This is a multi-center trial to compare aggressive or conservative phototherapy in Extremely Low Birth Weight (ELBW) infants. The primary hypothesis is that there will be no difference in death or neurodevelopmental impairment at 18-22 months corrected age in infants treated by either aggressive or conservative phototherapy. Plans call for the enrollment of approximately 2,000 ELBW infants.

Condition	Intervention	Phase
Hyperbilirubinemia Death	Procedure: Different styles of using phototherapy	Phase III

Further Study Details: 

Expected Total Enrollment:  1976

Phototherapy has been administered to 94% of ELBW infants who survive more than 12 hours in Network centers. Yet, the serum bilirubin level that is harmful to ELBW infants is unclear and there are no data from large or recent clinical trials to define the risk, 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 between 1974 and 1976 and included only 77 ELBW infants. Data from this study and others suggest that phototherapy could have important hazards as well as important benefits in ELBW infants. The proposed study is designed to be a multi-center trial to compare aggressive or conservative phototherapy in 1,976 ELBW infants. The primary hypothesis is that there will be no difference in death or neurodevelopmental impairment at 18-22 months in infants treated by aggressive or conservative phototherapy regimens.

Infants randomized to the Aggressive phototherapy regimen will be started on phototherapy at enrollment (12-36 hours after birth, preferably before 24 hours). In the Aggressive group the infants with birth weight 501-750 grams or 751-1000 g will have a threshold level for restarting and stopping phototherapy of 5 mg/dl for day of life (DOL) #1-14 or 5 mg/dl for DOL #1-7 and 7mg/dl for DOL #8-14, respectively. Infants randomized to the Conservative phototherapy regimen will be started on phototherapy when the total serum bilirubin reaches a threshold of 8.0 mg/dl for infants with birth weights of 501-750 g and 10.0 mg/dl for infants with birth weights of 751-1000 g. These threshold levels will remain the restart/stop levels for DOL #1-14. The phototherapy regimens are designed to fall within the range of clinical practice and to assure a sizable difference between groups in serum bilirubin levels and duration of phototherapy. The primary outcome will be death or neurodevelopmental impairment at 18-22 months corrected age determined at an outpatient clinic visit. Secondary outcomes will include death, abnormal neurodevelopmental outcome, deafness, cerebral palsy, patent ductus arteriosus, and retinopathy of prematurity (outcomes related to bilirubin levels or phototherapy in prior studies). The study is designed to identify a 7% or greater risk difference between the treatment group with the higher rate of death or impairment and the treatment group with the lower rate (power = 0.80; alpha error=0.05). Using conservative estimates, 1,976 total infants would need to be enrolled to meet this requirement.

Ages Eligible for Study:  up to  36 Hours,  Genders Eligible for Study:  Both

Criteria

• ELBW infants

Texas
      University of Texas Medical School at Houston, Houston,  Texas,  77030,  United States

Study chairs or principal investigators

Brenda Morris, MD,  Principal Investigator,  University of Texas Medical School at Houston   

Study ID Numbers:  NICHD-1013; 2U10HD021373
Record last reviewed:  June 2005
Last Updated:  June 30, 2005
Record first received:  June 15, 2005
ClinicalTrials.gov Identifier:  NCT00114543
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-07-05