A randomized trial of phototherapy with filtered sunlight in african neonates

Tina M. Slusher, Bolajoko O. Olusanya, Hendrik J. Vreman, Ann M. Brearley, Yvonne E. Vaucher, Troy C. Lund, Ronald J. Wong, Abieyuwa A. Emokpae, David K. Stevenson

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Abstract

BACKGROUND Sequelae of severe neonatal hyperbilirubinemia constitute a substantial disease burden in areas where effective conventional phototherapy is unavailable. We previously found that the use of filtered sunlight for the purpose of phototherapy is a safe and efficacious method for reducing total bilirubin. However, its relative safety and efficacy as compared with conventional phototherapy are unknown. METHODS We conducted a randomized, controlled noninferiority trial in which filtered sunlight was compared with conventional phototherapy for the treatment of hyperbilirubinemia in term and late-preterm neonates in a large, urban Nigerian maternity hospital. The primary end point was efficacy, which was defined as 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 total serum bilirubin for infants older than 72 hours of age who received at least 5 hours of phototherapy; we prespecified a noninferiority margin of 10% for the difference in efficacy rates between groups. The need for an exchange transfusion was a secondary end point. We also assessed safety, which was defined as the absence of the need to withdraw therapy because of hyperthermia, hypothermia, dehydration, or sunburn. RESULTS We enrolled 447 infants and randomly assigned 224 to filtered sunlight and 223 to conventional phototherapy. Filtered sunlight was efficacious on 93% of treatment days that could be evaluated, as compared with 90% for conventional phototherapy, and had a higher mean level of irradiance (40 vs. 17 ìW per square centimeter per nanometer, P<0.001). Temperatures higher than 38.0°C occurred in 5% of the infants receiving filtered sunlight and in 1% of those receiving conventional phototherapy (P<0.001), but no infant met the criteria for withdrawal from the study for reasons of safety or required an exchange transfusion. 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. (Funded by the Thrasher Research Fund, Salt Lake City, and the National Center for Advancing Translational Sciences of the National Institutes of Health; Clinical Trials.gov number, NCT01434810.).

Original languageEnglish (US)
Pages (from-to)1115-1124
Number of pages10
JournalNew England Journal of Medicine
Volume373
Issue number12
DOIs
StatePublished - Sep 17 2015

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Phototherapy
Sunlight
Newborn Infant
Bilirubin
Neonatal Hyperbilirubinemia
Safety
Sunburn
Maternity Hospitals
Hyperbilirubinemia
National Institutes of Health (U.S.)
Therapeutics
Hypothermia
Serum
Dehydration
Fever
Randomized Controlled Trials
Clinical Trials
Temperature

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A randomized trial of phototherapy with filtered sunlight in african neonates. / Slusher, Tina M.; Olusanya, Bolajoko O.; Vreman, Hendrik J.; Brearley, Ann M.; Vaucher, Yvonne E.; Lund, Troy C.; Wong, Ronald J.; Emokpae, Abieyuwa A.; Stevenson, David K.

In: New England Journal of Medicine, Vol. 373, No. 12, 17.09.2015, p. 1115-1124.

Research output: Contribution to journalArticle

Slusher, TM, Olusanya, BO, Vreman, HJ, Brearley, AM, Vaucher, YE, Lund, TC, Wong, RJ, Emokpae, AA & Stevenson, DK 2015, 'A randomized trial of phototherapy with filtered sunlight in african neonates', New England Journal of Medicine, vol. 373, no. 12, pp. 1115-1124. https://doi.org/10.1056/NEJMoa1501074
Slusher, Tina M. ; Olusanya, Bolajoko O. ; Vreman, Hendrik J. ; Brearley, Ann M. ; Vaucher, Yvonne E. ; Lund, Troy C. ; Wong, Ronald J. ; Emokpae, Abieyuwa A. ; Stevenson, David K. / A randomized trial of phototherapy with filtered sunlight in african neonates. In: New England Journal of Medicine. 2015 ; Vol. 373, No. 12. pp. 1115-1124.
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abstract = "BACKGROUND Sequelae of severe neonatal hyperbilirubinemia constitute a substantial disease burden in areas where effective conventional phototherapy is unavailable. We previously found that the use of filtered sunlight for the purpose of phototherapy is a safe and efficacious method for reducing total bilirubin. However, its relative safety and efficacy as compared with conventional phototherapy are unknown. METHODS We conducted a randomized, controlled noninferiority trial in which filtered sunlight was compared with conventional phototherapy for the treatment of hyperbilirubinemia in term and late-preterm neonates in a large, urban Nigerian maternity hospital. The primary end point was efficacy, which was defined as 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 total serum bilirubin for infants older than 72 hours of age who received at least 5 hours of phototherapy; we prespecified a noninferiority margin of 10{\%} for the difference in efficacy rates between groups. The need for an exchange transfusion was a secondary end point. We also assessed safety, which was defined as the absence of the need to withdraw therapy because of hyperthermia, hypothermia, dehydration, or sunburn. RESULTS We enrolled 447 infants and randomly assigned 224 to filtered sunlight and 223 to conventional phototherapy. Filtered sunlight was efficacious on 93{\%} of treatment days that could be evaluated, as compared with 90{\%} for conventional phototherapy, and had a higher mean level of irradiance (40 vs. 17 {\`i}W per square centimeter per nanometer, P<0.001). Temperatures higher than 38.0°C occurred in 5{\%} of the infants receiving filtered sunlight and in 1{\%} of those receiving conventional phototherapy (P<0.001), but no infant met the criteria for withdrawal from the study for reasons of safety or required an exchange transfusion. 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. (Funded by the Thrasher Research Fund, Salt Lake City, and the National Center for Advancing Translational Sciences of the National Institutes of Health; Clinical Trials.gov number, NCT01434810.).",
author = "Slusher, {Tina M.} and Olusanya, {Bolajoko O.} and Vreman, {Hendrik J.} and Brearley, {Ann M.} and Vaucher, {Yvonne E.} and Lund, {Troy C.} and Wong, {Ronald J.} and Emokpae, {Abieyuwa A.} and Stevenson, {David K.}",
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AU - Slusher, Tina M.

