Treatment of Neonatal Jaundice With Filtered Sunlight Phototherapy: Safety and Efficacy in African Neonates
Treatment of Neonatal Jaundice With Filtered Sunlight Phototherapy: Safety and Efficacy in African Neonates
The primary objective of this study is to determine the safety and efficacy of filtered
 sunlight phototherapy. Sunlight will be filtered by flexible (window-tinting) film. The
 subject population will be neonates born at Island Maternity Hospital, Lagos, Nigeria. The
 rationale for conducting the study is that in Nigeria, and other countries that may not have
 effective commercial light devices or have reliable access to electric power to operate them,
 filtered sunlight phototherapy might offer a safe and effective treatment for neonatal
 jaundice. Phase I of the study focused on the safety and efficacy of filtered sunlight
 phototherapy. Phase II of the study was a randomized controlled non-inferiority clinical
 trial comparing the efficacy of filtered sunlight phototherapy with conventional
 phototherapy.
Numerous studies from resource-limited countries suggest that severe neonatal jaundice (NNJ)
 represents the largest unrecognized cause of neonatal morbidity and mortality in the world.
 Several studies from Africa rank jaundice as a leading cause of death in newborn nurseries.
 In Nigeria, Owa and Osinaike reported that jaundice (14%) was the second leading cause of
 death, while Ugwu et al, found that mortality from severe jaundice was comparable to birth
 asphyxia but greater than sepsis in neonates >24 hrs old to 7 days old. In Kenya, English et
 al reported NNJ as the third leading cause of both newborn admissions and deaths. Studies
 from Nigeria, Zimbabwe, Turkey, North Vietnam, Oman, and India listed acute bilirubin
 encephalopathy (ABE) and/or severe NNJ as a significant cause of morbidity, many of whom
 required exchange blood transfusion (EBT) in their nurseries. Unfortunately, phototherapy, as
 important as it is, may not be available to many infants with NNJ in these countries because
 of the lack of devices and/or of unreliable electrical power supply. Commercial phototherapy
 (PT) devices are expensive, often break down due to surges in electrical power, and are
 difficult to maintain due to unavailability of spare parts. Even where PT devices are
 available, most hospitals in these countries lack the resources to replace the fluorescent
 light bulbs at the recommended 2000-3000 hrs of use and simply leave ineffective tubes in
 place until they burn out. Moreover, very few hospitals have appropriate irradiance meters
 for monitoring the intensity of the blue light emitted by the lamps. In a recent study in
 Nigeria by Owa et al, none of the tested PT devices provided the level of irradiance required
 for intensive PT.

 Often, the only treatment a healthcare provider can suggest to the parents/guardians of
 jaundiced infants is to place their babies in sunlight. However, this practice is unsuitable
 due to several safety concerns. For instance, exposure to ultraviolet (UV) light may cause
 sunburn, while infrared (IR) light may cause the body to overheat. Moreover, the infant may
 lose body heat from the uncovered skin during treatment, with potential for dehydration. A
 safer, yet practical and economical, solution is needed, providing the basis for our proposal
 of filtered sunlight PT.

 The primary aims of this study were safety, efficacy and non-inferiority of filtered sunlight
 phototherapy compared to conventional phototherapy. Phase I of the study focused on the
 safety and efficacy of filtered sunlight phototherapy. Phase II focused on non-inferiority of
 efficacy as compared to conventional phototherapy while continuing to evaluate safety.
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. At time of enrollment, infant has an elevated TcB defined as 3 mg/dL below 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 participation in the study if any of the following
 conditions exist at the time of enrollment:

 1. Infants with a condition requiring referral for treatment not available at the
 hospital study site and/or conventional phototherapy unit.

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

 3. Infants requiring oxygen therapy

 4. Infants clinically dehydrated or sunburned

 5. Infants with a temperature < 35.5 or > 38 degrees Centigrade

 6. Infants with ABE on clinical exam

 7. Infants meeting the criteria for EBT