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

Summary

This multi-center, randomized clinical trial compared different bilirubin levels as thresholds for timing of phototherapy in extremely low birth weight infants. The primary hypothesis was that there would be no difference in death or neurodevelopmental impairment at 18-22 months corrected age in infants treated by either aggressive or conservative threshold limits. 1,978 infants were enrolled.

Conditions

• Hyperbilirubinemia, Neonatal
• Jaundice, Neonatal
• Infant, Newborn
• Infant, Low Birth Weight
• Infant, Small for Gestational Age
• Infant, 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.

Sponsors & Collaborators

• National Center for Research Resources (NCRR)

  collaborator NIH

• NICHD Neonatal Research Network

  lead NETWORK

Principal Investigators

• Abbot R. Laptook, MD · Brown University, Women & Infants Hospital of Rhode Island

• Michele C. Walsh, MD MS · Case Western Reserve University, Rainbow Babies and Children's Hospital

• Ronald N. Goldberg, MD · Duke University

• Brenda B. Poindexter, MD MS · Indiana University

• Abhik Das, PhD · RTI International

• Ronnie Guillet, MD PhD · University of Rochester

• Pablo J. Sanchez, MD · University of Texas, Southwestern Medical Center at Dallas

• Barbara J. Stoll, MD · Emory University

• Krisa P. Van Meurs, MD · Stanford University

• Neil N. Finer, MD · University of California, San Diego

• Kurt Schibler, MD · Children's Hospital Medical Center, Cincinnati

• Waldemar A. Carlo, MD · University of Alabama at Birmingham

• Brenda H. Morris, MD · The University of Texas Health Science Center, Houston

• Seetha Shankaran, MD · Wayne State University

• Richard A. Ehrenkranz, MD · Yale University

• Shahnaz Duara, MD · University of Miami

• T. Michael O'Shea, MD MPH · Wake Forest University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

12 Hours

Max Age

36 Hours

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2002-09-30

Primary Completion

2005-04-30

Completion

2007-11-30

Countries

• United States

Study Locations