@article{Thayyil:2017:10.1186/s13063-017-2165-3,
author = {Thayyil, S and Oliveira, V and Lally, PJ and Swamy, R and Bassett, P and Chandrasekaran, M and Mondkar, J and Mangalabharathi, S and Benkappa, N and Seeralar, A and Shahidullah, M and Montaldo, P and Herberg, J and Manerkar, S and Kumaraswami, K and Kamalaratnam, C and Prakash, V and Chandramohan, R and Bandya, P and Mannan, MA and Rodrigo, R and Nair, M and Ramji, S and Shankaran, S and HELIX, Trial group},
doi = {10.1186/s13063-017-2165-3},
journal = {Trials},
title = {Hypothermia for encephalopathy in low and middle-income countries (HELIX): study protocol for a randomised controlled trial.},
url = {http://dx.doi.org/10.1186/s13063-017-2165-3},
volume = {18},
year = {2017}
}

Download

TY  - JOUR
AB  - 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-income countries (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. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02387385 . Registered on 27 February 2015.
AU  - Thayyil,S
AU  - Oliveira,V
AU  - Lally,PJ
AU  - Swamy,R
AU  - Bassett,P
AU  - Chandrasekaran,M
AU  - Mondkar,J
AU  - Mangalabharathi,S
AU  - Benkappa,N
AU  - Seeralar,A
AU  - Shahidullah,M
AU  - Montaldo,P
AU  - Herberg,J
AU  - Manerkar,S
AU  - Kumaraswami,K
AU  - Kamalaratnam,C
AU  - Prakash,V
AU  - Chandramohan,R
AU  - Bandya,P
AU  - Mannan,MA
AU  - Rodrigo,R
AU  - Nair,M
AU  - Ramji,S
AU  - Shankaran,S
AU  - HELIX,Trial group
DO  - 10.1186/s13063-017-2165-3
PY  - 2017///
SN  - 1745-6215
TI  - Hypothermia for encephalopathy in low and middle-income countries (HELIX): study protocol for a randomised controlled trial.
T2  - Trials
UR  - http://dx.doi.org/10.1186/s13063-017-2165-3
UR  - http://hdl.handle.net/10044/1/51157
VL  - 18
ER  - 

Download