Treatment of Neonatal Jaundice With Filtered Sunlight Phototherapy: Safety and Efficacy in African Neonates

• Change in Serum Bilirubin [ Time Frame: Serum bilirubin will be measured daily during sunlight phototherapy exposure (for an expected average of four days, and a maximum of ten days). ] [ Designated as safety issue: Yes ]
  Diminished rate of total serum bilirubin for infants less than or equal to 72 hours old and a decline of total serum bilirubin in infants greater than 72 hour old.
  
  
• Incidence of Sunburn and Dehydration [ Time Frame: Infants will be monitored hourly for sunburn and dehydration during the duration of sunlight phototherapy exposure (for an expected average of four days and a maximum of ten days). ] [ Designated as safety issue: Yes ]
  Ability to tolerate at least 6 hours of sunlight phototherapy per day while maintaining normothermia (axillary temperature of 36.5-37.5 degrees Centigrade) without significant dehydration or sunburn.
  
  
• Non-inferiority of sunlight phototherapy [ Time Frame: Serum bilirubin will be measured twice daily in both infants receiving sunlight and conventional phototherapy ] [ Designated as safety issue: Yes ]
  We wish to demonstrate that the efficacy of sunlight PT is not worse than that of conventional PT (non-inferiority study)
  
  

• Number of participants requiring intervention such as exchange blood transfusion [ Time Frame: Data will be recorded daily during sunlight phototherapy exposure (for an expected average of four days and a maximum of ten days). ] [ Designated as safety issue: Yes ]
  Intervention, such as exchange blood transfusion, required to lower the bilirubin level.
  
  

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.