We thank the author for his comments related to our study [1]. The
ambient temperature in the neonatal intensive care units (NICUs) was not
systematically measured in the study. However, all the NICUs were
air-conditioned where the ambient temperature is maintained in the range
of 24-28°C.
The mean (SD) age of initiation of therapeutic
hypothermia (TH) in our study was 2.9 (1.9) hours. We do not have data
on the proportion of out born infants included in the study and on the
number of infants who could not be cooled due to admission after 6 hours
of life. However, most of the study infants were inborn and we included
only those outborn babies who reached within 6 hours after birth. It is
our experience that in the last few years, more babies with asphyxia are
being referred earlier and are reaching us within 6 hours as referring
hospitals are becoming aware of the fact that cooling is being offered
in our institutions. It is interesting that 76% of infants cooled in the
HELIX feasibility trial were out- born infants [2].
Though the protocol recruited only those with
moderate to severe encephalopathy, three babies were noted to have only
mild encephalopathy during data analyses. Such trial deviates are also
seen in the other major trials on TH, and is well-documented phenomenon
in literature [3].
Nineteen (18.4%) infants had severe encephalopathy in
our study. The figure of 10% in the discussion is a typographic error.
The fluctuation of the temperature during cooling phase (0.39ºC) in our
study was less when compared to the fluctuations reported by the TOBY
(0.5ºC) [4] and NICHD (0.45ºC) [5] trials using servo-controlled
equipment. The good temperature control and few complications seen in
this study suggest that cooling is safe and feasible in a NICU setting
in India. We agree with the authors that the results of our study cannot
be directly compared to those of NICHD and TOBY trials due to the
difference in the proportion of infants with severe encephalopathy.
However, this should not influence the safety and feasibility of TH,
which was the focus of our study.
Though the study was partly funded by the device
manufacturer, they had no input in study design, data accrual and
analysis, or manuscript preparation.
References
1. Thomas N, Abiramalatha T, Bhat V, Varanattu M, Rao
S, Wazir S, et al. Phase changing material for therapeutic
hypothermia in neonates with hypoxic ischemic encephalopathy - A
multi-centric study. Indian Pediatr. 2018;55:201-5.
2. Oliveira V, Kumutha JR, Narayanan E, Somanna J,
Benkappa N, Bandya P, et al. Hypothermia for encephalopathy in
low-income and middle-income countries: feasibility of whole-body
cooling using a low-cost servo-controlled device. BMJ Paediatr Open.
2018;2:e000245.
3. Jacobs SE, Morley CJ, Inder TE, Stewart MJ, Smith
KR, McNamara PJ, et al. Whole-body hypothermia for term and
near-term newborns with hypoxic-ischemic encephalopathy: A randomized
controlled trial. Arch Pediatr Adolesc Med. 2011;165:692.
4. Azzopardi DV, Strohm B, Edwards AD, Dyet L,
Halliday HL, Juszczak E, et al. Moderate hypothermia to treat
perinatal asphyxial encephalopathy. N Engl J Med. 2009;361:1349-58.
5. Shankaran S, Laptook AR, McDonald SA, Higgins RD,
Tyson JE, Ehrenkranz RA, et al. Temperature profile and outcomes
of neonates undergoing whole body hypothermia for neonatal
hypoxic-ischemic encephalopathy. Pediatr Crit Care Med. 2012;13:53-9.