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Hypothermia for moderate or severe neonatal encephalopathy in low-income and middle-income countries (HELIX): a randomised controlled trial in India, Sri Lanka, and Bangladesh

التفاصيل البيبلوغرافية
العنوان: Hypothermia for moderate or severe neonatal encephalopathy in low-income and middle-income countries (HELIX): a randomised controlled trial in India, Sri Lanka, and Bangladesh
المؤلفون: Thayyil, S, Pant, S, Montaldo, P, Shukla, D, Oliveira, V, Ivain, P, Bassett, P, Swamy, R, Mendoza, J, Moreno-Morales, M, Lally, PJ, Benakappa, N, Bandiya, P, Shivarudhrappa, I, Somanna, J, Kantharajanna, UB, Rajvanshi, A, Krishnappa, S, Joby, PK, Jayaraman, K, Chandramohan, R, Kamalarathnam, CN, Sebastian, M, Tamilselvam, IA, Rajendran, UD, Soundrarajan, R, Kumar, V, Sudarsanan, H, Vadakepat, P, Gopalan, K, Sundaram, M, Seeralar, A, Vinayagam, P, Sajjid, M, Baburaj, M, Murugan, KD, Sathyanathan, BP, Kumaran, ES, Mondkar, J, Manerkar, S, Joshi, AR, Dewang, K, Bhisikar, SM, Kalamdani, P, Bichkar, V, Patra, S, Jiwnani, K, Shahidullah, M, Moni, SC, Jahan, I, Mannan, MA, Dey, SK, Nahar, MN, Islam, MN, Shabuj, KH, Rodrigo, R, Sumanasena, S, Abayabandara-Herath, T, Chathurangika, GK, Wanigasinghe, J, Sujatha, R, Saraswathy, S, Rahul, A, Radha, SJ, Sarojam, MK, Krishnan, V, Nair, MK, Devadas, S, Chandriah, S, Venkateswaran, H, Burgod, C, Chandrasekaran, M, Atreja, G, Muraleedharan, P, Herberg, JA, Kling Chong, WK, Sebire, NJ, Pressler, R, Ramji, S, Shankaran, S
المصدر: The Lancet Global Health , 9 (9) e1273-e1285. (2021)
سنة النشر: 2021
المجموعة: University College London: UCL Discovery
الوصف: Background: Although therapeutic hypothermia reduces death or disability after neonatal encephalopathy in high-income countries, its safety and efficacy in low-income and middle-income countries is unclear. We aimed to examine whether therapeutic hypothermia alongside optimal supportive intensive care reduces death or moderate or severe disability after neonatal encephalopathy in south Asia. Methods: We did a multicountry open-label, randomised controlled trial in seven tertiary neonatal intensive care units in India, Sri Lanka, and Bangladesh. We enrolled infants born at or after 36 weeks of gestation with moderate or severe neonatal encephalopathy and a need for continued resuscitation at 5 min of age or an Apgar score of less than 6 at 5 min of age (for babies born in a hospital), or both, or an absence of crying by 5 min of age (for babies born at home). Using a web-based randomisation system, we allocated infants into a group receiving whole body hypothermia (33·5°C) for 72 h using a servo-controlled cooling device, or to usual care (control group), within 6 h of birth. All recruiting sites had facilities for invasive ventilation, cardiovascular support, and access to 3 Tesla MRI scanners and spectroscopy. Masking of the intervention was not possible, but those involved in the magnetic resonance biomarker analysis and neurodevelopmental outcome assessments were masked to the allocation. The primary outcome was a combined endpoint of death or moderate or severe disability at 18–22 months, assessed by the Bayley Scales of Infant and Toddler Development (third edition) and a detailed neurological examination. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, NCT02387385. Findings: We screened 2296 infants between Aug 15, 2015, and Feb 15, 2019, of whom 576 infants were eligible for inclusion. After exclusions, we recruited 408 eligible infants and we assigned 202 to the hypothermia group and 206 to the control group. Primary outcome data were available for 195 (97%) of the ...
نوع الوثيقة: article in journal/newspaper
وصف الملف: text
اللغة: English
Relation: https://discovery.ucl.ac.uk/id/eprint/10133662/1/Helix%202021.pdf; https://discovery.ucl.ac.uk/id/eprint/10133662/
الاتاحة: https://discovery.ucl.ac.uk/id/eprint/10133662/1/Helix%202021.pdf
https://discovery.ucl.ac.uk/id/eprint/10133662/
Rights: open
رقم الانضمام: edsbas.7C4D0B28
قاعدة البيانات: BASE
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