Treatment of Neonatal Jaundice With Filtered Sunlight Phototherapy: Safety and Efficacy in Africa… (NCT01434810) | Clinical Trial Compass
CompletedNot Applicable
Treatment of Neonatal Jaundice With Filtered Sunlight Phototherapy: Safety and Efficacy in African Neonates
Nigeria447 participantsStarted 2011-11
Plain-language 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 be neonates born at Island Maternity Hospital, Lagos, Nigeria. The rationale for conducting the study is that in Nigeria, and other countries that may not have effective commercial light devices or have reliable access to electric power to operate them, filtered sunlight phototherapy might offer a safe and effective treatment for neonatal jaundice. Phase I of the study focused on the safety and efficacy of filtered sunlight phototherapy. Phase II of the study was a randomized controlled non-inferiority clinical trial comparing the efficacy of filtered sunlight phototherapy with conventional phototherapy.
Who can participate
Age range14 Days
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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