Browsing by Author "Mangalabharathi, S."

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    Hypothermia for encephalopathy in low and middle-income countries (HELIX): study protocol for a randomised controlled trial
    (BioMed Central, 2017) 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
    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.