Project Details

Treatment of neonatal jaundice with filtered sunlight phototherapy: Safety and efficacy in African neonates in rural communities

Tina Slusher, MD

Summary

Background: Severe neonatal jaundice and its progression to kernicterus is a leading cause of preventable deaths and disabilities in low resource countries. High quality, blue light phototherapy is scarce in many of these countries due to lack of devices and erratic electric power. Objective: To compare the safety and efficacy of selectively filtered sunlight phototherapy (FS-PT) with that of conventional PT (CPT). Design/Methods: A prospective, randomized, controlled, non-inferiority trial to compare the safety and efficacy of FS-PT vs. CPT (primarily blue fluorescent lamp light) in the treatment of neonatal jaundice was performed in term and near-term infants ≤14-days old in a large, inner city Nigerian maternity hospital. A non-inferiority margin of 10% was chosen. Clinically significant jaundice was assessed by total serum bilirubin (TSB) levels using an Advanced® BR2 Analyzer. Sunlight was selectively filtered by using commercial window-tinting films that remove UV and reduce IR (heat) radiation, but transmit effective blue PT light. Irradiances (BiliBlanket ® II Meter) and hourly measurements of axillary body temperatures (ABT) were obtained in both study groups. TSB was determined at the start and end of each PT day. Treatment was deemed safe if the infant was able to stay under either PT without meeting safety withdrawal criteria (sustained temperature < 35.5 °C or > 38.0°C, dehydration or sunburn), and deemed efficacious if the rate of rise of TSB for infants receiving ≥ 5 h PT/day was <0.2 mg/dL/h for an infant ≤72 h of age or if TSB decreased for an infant >72 h of age. Results: 213 infants received 268 days of FS-PT compared to 220 infants who received 325 days of CPT. Irradiance (mean, range) was 40 (2-100) μW/cm2/nm for FS-PT vs. 17 (4-44) μW/cm2/nm for CPT. ABT was > 38.0°C in 85/1863 h of FS-PT vs. 15/2160 h of CPT.. ABT <35.5°C occurred in 8/1863 h of FS-PT vs. 2/2160 h of CPT. No infant in either group met safety withdrawal criteria. FS-PT was efficacious on 92% (231/250) vs. 90% (280/311) of the evaluable days for CPT. Mean rate of TSB change was -0.07 mg/dL/h in FS-PT vs. 0.00 mg/dL/h in CPT. Conclusions: FS-PT is no less efficacious than CPT in the treatment of neonatal jaundice. FS-PT offers a practical, affordable, safe, and often the only method to treat neonatal jaundice in low resource settings.

Keywords:

Human, Jaundice, Neuro-Cognitive Development, Randomized Clinical Trial, Treatment

Publications:

Slusher TM, Vreman HJ, Olusanya BO, et al. Safety and efficacy of filtered sunlight in treatment of jaundice in African neonates. Pediatrics. 2014;133(6):e1568-74.

Slusher, TM, Olusanya BO, Vreman HJ, Wong RJ, Brearley AM, Vaucher YE, Stevenson DK. Treatment of neonatal jaundice with filtered sunlight in Nigerian neonates: study protocol of a non-inferiority, randomized controlled trial. Trials 2013, 14:446

Slusher, TM, Olusanya, BO, Vreman, HJ, Brearly, AM, Vaucher, YE, Lund TC, Wong, RJ, Emokpae, AA Stevenson, DK. A Randomized Trial of Filtered Sunlight Phototherapy in Africa. New England Journal of Medicine. Impact Factor 55.873 in 2015 September 17;373(12):1115-1124.

Olusanya, Bolajoko O., Zainab O. Imam, Cecilia A. Mabogunje, Abieyuwa A. Emokpae, and Tina M. Slusher. "Maternal satisfaction with a novel filtered-sunlight phototherapy for newborn jaundice in Southwest Nigeria." BMC pediatrics 14, no. 1 (2014): 180.

Olusanya, Bolajoko O., Abieyuwa A. Emokpae, Tara G. Zamora, and Tina M. Slusher. "Addressing the burden of neonatal hyperbilirubinaemia in countries with significant glucose‐6‐phosphate dehydrogenase deficiency." Acta Paediatrica 103, no. 11 (2014): 1102-1109.