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

Jayaraj, Dhanya; Rajendran, Srijithesh

doi:10.1007/s12098-021-03962-8

Indian J Pediatr

2021

DOI: 10.1007/s12098-021-03962-8

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

Dhanya Jayaraj

Srijithesh Rajendran

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“…In the letters to the editor of this journal it has been suggested that we were critical of research performed in India and other low and middle-income countries (LMICs), individuals performing the research, trial design, obtaining informed consent, reliability of data and research governance [3][4][5][6][7][8][9][10]. Our comments were not meant to be critical, and we apologize if our comments were offensive.…”

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

Thayyil

Shankaran

2021

Indian J Pediatr

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confidence: 99%

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

Thayyil

Shankaran

2021

Indian J Pediatr

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Exercise and Asana Yoga in Parkinson's Disease: A Critical Analysis of Evidence and Definition

Srijithesh

Mythirayee

2022

Neurol India

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Therapeutic hypothermia in neonatal hypoxic encephalopathy: A systematic review and meta-analysis

2022

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Background Therapeutic hypothermia (TH) is regarded as the most efficacious therapy for neonatal hypoxic encephalopathy. However, limitations in previous systematic reviews and the publication of new data necessitate updating the evidence. We conducted this up-to-date systematic review to evaluate the effects of TH in neonatal encephalopathy on clinical outcomes. Methods In this systematic review and meta-analysis, we searched Medline, Cochrane Library, Embase, LIVIVO, Web of Science, Scopus, CINAHL, major trial registries, and grey literature (from inception to October 31, 2021), for randomized controlled trials (RCT) comparing TH vs normothermia in neonatal encephalopathy. We included RCTs enrolling neonates (gestation ≥35 weeks) with perinatal asphyxia and encephalopathy, who received either TH (temperature ≤34°C) initiated within 6 hours of birth for ≥48 hours, vs no cooling. We excluded non-RCTs, those with delayed cooling, or cooling to >34°C. Two authors independently appraised risk-of-bias and extracted data on mortality and neurologic disability at four time points: neonatal (from randomization to discharge/death), infancy (18-24 months), childhood (5-10 years), and long-term (>10 years). Other outcomes included seizures, EEG abnormalities, and MRI findings. Summary data from published RCTs were pooled through fixed-effect meta-analysis. Results We identified 36 863 citations and included 39 publications representing 29 RCTs with 2926 participants. Thirteen studies each had low, moderate, and high risk-of-bias. The pooled risk ratios (95% confidence interval, CI) were as follows: neonatal mortality: 0.87 (95% CI = 0.75, 1.00), n = 2434, I 2 = 38%; mortality at 18-24 months: 0.88 (95% CI = 0.78, 1.01), n = 2042, I 2 = 51%; mortality at 5-10 years: 0.81 (95% CI = 0.62, 1.04), n = 515, I 2 = 59%; disability at 18-24 months: 0.62 (95% CI = 0.52, 0.75), n = 1440, I 2 = 26%; disability at 5-10 years: 0.68 (95% CI = 0.52, 0.90), n = 442, I 2 = 3%; mortality or disability at 18-24 months: 0.78 (95% CI = 0.72, 0.86), n = 1914, I 2 = 54%; cerebral palsy at 18-24 months: 0.63 (95% CI = 0.50, 0.78), n = 1136, I 2 = 39%; and childhood cerebral palsy: 0.63 (95% CI = 0.46, 0.85), n = 449, I 2 = 0%. Some outcomes showed significant differences by study-setting; the risk ratio (95% CI) for mortality at 18-24 months was 0.79 (95% CI = 0.66,0.93), n = 1212, I 2 = 7% in high-income countries, 0.67 (95% CI = 0.41, 1.09), n = 276, I 2 = 0% in upper-middle-income countries, and 1.18 (95% CI = 0.94, 1.47), n = ...

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

Cited by 3 publications

References 4 publications

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

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

Exercise and Asana Yoga in Parkinson's Disease: A Critical Analysis of Evidence and Definition

Therapeutic hypothermia in neonatal hypoxic encephalopathy: A systematic review and meta-analysis

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