Mode
Text Size
Log in / Sign up
N/A N=174 Randomized Treatment

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

Jaundice, Neonatal

Enrolled (actual)
174
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcome: Primary: Efficacy of Phototherapy — 116; 135 treatment days

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Filtered-sunlight phototherapy (Device); Intensive phototherapy (Device)
Age
Pediatric
Sex
All
Sponsor
University of Minnesota
Primary completion
Sep 2013

Outcome Measures

OutcomeResultp-value
PRIMARY
Efficacy of Phototherapy
116; 135
PRIMARY
Safety of Phototherapy
215; 219

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.

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.
View full record on ClinicalTrials.gov →

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.

Back to search