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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:

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
Sponsor: University of Minnesota - Clinical and Translational Science Institute

Current Primary Outcome:

  • Phase I: Safety of Filtered Sunlight Phototherapy [ Time Frame: Four to ten days ]
    Safety is defined as the ability to tolerate at least 5 hours of sunlight phototherapy per day while maintaining normothermia (axillary temperature of 35.5-38.0 degrees Centigrade) without significant dehydration or sunburn. Infants will be monitored hourly for temperature, sunburn and dehydration during the duration of sunlight phototherapy exposure, for an expected average of four days and a maximum of ten days.
  • Phase I: Efficacy of Filtered Sunlight Phototherapy [ Time Frame: Four to ten days ]
    Efficacy is defined as a rate of rise in total bilirubin <0.2 mg/dL/h for infants ≤72h of age, or fall in total bilirubin for infants >72h of age receiving ≥5h of phototherapy. Serum bilirubin will be measured twice daily during filtered sunlight phototherapy exposure, for an expected average of four days, and a maximum of ten days.
  • Phase II: Non-inferiority in Efficacy of Sunlight Phototherapy Compared to Conventional Phototherapy [ Time Frame: Four to ten days ]
    For Phase II of this study, we wish to demonstrate that the efficacy of filtered sunlight phototherapy is not worse than conventional phototherapy. The primary outcome for Phase II of this study is non-inferiority of efficacy, with a margin of 10 %. Efficacy is defined as a rate of rise in total bilirubin <0.2 mg/dL/h for infants ≤72h of age, or fall in total bilirubin for infants >72h of age receiving ≥5h of phototherapy. Serum bilirubin will be measured twice daily during filtered sunlight or conventional phototherapy exposure, for an expected average of

    Original Primary Outcome:

    • 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). ]
      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). ]
      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.


    Current Secondary Outcome: Number of participants requiring intervention such as exchange blood transfusion [ Time Frame: Four to ten days ]

    Intervention, such as exchange blood transfusion, required to lower the bilirubin level. Serum bilirubin will be measured twice daily during filtered sunlight or conventional phototherapy exposure, for an expected average of four days, and a maximum of ten days.


    Original Secondary Outcome: 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). ]

    Intervention, such as exchange blood transfusion, required to lower the bilirubin level.


    Information By: University of Minnesota - Clinical and Translational Science Institute

    Dates:
    Date Received: August 30, 2011
    Date Started: November 2011
    Date Completion:
    Last Updated: June 1, 2015
    Last Verified: June 2015