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Indian Pediatr 2016;53: 440 |
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Filtered Sunlight for Treatment of Neonatal
Hyperbilirubinemia: A Rejoinder
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*Bolajoko O Olusanya and
#Tina M Slusher
Centre for Healthy Start Initiative, 286A Corporation
Drive, Dolphin Estate, Ikoyi, Lagos, Nigeria;
and #Department of Pediatrics, University of Minnesota and Hennepin
County Medical Center,
Minneapolis, MN, USA
Email:
[email protected]
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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)
‘treatment days’, rather than ‘number of infants enrolled’ was chosen as
unit of measurement.
First, Dr Matthew apparently overlooked details
provided in our study protocol on the computer-generated block
randomization done independently by the USA-based study statistician
(provided as supplementary data to the main article [2]. The
randomization method was indeed ‘adequate’ [3]. Second, as in most
clinical settings, bilirubin levels were objectively determined by the
laboratory technician using duly calibrated bilirubinometer on blood
samples from the infants at stated intervals to monitor need for
continuation or withdrawal of treatment by filtered sunlight or
conventional phototherapy. As reported [2,4], the laboratory technician
responsible for measuring serum bilirubin levels was unaware of the
treatment allocation sequence prior to bilirubin determination for
eligible infants. As our primary outcome was objectively measured and
the risk of bias minimal, blinding of the participating parents, or the
hospital personnel was considered unnecessary [2,3,5]. Third, the stated
aim was to compare the rate of bilirubin decline in babies able to
tolerate filtered sunlight or conventional phototherapy for at least 5
hours. As interruptions in the management of temperatures outside the
acceptable range were not predetermined, treatment days were variable.
Hence, the need to appropriately define the unit of measurement as a
‘treatment day’ rather than ‘number of infants’ randomized. This formed
the basis of the required sample size. There was indeed no statistical
or ethical justification for continuing with enrolment once the required
treatment days had been achieved.
Finally, available evidence suggests that mothers and
care-givers, with or without active support from health care providers
will continue to expose their jaundiced infants to sunlight [6]. The
duty of care, especially in populations with excessive rates of
avoidable bilirubin encephalopathy [7], should compel care-providers to
explore safe and efficacious means of applying filtered sunlight where
conventional phototherapy cannot be readily assured. This is the
overarching message and merit of our novel study. Appropriate adaptions
should follow in earnest, to optimize the benefit of this low-cost, low
maintenance and readily available intervention, wherever possible.
References
1. Mathew JL, Kumar A, Khan AM. Filtered sunlight for
treatment of neonatal hyperbilirubinemia. Indian Pediatr.
2015;52:1075-9.
2. 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.
3. Higgins JP, Altman DG, Gøtzsche PC, Jüni P, Moher
D, Oxman AD, et al. Cochrane Bias Methods Group; Cochrane
Statistical Methods Group. The Cochrane Collaboration’s tool for
assessing risk of bias in randomised trials. BMJ. 2011;343:d5928.
4. 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.
5. Boutron I, Tubach F, Giraudeau B, Ravaud P.
Blinding was judged more difficult to achieve and maintain in
non-pharmacologic than pharmacologic trials. J Clin Epidemiol.
2004;57:543-50.
6. Olusanya BO, Ogunlesi TA, Kumar P, Boo NY,
Iskander IF, de Almeida MF, et al. Management of late-preterm and
term infants with hyperbilirubinaemia in resource-constrained settings.
BMC Pediatr. 2015;15:39.
7. Olusanya BO, Ogunlesi TA, Slusher TM. Why is
kernicterus still a major cause of death and disability in low-income
and middle-income countries? Arch Dis Child. 2014;99:1117-21.
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