korones, MD

Role: PRINCIPAL_INVESTIGATOR

University of Tennessee

Charles R. Bauer, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Barbara J. Stoll, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Lu-Ann Papile, MD

Role: PRINCIPAL_INVESTIGATOR

University of New Mexico

Edward F. Donovan, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Richard A. Ehrenkranz, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Stanford University

Palo Alto, California, United States

Site Status

Yale University

New Haven, Connecticut, United States

Site Status

George Washington University

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

Site Status

University of Miami

Miami, Florida, United States

Site Status

Emory University

Atlanta, Georgia, United States

Site Status

Indiana University

Indianapolis, Indiana, United States

Site Status

Wayne State University

Detroit, Michigan, United States

Site Status

University of New Mexico

Albuquerque, New Mexico, United States

Site Status

Cincinnati Children's Medical Center

Cincinnati, Ohio, United States

Site Status

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

Cleveland, Ohio, United States

Site Status

Brown University, Women & Infants Hospital of Rhode Island

Providence, Rhode Island, United States

Site Status

University of Tennessee

Memphis, Tennessee, United States

Site Status

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 7923774 (View on PubMed)

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.

Reference Type RESULT
PMID: 7923775 (View on PubMed)

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.

Reference Type RESULT
PMID: 8665677 (View on PubMed)

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.

Reference Type RESULT
PMID: 11519981 (View on PubMed)

Related Links

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http://neonatal.rti.org/

NICHD Neonatal Research Network

Other Identifiers

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U10HD021364

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U10HD027853

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U10HD027851

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U01HD019897

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U10HD027856

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U10HD027881

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U10HD027880

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U10HD021415

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U10HD021373

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U10HD021385

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U10HD027904

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U10HD027871

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NICHD-NRN-0004

Identifier Type: -

Identifier Source: org_study_id

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