Trial of Aggressive Versus Conservative Phototherapy in Infants <1,000 Grams Birth Weight
- Conditions
- Hyperbilirubinemia, NeonatalInfant, Low Birth WeightJaundice, NeonatalInfant, NewbornInfant, Small for Gestational AgeInfant, Premature
- Registration Number
- NCT00114543
- Lead Sponsor
- NICHD Neonatal Research Network
- Brief 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.
- Detailed Description
In NICHD Neonatal Research Network (NRN) centers in 2002, phototherapy was administered to 94 percent of the extremely low birth weight (ELBW) infants who survive more than 12 hours. Yet, it is unclear what level of bilirubin in the blood is harmful for these very tiny infants -- no data existed from large or recent clinical trials to define the risks, benefits, and appropriate indications for phototherapy in these infants. The largest and most recent trial was the NICHD Collaborative Phototherapy Trial which involved infants treated in 1974-1976 and included only 77 ELBW infants. Data from this study and others suggested that phototherapy could have important hazards as well as benefits for ELBW infants.
This NRN study used two different bilirubin levels as thresholds for timing of phototherapy in 1,978 extremely low birth weight infants, examining the primary hypothesis that there would be no difference in death or neurodevelopmental impairment at 18-22 months corrected age between the aggressively and conservatively treated groups.
Enrolled infants were stratified by birth weight (501-750g and 751-1,000g) and randomized to receive phototherapy regimens based on either an aggressive threshold or a conservative threshold of total serum bilirubin.
In the Aggressive group:
* 501-750 grams birth weight infants, phototherapy was started, stopped, and restarted based on a total serum bilirubin threshold level of 5 mg/dl for day of life 1-14.
* 751-1,000 grams birth weight infants, phototherapy was started, stopped, and restarted based on a total serum bilirubin threshold level of 5 mg/dl for day of life 1-7 and 7 mg/dl for day of life 8-14.
In the Conservative group:
* 501-750 grams birth weight infants, phototherapy was started, stopped, and restarted based on a total serum bilirubin threshold level of 8 mg/dl for day of life 1-14.
* 751-1,000 grams birth weight infants, phototherapy was started, stopped, and restarted based on a total serum bilirubin threshold level of 10 mg/dl for day of life 1-14.
The phototherapy regimens are designed to fall within the range of clinical practice and to assure a sizable difference between groups in total serum bilirubin levels and duration of phototherapy.
The primary outcome was death or neurodevelopmental impairment at 18-22 months corrected age determined at an outpatient clinic visit. Secondary outcomes included death, abnormal neurodevelopmental outcome, severe hearing loss, cerebral palsy, blindness, and important medical outcomes.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1974
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Death or neurodevelopmental impairment (MDI <70; PDI <70; cerebral palsy; blindness; or severe hearing loss) 0-22 months corrected age
- Secondary Outcome Measures
Name Time Method Retinopathy of prematurity 36 weeks post conceptual age Intraventricular hemorrhage (IVH) by grade 120 days old or at discharge Periventricular leukomalacia 120 days old or at discharge Hearing assessments 120 days old or at discharge Necrotizing enterocolitis (NEC) 120 days old or at discharge Ventilator settings and FiO2 at 36 weeks 36 weeks post conceptual age Patent ductus arteriosus requiring drug or surgical treatment 36 weeks post conceptual age Bronchopulmonary dysplasia (BPD) 36 weeks post conceptual age Sepsis 120 days old or at discharge
Trial Locations
- Locations (17)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Stanford University
🇺🇸Palo Alto, California, United States
University of California at San Diego
🇺🇸San Diego, California, United States
Yale University
🇺🇸New Haven, Connecticut, United States
University of Miami
🇺🇸Miami, Florida, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
Wayne State University
🇺🇸Detroit, Michigan, United States
University of Rochester
🇺🇸Rochester, New York, United States
Wake Forest University
🇺🇸Charlotte, North Carolina, United States
Scroll for more (7 remaining)University of Alabama at Birmingham🇺🇸Birmingham, Alabama, United States