CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 174 enrolled
Drug / intervention
Filtered-sunlight phototherapy +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02612727
NCT02612727N/ACompleted

Filtered Sunlight Phototherapy to Treat Significant Jaundice: Safety and Efficacy in Neonates

University of Minnesota·interventional·Posted Nov 24, 2015·Updated Jul 9, 2019

In Brief

A clinical study evaluating Filtered-sunlight phototherapy and Intensive phototherapy for Jaundice, Neonatal. Completed, enrolled 174 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesNigeria

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 24, 2015
Enrollment StartNov 1, 2012
Primary CompletionSep 1, 2013
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 10.6 years ago

Interventions

Filtered-sunlight phototherapydevice

Infants will receive \>= four hours per day of filtered-sunlight phototherapy for 1 to 10 days. The filtering will be done using Air Blue 80 window tinting film.

Intensive phototherapydevice

Infants will receive \>= four hours per day of intensive phototherapy for 1 to 10 days.