N/A
N=447
Treatment of Neonatal Jaundice With Filtered Sunlight Phototherapy: Safety and Efficacy in African Neonates
Jaundice, Neonatal
Bottom Line
View on ClinicalTrials.gov: NCT01434810 ↗Enrolled (actual)
447
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcome: Primary: Safety of Phototherapy — 268; 325 treatment days
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Filtered-sunlight phototherapy (Device); Conventional phototherapy (Device)
- Age
- Pediatric
- Sex
- All
- Sponsor
- University of Minnesota
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety of Phototherapy |
268; 325 | — |
| PRIMARY Efficacy of Phototherapy |
232; 280 | — |
| SECONDARY Number of Participants Requiring Exchange Blood Transfusion |
0; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
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 38 degrees Centigrade
- Infants with ABE on clinical exam
- Infants meeting the criteria for EBT
Data sourced from ClinicalTrials.gov (NCT01434810). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.