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

 -  Subjects will be eligible to participate in the study if all of the following
 conditions exist:

 1. At time of birth, infant is > 35 weeks gestation (or ≥ 2.2 kg if gestational age
 is not available.

 2. Infant is < 14 days old at the time of enrollment.

 3. Infant has an elevated TB defined as at the level recommended for high-risk
 infants per AAP guidelines or higher.

 4. Parent or guardian has given consent for the infant to participate.

 Exclusion Criteria:

 -  Subjects will be excluded from enrollment in the study if any of the following
 conditions exist:

 1. Infants with a condition requiring referral for treatment not available at the
 hospital study site.

 2. Infants with a life-expectancy of < 24 hours at screening enrollment.

 3. Infants requiring oxygen therapy unless that can be provided while under PT.

 4. Infants clinically dehydrated or sunburned at the time of screening enrollment.

 5. Infants with a temperature < 36.0 or > 37.5 degrees Centigrade that does not
 return to normothermia within 1 hour.