N/A
Completed N=174
Filtered Sunlight Phototherapy to Treat Significant Jaundice: Safety and Efficacy in Neonates
Jaundice, Neonatal
Source: ClinicalTrials.gov NCT02612727 ↗
Enrolled (actual)
174
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcomePrimary: Efficacy of Phototherapy — 116; 135 treatment days
Summary
At present, much of sub-Saharan Africa, including Nigeria and other resource-limited countries, are without ready access to CPT, due to factors including the lack of PT devices, which are expensive and require consistent electric power to operate. NHB is a significant cause of neonatal morbidity and mortality, but preventable when appropriate treatment is initiated. We have shown that FS-PT is safe and efficacious for the treatment of mild-moderate NHB. The major goal of this study is to demonstrate that FS-PT is efficacious for the treatment of significant/severe NHB, generally defined as TB of ≥12-14mg/dL (but more specially as defined as needing phototherapy per American Academy of Pediatric 2004 guidelines). This arm was done at 1 site in Nigeria (in Ogbomoso). The rationale for conducting the study is that in Nigeria, and other countries that cannot afford effective commercial light devices and/or have no reliable electric power to operate them, filtered sunlight phototherapy might offer a safe and effective treatment for neonatal jaundice.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy of Phototherapy |
116; 135 | — |
| PRIMARY Safety of Phototherapy |
215; 219 | — |
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 37.5 degrees Centigrade that does not return to normothermia within 1 hour.
Data sourced from ClinicalTrials.gov (NCT02612727). 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. Informational only — not medical advice.