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 co

SUBMITTER: Thayyil S 

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

REPOSITORIES: biostudies-literature