Abstract
In their recently online-published Review Article, El-Dib included multiple critiques of our Randomized Controlled Trial (RCT) of Whole Body Hypothermia in Preterm Infants 33–35 Wks Gestation. We agree that more data from larger studies may help to further assess safety and efficacy of therapeutic hypothermia (TH) for infants 35 wks GA or less, provided that such studies are rigorously designed, implemented and reported. Given the results of our trial, the efficacy and safety of hypothermia in this population has not been established. Responses to many of the issues they raise about our trial are included. For now, the results of our RCT remain the best available data regarding therapeutic hypothermia in this population.
Impact
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This letter responds to issues raised by previously published review article (El-Dib et al.) in this journal. Most of the issues raised that were not included in primary manuscript of our published RCT are addressed. Despite the limitations of our randomized, controlled trial, it remains the best available data regarding therapeutic hypothermia in 33–35 weeks gestational age infants with hypoxic-ischemic encephalopathy and does not support effectiveness.
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References
El-Dib, M. et al. Benefits and risks of therapeutic hypothermia for hypoxic-ischemic encephalopathy in late preterm infants. Pediatr. Res. https://doi.org/10.1038/s41390-025-04428-9 (2025).
Faix, R. G. et al. Whole-body hypothermia for neonatal encephalopathy in preterm infants 33 to 35 weeks’ gestation. JAMA Pediatr. 179, 396–406 (2025).
El-Dib, M. & Inder, T. Data and analysis concerns in trial of whole-body hypothermia for neonatal encephalopathy in preterm infants. JAMA Pediatr. 179, 925 (2025).
Faix, R. G., Laptook, A. R. & Shankaran, S. Data and analysis concerns in trial of whole-body hypothermia for neonatal encephalopathy in preterm infants – reply. JAMA Pediatr. 179, 925–926 (2025).
Shankaran, S. et al. National institute of child health and human development neonatal research network. Whole body hypothermia for neonates with hypoxic-ischemic encephalopathy. NEJM 353, 1574–1584 (2005).
Schulz, K. F., Altman, D. G., Moher, D. for the CONSORT group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. BMJ. 340, https://doi.org/10.1136/bmj.c332 (2010).
Volpe, J. J. Neurology of the Newborn. 5th ed. Saunders Elsevier. 121–153 (2008).
Funding
Grants from the Eunice Kennedy Shriver National Institute of Child Health and Human Development: U10 HD27871, U10 HD53119, UG1 HD21364, UG1 HD21373, UG1 HD21385, UG1 HD27851, UG1 HD27853, UG1 HD27856, UG1 HD27880, UG1 HD27904, UG1 HD34216, UG1 HD36790, UG1 HD40492, UG1 HD40689, UG1 HD53089, UG1 HD53109, UG1 HD68244, UG1 HD68270, UG1 HD68278, UG1 HD68263, UG1 HD68284, UG1 HD87226, UG1 HD87229. Grants from the National Center for Advancing Translational Sciences: UL1 TR6, UL1 TR41, UL1 TR42, UL1 TR77, UL1 TR93, UL1 TR442, UL1 TR454, UL1 TR1117.
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Faix, R.G., Laptook, A.R., Shankaran, S. et al. Reply to: Benefits and risks of therapeutic hypothermia for hypoxic-ischemic encephalopathy in late preterm infants. Pediatr Res (2025). https://doi.org/10.1038/s41390-025-04675-w
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DOI: https://doi.org/10.1038/s41390-025-04675-w
