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Indian Pediatr 2018;55: 347-348 |
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Current Status of Therapeutic Hypothermia in India: Few
Concerns: Authors Reply
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Sudhin Thayyil 1
and Seetha Shankaran2
1 Centre for
Perinatal Neuroscience, Department of Pediatrics,
Imperial College London, UK; and
2Department of Neonatal
Perinatal Medicine, Wayne State University, USA.
Email: 1
[email protected]
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We agree with the authors that there is insufficient evidence to support
the use of therapeutic hypothermia in low- and middle-income countries
[1], and randomized controlled trials are urgently required. We also
agree that the profile of mothers and infants with encephalopathy due to
hypoxia-ischemia may be different in high resource countries from those
in LMIC [2]. The aim of our survey was merely to highlight the
therapeutic creep of cooling therapy in Indian neonatal units, despite
lack of such evidence [3]. Given the recall bias and subjectivity of
web-based surveys, collection of specific details is unlikely to be
accurate, and hence we did not attempt to collect data on eligibility
criteria for cooling, morbidity and mortality and outcome of infants.
While blood gas based criteria may be useful, it may
not be available round the clock in most Indian neonatal units. However,
it is essential that a structured neurological examination is performed
to ensure babies have moderate or severe encephalopathy, and not mild
encephalopathy, before offering cooling therapy. The NICHD neurological
examination has been validated in Indian settings, and if performed
accurately, will identify these infants. Long term follow-up rates are
extremely poor in routine clinical settings in India to provide
meaningful outcome data.
The concerns raised by the authors regarding lack of
safety of cooling methods used in the Neonatal units in India and lack
of data on safety and efficacy of cooling when initiated after 6 hours
of age have been addressed in our manuscript [3]. The NICHD Neonatal
Research Network data from high-income countries on cooling for neonatal
encephalopathy between 6 and 24 hours of age was recently published [4].
A large phase III randomized controlled trial of
whole body cooling is currently ongoing in several public sector
tertiary neonatal units in India, Bangladesh and Sri Lanka [5]. All
recruited babies are having detailed neuro-developmental follow up at 18
months using Bayley III Infant and Toddler Assessment. Once completed,
this would be the largest ever cooling trial and should provide the
definitive answer for safety and efficacy of cooling therapy in these
settings. We agree, until these data are available, cooling therapy in
Indian neonatal units should be considered as experimental, and it may
be prudent to obtain informed parental consent after discussing the risk
benefits.
References
1. Pauliah SS, Shankaran S, Wade A, Cady EB, Thayyil
S. Therapeutic hypothermia for neonatal encephalopathy in low- and
middle-income countries: A systematic review and meta-analysis. PLoS
One. 2013;8:e58834.
2. Montaldo P, Pauliah SS, Lally PJ, Olson L, Thayyil
S. Cooling in a low-resource environment: lost in translation. Semin
Fetal Neonatal Med. 2015;20:72-9.
3. Chandrasekaran M, Swamy R, Ramji S, Shankaran S,
Thayyil S. Therapeutic hypothermia for neonatal encephalopathy in Indian
neonatal units: A survey of national practices. Indian Pediatr.
2017;54:969-70.
4. Shankaran S, Laptook AR, Pappas A, McDonald
SA, Das A, Tyson JE, et al. Effect of depth and duration of
cooling on death or disability at age 18 months among neonates with
hypoxic-ischemic encephalopathy: A randomized clinical trial. JAMA.
2017;318:57-67.
5. Thayyil S, Oliveira V, Lally PJ, Swamy R, Bassett
P, Chandrasekaran M, et al. Hypothermia for encephalopathy in low
and middle-income countries (HELIX): study proto-col for a randomised
controlled trial. Trials. 2017;18:432.
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