Treatment of Neonatal Jaundice With Filtered Sunlight Phototherapy: Safety and Efficacy in African Neonates
|ClinicalTrials.gov Identifier: NCT01434810|
Recruitment Status : Completed
First Posted : September 15, 2011
Last Update Posted : June 3, 2015
|Condition or disease||Intervention/treatment||Phase|
|Jaundice, Neonatal||Procedure: Window tinting film for filtered sunlight phototherapy Device: Conventional phototherapy||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1273 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment of Neonatal Jaundice With Filtered Sunlight Phototherapy: Safety and Efficacy in African Neonates|
|Study Start Date :||November 2011|
|Primary Completion Date :||September 2013|
|Study Completion Date :||September 2013|
Active Comparator: Window tinting film for filtered sunlight phototherapy
Window tinting film
Procedure: Window tinting film for filtered sunlight phototherapy
Six hours per day of filtered sunlight phototherapy for 1 to 10 days.
Other Name: Window tinting films by Solutia, Inc., and V-KOOL, Inc.
Active Comparator: Conventional phototherapy
Infants will be randomized to conventional phototherapy (new arm)
Device: Conventional phototherapy
Conventional phototherapy unit will be used for infants randomized to this arm for 1 to 10 days.
- 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 four days, and a maximum of ten days.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01434810
|Island Maternity Hospital|
|Principal Investigator:||Tina M Slusher, MD||University of Minnesota - Clinical and Translational Science Institute|