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Indian Pediatr 2018;55:
617 |
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Pain Control Interventions in Preterm Neonates: Few concerns:
Authors Reply
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Vivek Vishwanath Shukla
The Hospital for Sick Children, 555
University Avenue, Toronto, ON M5G 1X8.
Email:
[email protected]
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1. We agree completely with the finer nuances of
randomization, intention-to- treat (ITT) and per-protocol analysis.
However, the real question beyond these semantics is whether the
study findings are valid and generalizable. We could have omitted
the record and carried the analysis with 49 participants in one
group and 50 in all other groups. We believe that shifting one
participant from Music therapy group to control group will not
hamper the validity of the results; albeit technically, it is a
breach of randomization. At the same time, it is incumbent to
mention this deviation from the plan following principles of honesty
and integrity in research.
2. The correct gestational age for the study
participants is 26-36 weeks. Although we planned to include
participants starting from 26 weeks, they were not stable and hence
not eligible to undergo study interventions. Thus, we ended up
including neonates with gestational age 28 weeks and more.
3. In principle, we agree with the effect of
mother’s voice on the effect of pain. However, any randomized
control study requires that the intervention be standardized and not
changing. Using mother’s voice as an intervention is a pragmatic
approach and often not approved by reviewers. To ensure
standardization and generalizability of the study, music therapy was
selected. Using mother’s voice would have invited comments such as
duration, pitch, ethics of placing the burden of pain reduction on
voice modulation on mothers who themselves may be in pain.
4. Sarnat score [2] was used in the current
study, as it is one of the commonly used scores for hypoxic-ischemic
encephalopathy grading. It has been studied for applications other
than original description [3] and has been also proposed to be
useful in classifying hypoxic-ischemic encephalopathy in preterms
[4,5]. Currently, there is lack of well-researched scoring system in
preterm neonates and hence, we used Sarnat scoring despite its
original description being focused on neonates more than 36 weeks.
Additionally, we used Sarnat staging as an adjunct criteria in
conjunction with other signs of perinatal hypoxia (fetal bradycardia
and late decelarations) with intention to strengthen the exclusion
of those neonates who might have suffered severe intrapartum
hypoxia.
References
1. Shukla VV, Bansal S, Nimbalkar A, Chapla A, Phatak
A, Patel D, et al. Pain control interventions in preterm
neonates: A randomized controlled trial. Indian Pediatr. 2018;55:292-60.
2. Sarnat HB, Sarnat MS. Neonatal encephalopathy
following fetal distress: A clinical and electroencephalographic study.
Archives Neurol. 1976;33:696-705.
3. Shankaran S, Laptook AR, Ehrenkranz RA, Tyson JE,
McDonald SA, Donovan EF, et al. Whole-body hypothermia for
neonates with hypoxic–ischemic encephalopathy. New Eng J Med.
2005;353:1574-84.
4. Gopagondanahalli KR, Li J, Fahey MC, Hunt RW,
Jenkin G, Miller SL, et al. Preterm Hypoxic–ischemic
encephalopathy. Front Pediatr. 2016;4:114.
5. Chalak LF, Rollins N, Morriss MC, Brion LP, Heyne R, Sánchez PJ.
Perinatal acidosis and hypoxic-ischemic encephalopathy in preterm
infants of 33 to 35 weeks’ gestation. J Pediatr. 2012;160:388-94.
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