The burden of life-long disabilities arising from brain injury during newborn period is far higher in low- and middle-income countries than in high-income countries. The vast majority results from perinatal asphyxia or infection, and often a combination of these.

Whilst cooling therapy reduces death and disability after neonatal encephalopathy in high-income countries, the safety and efficacy of cooling therapy in low and middle-income countries in unknown. Over the past decade, our work has been focused on understanding brain injury after neonatal encephalopathy in low- and middle-income countries and evaluating the safety and efficacy of cooling therapy in these settings. We have set up a consortium of large perinatal centres in South Asia with facilities for 3 Tesla MR imaging and spectroscopy for conducting this work.

Group action


Ongoing studies

Hypothermia for Encephalopathy in Low and Middle Income Countries (HELIX) Trial (Funding: Gates Foundation and Weston Garfield Foundation)

Although cooling is the standard of care for neonatal encephalopathy in high-income countries, the safety and efficacy of cooling in low- and middle-income countries (LMICs) - which shoulder 99% of the disease burden - is unclear. A total of 408 encephalopathic babies will be randomised to cooling or usual care, from three countries (India, Sri Lanka and Bangladesh). Outcome measures are based on 3 Tesla MRI and MR spectroscopy at 2 weeks after birth, and death/neurodisability at 18 months after birth. HELIX is the largest ever cooling trial in the world, and the only such trial to use MR spectroscopy biomarkers across multi-vendor platforms.

Funding: Gates Foundation and Weston Garfield Foundation
Sponsor: Imperial College London

HELIX Trial Protocol
HELIX Parent Information Sheet - Hindi
HELIX Parent Information Sheet - Malayalam
HELIX Parent Information Sheet - Kanada
HELIX Parent Information Sheet - Bangala
HELIX Parent Information Sheet - Sinhala
HELIX Parent Information Sheet - Telugu
HELIX Parent Information Sheet - Tamil

helix

 
 
 
 
 
 
 
Recruiting Centres
NoHospitalCountryPrincipal InvestigatorMRI scanner
 1 Maulana Azad Medical College, NewDelhi  India  Professor Siddarth Ramji  3T Siemens
 2 Sion Medical College Hospital, Mumbai India  Professor Jayashree Mondhkar  3T Philips
 3 IndiraGandhi Institute of ChildHealth, Bangalore India  Dr Naveen Benkappa  3T Siemens
 4 Institute of ChildHealth, Madras Medical College India  Assoc Professor Mangalabharathi  3T Siemens
 5 Institute of Obstetrics & Gynaecology, Madras Medical College  India  Professor Aresar Seeralar  3T Siemens
 6 Trivandrum Medical College, Kerala India  Professor Shobha Kumar  3T GE
 7 Kelaniya University, Colombo Sri Lanka  Dr Ranmali Rodrigo  3T Siemens
 8 Bangabandhu Sheikh Mujib Medical University, Dhaka Bangladesh  Professor Mohamod Shahidullah  3T Siemens
Co-ordinating centre: Perinatal Trials Unit, Bangalore (Dr Ravi Swamy)
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