NCT02612727

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 174 (actual)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 14 Days
• Healthy volunteers: Accepted

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.

Detailed description

Severe neonatal hyperbilirubinemia (NHB) and its progression to kernicterus is a leading cause of deaths and disabilities among newborns in the developing world, particularly in sub-Saharan Africa including Nigeria. Many infants live in villages/towns far from clinical facilities capable of providing conventional artificial blue light phototherapy (CPT) which is the standard treatment for NHB in the industrialized world. Hence, more babies succumb to this preventable tragedy principally on account of lack of electricity and/or available/affordable CPT. To make treatment of NHB more readily available, we designed and tested a novel, yet simple, practical alternative device to deliver blue light PT in underserved areas from filtered sunlight. The investigators pilot study demonstrated that appropriately filtered sunlight phototherapy (FS-PT) not only offers safe and affordable treatment for infants with mild-moderate NHB, but is also no less efficacious than CPT. Other studies have shown faster decline at higher bilirubin (TB) levels and with higher irradiances. The next logical step to move this urgently needed and exciting therapy forward is to test FS-PT in infants with significant/severe NHB as defined by the American Academy of Pediatrics (AAP) criteria for high-risk infants. In doing so, the investigators will potentially be preventing acute bilirubin encephalopathy (ABE) and kernicterus in many of these infants.

Conditions

• Jaundice, Neonatal

Interventions

Type	Name	Description
DEVICE	Filtered-sunlight phototherapy	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.
DEVICE	Intensive phototherapy	Infants will receive \>= four hours per day of intensive phototherapy for 1 to 10 days.

Timeline

• Start date: 2012-11-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2015-11-24
• Last updated: 2019-07-09
• Results posted: 2019-06-19

Locations

1 site across 1 country: Nigeria