A Randomized Trial of Phototherapy with Filtered Sunlight in African Neonates

Tony Sampson, Mercer University College of Pharmacy

According to an article published in American Family Physician, hyperbilirubinemia can lead to deposition of unconjugated bilirubin in brain tissue and the effects are often devastating and irreversible.  It also states that after the first week of life, affected newborns begin to demonstrate effects of bilirubin toxicity. [1]

Per an article published in Paediatrics and Child Health, phototherapy remains the most convenient and safe means of lowering serum bilirubin and it reduces the need for potentially more hazardous alternative such as exchange transfusion. [2]

 Title: A Randomized Trial of Phototherapy with Filtered Sunlight in African Neonates [3]
Design Randomized, controlled, nonblinded, phase II, noninferiority trial; N= 447
Objective To prove noninferiority of filtered sunlight therapy compared to conventional phototherapy
Study Groups Filtered sunlight group n= 224, conventional phototherapy group n= 223
Methods Infants assigned to the group receiving filtered sunlight were placed under one of two previously tested film canopies depending on whether the sky was overcast, in which case the Air Blue 80 film was used, or sunny, in which case Gila Titanium film was used.  Infants were rotated between canopies as needed.  Both films filter out most ultraviolet A light (>99%), virtually all ultraviolet B and C light, and some infrared (heat) radiation while allowing passage of 84% (Air Blue 80) and 39% (Titanium) of therapeutic blue light (400 to 520 nm).  Infants assigned to receive conventional phototherapy were placed under phototherapy constructed according to published specifications with the use of locally available materials, with maintenance of irradiances of at least 8 to 10 μW per square centimeter per nanometer.  The indication for the use of conventional nighttime phototherapy in both groups was an afternoon total serum bilirubin that was at least the treatment level for age-in-hours recommended by the American Academy of Pediatrics.
Duration Between November 2012 and September 2013
Primary Outcome Measure A rate of increase in total serum bilirubin of less than 0.2 mg per deciliter per hour for infants up to 72 hours of age or a decrease in serum bilirubin for infants older than 72 hours of age who received at least five hours of phototherapy
Baseline Characteristics Characteristic Filtered-Sunlight Phototherapy (n= 224) Conventional Phototherapy (n= 223)
Male sex – no. (%) 122 (54) 120 (54)
Median Birth weight –kg 38 38
Median Hematocrit — % 53 55
Median initial total serum bilirubin on day one – mg/dl 5.9 6.2
ABO incompatibility  present – no./total no (%) 32/221 (61) 42/221 (19)
Rh incompatibility present – no./total no. (%) 8/222 (4) 5/221 (2)
Glucose-6-phosphate dehydrogenase deficient – no./total no. (%) 35/224 (16) 48/221 (22)
Results Variable Filtered-Sunlight Phototherapy Conventional Phototherapy
Median rate of change in total bilirubin – mg/dl/hr -0.07 0.00
Efficacy — % (95% CI) 93 (89 to 96) 90 (86 to 93)
Adverse Events Common Adverse Events: Hyperthermia >39.9 °C (<1%), Hyperthermia >38 °C (5%),  Hypothermia <35.0°C (<1%),
Serious Adverse Events: N/A
Percentage that Discontinued due to Adverse Events: N/A
Study Author Conclusions Filtered sunlight was noninferior to conventional phototherapy for the treatment of neonatal hyperbilirubinemia and did not result in any study withdrawals for reasons of safety.

Results of this study demonstrated that filtered sunlight was noninferior in efficacy to conventional sunlight which is the standard of treatment for neonatal hyperbilirubinemia.  A limitation of this study was that infants with severe hyperbilirubinemia (serum bilirubin ≥ 15 mg/dL) were not present and this population is most likely to be admitted for treatment.  In conclusion, this study showed that the use of filtered sunlight may have value as an alternative to conventional sunlight in the treatment of neonatal hyperbilirubinemia.

References

  1. Porter ML, Dennis BL. Hyperbilirubinemia in the term newborn. Am Fam Physician. 2002;65(4):599-606.
  2. Ives NK. Management of neonatal jaundice. Paediatrics and Child Health. 2015;25(6):276-281.
  3. Slusher TM, Olusanya BO, Vreman HJ, et al. A Randomized Trial of Phototherapy with Filtered Sunlight in African Neonates. N Engl J Med. 2015;373(12):1115-24.

 

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