This refers to the large multicentric trial conducted in India, and
recently published in Indian Pediatrics [1]. I have few concerns
related to this paper. To begin with, the ambient temperature in the
neonatal intensive care unit (NICU) in any of the centers was not
mentioned in the study, which is very important for the Phase changing
material (PCM) to work effectively [2]. The time taken to reach the
target temperature was longer (120 minutes) but the fluctuation was less
(0.39) in this study as compared to other large trials. The mean age of
initiation of cooling (2.9 hours) was impressive as average time taken
to reach hospital in out-born babies in Indian scenario ranges from
2-5.6 hours [3], and less than 30% of babies reach within 6 hours of
life [4]. It would be worth knowing the number of inborn and out-born
babies in each center. Three out of 103 babies with mild encephalopathy
were cooled when they were not eligible for the intervention.
The discussion of the study mentions that it had only
10% (results showed nearly 19%) of babies with severe encephalopathy as
compared to 60% in TOBY trial [5], which is a huge difference as we know
that babies with severe insult have multiorgan dysfunction creating
doubts about authors’ claims of PCM to be safe and feasible. Lastly, the
study was partly funded by a manufacturer of PCM, which could have
possibly, but not necessarily, influenced the interpretation of study
results. It also raises the question when the results mention that PCM
is comparable to servo-controlled equipment in maintaining target
temperature, when this study has not directly compared to this
intervention with servo-controlled devices.
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;55:201-6.
2. Thayyil S, Shankaran S, Wade A, Cowan FM, Ayer M,
Satheesan K, et al. Whole-body cooling in neonatal encephalopathy
using phase changing material. Arch Dis Child Fetal Neonatal Ed.
2013;98:F280-1.
3. Narang M, Kaushik JS, Sharma AK, Faridi
MM. Predictors of mortality among the neonates transported to referral
centre in Delhi, India. Indian J Public Health. 2013;57: 100-10.
4. Rathod D, Adhisivam B, Vishnu Bhat B. Transport of
sick neonates to a tertiary care hospital, south India: Condition at
arrival and outcome. Trop Doctor. 2015;45:96.
5. 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.