Trial of Aggressive Versus Conservative Phototherapy in Infants <1,000 Grams Birth Weight
(Phototherapy Trial)
Recruiting in Palo Alto (17 mi)
+16 other locations
Overseen byT. Michael O'Shea, MD MPH
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: NICHD Neonatal Research Network
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?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.
Eligibility Criteria
Inclusion Criteria
501-1000 grams birth weight
12-36 hours postnatal age
Participant Groups
4Treatment groups
Active Control
Group I: Conservative VLBWActive Control1 Intervention
In the Conservative group 2, infants with birth weights 751-1000g.
Group II: Conservative ELBWActive Control1 Intervention
In the Conservative group 1, infants with birth weights 501-750g.
Group III: Aggressive VLBWActive Control1 Intervention
In the Aggressive group 2, infants with birth weights 751-1000g.
Group IV: Aggressive ELBWActive Control1 Intervention
In Aggressive group 1, infants with birth weights 501-750g.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Indiana UniversityIndianapolis, IN
Yale UniversityNew Haven, CT
Emory UniversityAtlanta, GA
University of California at San DiegoSan Diego, CA
More Trial Locations
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Who Is Running the Clinical Trial?
NICHD Neonatal Research NetworkLead Sponsor
National Center for Research Resources (NCRR)Collaborator