Status:
COMPLETED
Trial of Aggressive Versus Conservative Phototherapy in Infants <1,000 Grams Birth Weight
Lead Sponsor:
NICHD Neonatal Research Network
Collaborating Sponsors:
National Center for Research Resources (NCRR)
Conditions:
Hyperbilirubinemia, Neonatal
Jaundice, Neonatal
Eligibility:
All Genders
12-36 years
Phase:
PHASE3
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 w...
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 unclea...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 501-1000 grams birth weight
- 12-36 hours postnatal age
- Exclusion criteria:
- Terminal condition (pH \<6.8 for \>2 hours OR persistent bradycardia, heart rate \<100 bpm, associated with hypoxia for \>2 hours\]
- Prior use of phototherapy
- Major congenital anomaly
- Hydrops fetalis or severe hemolytic disease diagnosed in-utero
- Overt congenital nonbacterial infection
- Parental refusal or inability to provide consent
- Attending physician refusal
- Parents who are considered unlikely to return for follow-up evaluation
Exclusion
Key Trial Info
Start Date :
September 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
1974 Patients enrolled
Trial Details
Trial ID
NCT00114543
Start Date
September 1 2002
End Date
November 1 2007
Last Update
March 22 2019
Active Locations (17)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
Stanford University
Palo Alto, California, United States, 94304
3
University of California at San Diego
San Diego, California, United States, 92103-8774
4
Yale University
New Haven, Connecticut, United States, 06504