Status:
COMPLETED
Treatment of Neonatal Jaundice With Filtered Sunlight Phototherapy: Safety and Efficacy in African Neonates
Lead Sponsor:
University of Minnesota
Collaborating Sponsors:
Thrasher Research Fund
Conditions:
Jaundice, Neonatal
Eligibility:
All Genders
Up to 14 years
Phase:
NA
Brief Summary
The primary objective of this study is to determine the safety and efficacy of filtered sunlight phototherapy. Sunlight will be filtered by flexible (window-tinting) film. The subject population will ...
Detailed Description
Numerous studies from resource-limited countries suggest that severe neonatal jaundice (NNJ) represents the largest unrecognized cause of neonatal morbidity and mortality in the world. Several studies...
Eligibility Criteria
Inclusion
- Subjects will be eligible to participate in the study if all of the following conditions exist:
- At time of birth, infant is \> 35 weeks gestation (or \> 2.2 kg if gestational age is not available
- Infant is \< 14 days old at the time of enrollment
- At time of enrollment, infant has an elevated TcB defined as 3 mg/dL below the level recommended for high-risk infants per AAP guidelines or higher
- Parent or guardian has given consent for the infant to participate
Exclusion
- Subjects will be excluded from participation in the study if any of the following conditions exist at the time of enrollment:
- Infants with a condition requiring referral for treatment not available at the hospital study site and/or conventional phototherapy unit.
- Infants with a life-expectancy of \< 24 hours
- Infants requiring oxygen therapy
- Infants clinically dehydrated or sunburned
- Infants with a temperature \< 35.5 or \> 38 degrees Centigrade
- Infants with ABE on clinical exam
- Infants meeting the criteria for EBT
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
447 Patients enrolled
Trial Details
Trial ID
NCT01434810
Start Date
November 1 2011
End Date
September 1 2013
Last Update
February 5 2019
Active Locations (1)
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1
Island Maternity Hospital
Lagos, Nigeria