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Correspondence

Indian Pediatr 2016;53: 440-441

Filtered Sunlight for Treatment of Neonatal Hyperbilirubinemia: A Rejoinder: Author’s Reply

 

Joseph L Mathew

Advanced Pediatrics Centre, PGIMER, Chandigarh, India.
Email: [email protected] 

  


1. The trial protocol (Contents page), in the supplementary data [1] states that the Randomization procedure is presented in Section 5.2 on page 23; however Section 5.2 described Laboratory procedures (and not Randomization). The trial protocol published in the journal ‘Trials’ [2] also does not describe the random sequence generation process; it only states: "A block randomization procedure with variable block sizes will be used to maximize unpredictability". Thus, as pointed out in the Commentary [3], the procedure used to generate the randomization sequence is ‘unclear’.

2. The authors’ assertion: "computer-generated block randomization done independently by the USA based study statistician" is not found either in the Supplementary data [1] or the published trial protocol [2]. The published paper [1] states that the external statistician performed allocation concealment (and not random sequence generation). The Commentary [3] already reported that allocation concealment was adequate.

3. The supplementary data [1] (Contents page) states that Blinding is described in Section 5.3 on page 23; however this section is missing in the text. The published protocol [2] states "TSB will be estimated using standard methods" without commenting on blinding. Thus it does not appear that blinding of the outcome assessor was done, hence it was described as ‘Inadequate’ [3]. Although many randomized trials cannot (and need not) include blinding of outcome assessors, the importance in this trial has already been highlighted previously [3].

4. The Supplementary data [1] and published protocol [2] have two different sample size calculations. The former describes a sample size of 124 infants (days of phototherapy not mentioned), whereas the latter describes the sample size as 560 treatment days. Neither affects the assessment that there is lack of clarity for information provided on the number of infants in the safety analysis [3]. It is important to note that this criterion has to be evaluated in trials for each outcome.

5. What can we learn (and apply) from this trial? Filtered sunlight could be efficacious for mild(er) neonatal jaundice (recall that the threshold was 3 mg/dL lower than standard practice) and can be used if (i) intensive monitoring is performed (as in the trial) and (ii) adequate backup phototherapy units are available (as about 1 in 7 babies would require phototherapy). Unfortunately, the trial does not explore whether we can predict which babies will require phototherapy, making it necessary to have back-up arrangements.

References

1. Slusher TM, Olusanya BO, Vreman HJ, Brearley AM, Vaucher YE, Lund TC, et al. A randomized trial of phototherapy with filtered sunlight in African neonates. N Engl J Med. 2015;373:1115-24.

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

3. Mathew JL, Kumar A, Khan AM. Filtered sunlight for treatment of neonatal hyperbilirubinemia. Indian Pediatrics. 2015;52:1075-9.   

 

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