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Title: | Hypothermia for encephalopathy in low and middle-income countries (HELIX): study protocol for a randomised controlled trial |
Authors: | Thayyil, S. Oliveira, V. Lally, P.J. Swamy, R. Bassett, P. Chandrasekaran, M. Mondkar, J. Mangalabharathi, S. Benkappa, N. Seeralar, A. Shahidullah, M. Montaldo, P. Herberg, J. Manerkar, S. Kumaraswami, K. Kamalaratnam, C. Prakash, V. Chandramohan, R. Bandya, P. Mannan, M.A. Rodrigo, R. Nair, M. Ramji, S. Shankaran, S. HELIX Trial group |
Keywords: | Clinical Protocols Randomized Controlled Trial |
Issue Date: | 2017 |
Publisher: | BioMed Central |
Citation: | Trials.2017;18(1):432 |
Abstract: | BACKGROUND: Therapeutic hypothermia reduces death and disability after moderate or severe neonatal encephalopathy in high-income countries and is used as standard therapy in these settings. However, the safety and efficacy of cooling therapy in low- and middle-incomecountries (LMICs), where 99% of the disease burden occurs, remains unclear. We will examine whether whole body cooling reduces death or neurodisability at 18-22 months after neonatal encephalopathy, in LMICs. METHODS: We will randomly allocate 408 term or near-term babies (aged ≤ 6 h) with moderate or severe neonatal encephalopathy admitted to public sector neonatal units in LMIC countries (India, Bangladesh or Sri Lanka), to either usual care alone or whole-body cooling with usual care. Babies allocated to the cooling arm will have core body temperature maintained at 33.5 °C using a servo-controlled cooling device for 72 h, followed by re-warming at 0.5 °C per hour. All babies will have detailed infection screening at the time of recruitment and 3 Telsa cerebral magnetic resonance imaging and spectroscopy at 1-2 weeks after birth. Our primary endpoint is death or moderate or severe disability at the age of 18 months. DISCUSSION: Upon completion, HELIX will be the largest cooling trial in neonatal encephalopathy and will provide a definitive answer regarding the safety and efficacy of cooling therapy for neonatal encephalopathy in LMICs. The trial will also provide important data about the influence of co-existent perinatal infection on the efficacy of hypothermic neuroprotection. |
Description: | Indexed In MEDLINE |
URI: | http://repository.kln.ac.lk/handle/123456789/17674 |
ISSN: | 1745-6215 (Electronic) 1745-6215 (Linking) |
Appears in Collections: | Journal/Magazine Articles |
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