Treatment of neonatal jaundice with filtered sunlight in Nigerian neonates: study protocol of a non-inferiority, randomized controlled trial
1 Center for Global Health, Department of Pediatrics, University of Minnesota, Minneapolis, MN, USA
2 Department of Pediatrics, Hennepin County Medical Center, Minneapolis, MN, USA
3 Center for Healthy Start Initiative, Dolphin Estate, Ikoyi, Lagos, Nigeria
4 Neonatal and Developmental Medicine Laboratory, Division of Neonatology, Department of Pediatrics, Stanford University Medical Center, Stanford, CA, USA
5 Biostatistical Design and Analysis Center, Clinical and Translational Science Institute, University of Minnesota Academic Health Center, Minneapolis, MN, USA
6 Division of Neonatal/Perinatal Medicine, School of Medicine, University of California at San Diego, San Diego, CA, USA
Trials 2013, 14:446 doi:10.1186/1745-6215-14-446Published: 28 December 2013
Severe neonatal jaundice and its progression to kernicterus is a leading cause of death and disability among newborns in poorly-resourced countries, particularly in sub-Saharan Africa. The standard treatment for jaundice using conventional phototherapy (CPT) with electric artificial blue light sources is often hampered by the lack of (functional) CPT devices due either to financial constraints or erratic electrical power. In an attempt to make phototherapy (PT) more readily available for the treatment of pathologic jaundice in underserved tropical regions, we set out to test the hypothesis that filtered sunlight phototherapy (FS-PT), in which potentially harmful ultraviolet and infrared rays are appropriately screened, will be as efficacious as CPT.
This prospective, non-blinded randomized controlled non-inferiority trial seeks to enroll infants with elevated total serum/plasma bilirubin (TSB, defined as 3 mg/dl below the level recommended by the American Academy of Pediatrics for high-risk infants requiring PT) who will be randomly and equally assigned to receive FS-PT or CPT for a total of 616 days at an inner-city maternity hospital in Lagos, Nigeria. Two FS-PT canopies with pre-tested films will be used. One canopy with a film that transmits roughly 33% blue light (wavelength range: 400 to 520 nm) will be used during sunny periods of a day. Another canopy with a film that transmits about 79% blue light will be used during overcast periods of the day. The infants will be moved from one canopy to the other as needed during the day with the goal of keeping the blue light irradiance level above 8 μW/cm2/nm.
Primary outcome: FS-PT will be as efficacious as CPT in reducing the rate of rise in bilirubin levels. Secondary outcome: The number of infants requiring exchange transfusion under FS-PT will not be more than those under CPT.
This novel study offers the prospect of an effective treatment for infants at risk of severe neonatal jaundice and avoidable exchange transfusion in poorly-resourced settings without access to (reliable) CPT in the tropics.
ClinicalTrials.gov Identifier: NCT01434810