Dataset Information

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

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-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.

SUBMITTER: Thayyil S

PROVIDER: S-EPMC5604260 | biostudies-literature | 2017 Sep

REPOSITORIES: biostudies-literature

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Publications

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

Thayyil Sudhin S Oliveira Vania V Lally Peter J PJ Swamy Ravi R Bassett Paul P Chandrasekaran Mani M Mondkar Jayashree J Mangalabharathi Sundaram S Benkappa Naveen N Seeralar Arasar A Shahidullah Mohammod M Montaldo Paolo P Herberg Jethro J Manerkar Swati S Kumaraswami Kumutha K Kamalaratnam Chinnathambi C Prakash Vinayagam V Chandramohan Rema R Bandya Prathik P Mannan Mohammod Abdul MA Rodrigo Ranmali R Nair Mohandas M Ramji Siddarth S Shankaran Seetha S

Trials 20170918 1

<h4>Background</h4>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.<h4>Methods</h4>W ...[more]

PMID: 28923118

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Dataset Information

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

Background

Methods

Discussion

Trial registration

Publications

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

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