Filtered Sunlight for Treatment of Neonatal Hyperbilirubinemia.
نویسندگان
چکیده
In this randomized, controlled non-inferiority trial, filtered sunlight was compared with conventional phototherapy for the treatment of hyperbilirubinemia in term and latepreterm neonates. The primary end point was efficacy, which was defined as a rate of increase in total serum bilirubin of less than 0.2 mg/dL/h 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. Authors pre-specified a non-inferiority margin of 10% for the difference in efficacy rates between groups. The need for an exchange transfusion was a secondary end point. Safety, which was defined as the absence of the need to withdraw therapy because of hyperthermia, hypothermia, dehydration, or sunburn, was also assessed. Of the total 447 infants, 224 were randomly assigned 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 μW/cm2/nm; P<0.001). No infant met the criteria for withdrawal from the study for reasons of safety or required an exchange transfusion. Authors concluded that filtered sunlight was non-inferior to conventional phototherapy for the treatment of neonatal hyperbilirubinemia.
منابع مشابه
Filtered Sunlight for Treatment of Neonatal Hyperbilirubinemia, A Rejoinder.
We note the interest generated in this journal [1], on our paper [2], and wish to provide the following clarifications for the benefit of the readership. Dr. Mathew’s opinion was that our study had a high risk of bias principally because: (i) specific method used for the sequence generation was unclear; (ii) the primary outcome (rate of bilirubin decline) assessors were not blinded; and (iii) ‘...
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ورودعنوان ژورنال:
- Indian pediatrics
دوره 52 12 شماره
صفحات -
تاریخ انتشار 2015