Hypothermia for Encephalopathy in Low and Middle-Income Countries Trial

Summary

Neonatal Encephalopathy is a serious condition arising from unexpected lack of cerebral blood flow and oxygen supply to the foetal brain at the time of birth. Every year, approximately one million babies die from neonatal encephalopathy in low and middle-income countries and a quarter of these deaths occur in India.

In the past decade, a number of clinical trials in high-income countries has shown that cooling therapy along with optimal neonatal intensive care reduces death and neurodisability after neonatal encephalopathy. Cooling therapy is now used as a standard therapy after neonatal encephalopathy in all high income countries, including the UK.

Although the burden of neonatal encephalopathy is far higher in low and middle-income countries, the safety and efficacy data on cooling therapy from high income cooling trials cannot be extrapolated to these settings, due to the difference in population co-morbidities and sub-optimal neonatal intensive care.

The HELIX trial proposes to examine whether whole body cooling to 33.5°C initiated within 6 hours of birth and continued for 72 hours reduces death or neurodisability at 18 months after neonatal encephalopathy in public sector neonatal units in India.

A total of 408 babies with moderate or severe neonatal encephalopathy will be recruited from the participating centres in India over an 18 to 24 month period. The babies will be randomly allocated to whole body cooling or usual care. The cooling therapy will be achieved using an approved cooling device (Tecotherm) that is already in clinical use in the UK and in India. MR imaging and spectroscopy will be performed at 1 week of age to examine the brain injury. Neurodevelopmental outcomes will be assessed at 18 months of age. Primary outcome measure is death or moderate/severe neurodisability at 18 months.

Conditions

• Neonatal Encephalopathy

Interventions

DEVICE

Whole body cooling (Tecotherm)

Whole body cooling to 33 to 34 C using Tecotherm

Sponsors & Collaborators

• Madras Medical College

  collaborator OTHER_GOV

• Indira Gandhi Medical College, Shimla

  collaborator OTHER

• Lokmanya Tilak Municipal Medical College and Hospital

  collaborator OTHER

• Imperial College London

  collaborator OTHER

• Maulana Azad Medical College

  collaborator OTHER

• Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

  collaborator OTHER

• University of Kelaniya

  collaborator OTHER

• Medical College Trivandrum

  collaborator OTHER

• Thayyil, Sudhin

  lead INDIV

Principal Investigators

• Sudhin Thayyil, PhD · Imperial College London

• Vania Oliveira, MSc · Imperial College London

• Seetha Shankaran, MD · Wayne State University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Max Age

6 Hours

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-08-31

Primary Completion

2020-09-30

Completion

2020-12-01

Countries

• Bangladesh
• India
• Sri Lanka

Study Locations