Trial of Aggressive Versus Conservative Phototherapy in Infants <1,000 Grams Birth Weight

PHASE3CompletedINTERVENTIONAL
Enrollment

1,974

Participants

Timeline

Start Date

September 30, 2002

Primary Completion Date

April 30, 2005

Study Completion Date

November 30, 2007

Conditions
Hyperbilirubinemia, NeonatalJaundice, NeonatalInfant, NewbornInfant, Low Birth WeightInfant, Small for Gestational AgeInfant, Premature
Interventions
PROCEDURE

Aggressive Phototherapy 501-750g

Phototherapy started, stopped, and/or restarted when total serum bilirubin levels reach 5 mg/dl during days of life 1-14.

PROCEDURE

Aggressive Phototherapy 751-1000g

Phototherapy started, stopped, and/or restarted when total serum bilirubin levels reach 5 mg/dl during days of life 1-7, and started, stopped, and/or restarted when levels reach 7 mg/dl during days of life 8-14.

PROCEDURE

Conservative Phototherapy 501-750g

Phototherapy started, stopped, and/or restarted when total serum bilirubin levels reach ≥8.0 mg/dl during days of life 1-14.

PROCEDURE

Conservative Phototherapy 751-1000g

Phototherapy started, stopped, and/or restarted when total serum bilirubin levels reach ≥10.0 mg/dl during days of life 1-14.

Trial Locations (17)

14642

University of Rochester, Rochester

27157

Wake Forest University, Charlotte

27705

RTI International, Durham

27710

Duke University, Durham

30303

Emory University, Atlanta

33136

University of Miami, Miami

35233

University of Alabama at Birmingham, Birmingham

44106

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

45267

Cincinnati Children's Medical Center, Cincinnati

46202

Indiana University, Indianapolis

48201

Wayne State University, Detroit

75235

University of Texas Southwestern Medical Center at Dallas, Dallas

77030

University of Texas Health Science Center at Houston, Houston

94304

Stanford University, Palo Alto

92103-8774

University of California at San Diego, San Diego

06504

Yale University, New Haven

02905

Brown University, Women & Infants Hospital of Rhode Island, Providence

All Listed Sponsors
collaborator

National Center for Research Resources (NCRR)

NIH

lead

NICHD Neonatal Research Network

NETWORK

NCT00114543 - Trial of Aggressive Versus Conservative Phototherapy in Infants <1,000 Grams Birth Weight | Biotech Hunter | Biotech Hunter