AU - Olusanya, Bolajoko O.

AU - Vreman, Hendrik J.

AU - Brearley, Ann M.

AU - Vaucher, Yvonne E.

AU - Lund, Troy C.

AU - Wong, Ronald J.

AU - Emokpae, Abieyuwa A.

AU - Stevenson, David K.

PY - 2015/9/17

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N2 - BACKGROUND Sequelae of severe neonatal hyperbilirubinemia constitute a substantial disease burden in areas where effective conventional phototherapy is unavailable. We previously found that the use of filtered sunlight for the purpose of phototherapy is a safe and efficacious method for reducing total bilirubin. However, its relative safety and efficacy as compared with conventional phototherapy are unknown. METHODS We conducted a randomized, controlled noninferiority trial in which filtered sunlight was compared with conventional phototherapy for the treatment of hyperbilirubinemia in term and late-preterm neonates in a large, urban Nigerian maternity hospital. The primary end point was efficacy, which was defined as 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 total serum bilirubin for infants older than 72 hours of age who received at least 5 hours of phototherapy; we prespecified a noninferiority margin of 10% for the difference in efficacy rates between groups. The need for an exchange transfusion was a secondary end point. We also assessed safety, which was defined as the absence of the need to withdraw therapy because of hyperthermia, hypothermia, dehydration, or sunburn. RESULTS We enrolled 447 infants and randomly assigned 224 to filtered sunlight and 223 to conventional phototherapy. Filtered sunlight was efficacious on 93% of treatment days that could be evaluated, as compared with 90% for conventional phototherapy, and had a higher mean level of irradiance (40 vs. 17 ìW per square centimeter per nanometer, P<0.001). Temperatures higher than 38.0°C occurred in 5% of the infants receiving filtered sunlight and in 1% of those receiving conventional phototherapy (P<0.001), but no infant met the criteria for withdrawal from the study for reasons of safety or required an exchange transfusion. 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. (Funded by the Thrasher Research Fund, Salt Lake City, and the National Center for Advancing Translational Sciences of the National Institutes of Health; Clinical Trials.gov number, NCT01434810.).

AB - BACKGROUND Sequelae of severe neonatal hyperbilirubinemia constitute a substantial disease burden in areas where effective conventional phototherapy is unavailable. We previously found that the use of filtered sunlight for the purpose of phototherapy is a safe and efficacious method for reducing total bilirubin. However, its relative safety and efficacy as compared with conventional phototherapy are unknown. METHODS We conducted a randomized, controlled noninferiority trial in which filtered sunlight was compared with conventional phototherapy for the treatment of hyperbilirubinemia in term and late-preterm neonates in a large, urban Nigerian maternity hospital. The primary end point was efficacy, which was defined as 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 total serum bilirubin for infants older than 72 hours of age who received at least 5 hours of phototherapy; we prespecified a noninferiority margin of 10% for the difference in efficacy rates between groups. The need for an exchange transfusion was a secondary end point. We also assessed safety, which was defined as the absence of the need to withdraw therapy because of hyperthermia, hypothermia, dehydration, or sunburn. RESULTS We enrolled 447 infants and randomly assigned 224 to filtered sunlight and 223 to conventional phototherapy. Filtered sunlight was efficacious on 93% of treatment days that could be evaluated, as compared with 90% for conventional phototherapy, and had a higher mean level of irradiance (40 vs. 17 ìW per square centimeter per nanometer, P<0.001). Temperatures higher than 38.0°C occurred in 5% of the infants receiving filtered sunlight and in 1% of those receiving conventional phototherapy (P<0.001), but no infant met the criteria for withdrawal from the study for reasons of safety or required an exchange transfusion. 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. (Funded by the Thrasher Research Fund, Salt Lake City, and the National Center for Advancing Translational Sciences of the National Institutes of Health; Clinical Trials.gov number, NCT01434810.).

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