Rise and Fall of Therapeutic Hypothermia in Low-Resource Settings: Lessons from the HELIX Trial: Correspondence

Abstract

1. It is well known that incidence of birth asphyxia is high in Indian subcontinent and studies from different parts of the country published in reputed peer-reviewed journals have shown that therapeutic hypothermia is effective in the management of hypoxic–ischemic encephalopathy due to perinatal asphyxia. Many centers caring for sick newborns have adopted therapeutic hypothermia [2] with success and would dread the scenario of managing eligible asphyxiated neonates sans therapeutic hypothermia. 2. We have studied the online version of HELIX trial and the study states that “therapeutic hypothermia alongside optimal tertiary neonatal intensive care do not reduce brain injury on MRI, nor improve the combined outcomes of death or disability after neonatal encephalopathy in LMICs.” This is contrary to the ground reality. Some trial centers do not have adequate facilities, as stated in social media by one of the principle investigators of the study from a recruiting center. 3. The recruited centers in this study are not representative of the neonatal intensive care facilities available in this country; 59.9% weightage of the study is from two centers in public sector. Yet, the authors have chosen to generalize the findings to all LMIC countries. To claim generalizability of the data when bulk of the information has been collected from just a couple of centers is in conflict with scientific sense. 4. The title “Rise and Fall of Therapeutic Hypothermia in Low-Resource Settings: Lessons from the HELIX Trial” is deceptive, as HELIX trial NEVER followed the usage of therapeutic hypothermia in neonatal centers across India. Rather, with just 408 subjects recruited from few centers, the authors have chosen to write the obituary of therapeutic hypothermia in India and other LMIC countries. 5. Feasibility trials, 2 from one center and 1 from 10 centers across India (multicentric) have shown that low-cost devices including frozen gel pack (FGM), and phasechanging material (PCM) were safe and feasible [3–5]. Many centers continue to use low-cost devices, not servo-controlled machines, for provision of therapeutic hypothermia, and hence, the statement “Despite these concerns PCM was marketed” by the authors makes no sense. 6. The authors have stated that “The good outcomes reported earlier could be due to inclusion of infants with no or mild encephalopathy.” This is based on conjecture rather than evidence. To assume that studies, which have reported outcomes different from the authors’ study, have faulty design or recruitment is reckless. Such assumptions by itself do not invalidate other studies. It is disappointing that the editorial board had allowed such unscientific statements to be published in a highly reputable journal like Indian Journal of Pediatrics. 7. The authors once again chose to mention about “14 singlecentered pilot trials so far from LMIC” with Poor Trial Designs. If this was the case indeed, it is odd that the authors chose to include them in his prior metaanalysis [6]. 8. It is extremely sad to see that the reputed authors have chosen to use offensive language throughout the arti* Tiroumourougane V. Serane [email protected]