Global perinatal neuroscience
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.
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
|No||Hospital||Country||Principal Investigator||MRI 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)|
Prevention of Epilepsy by reducing Neonatal Encephalopathy (PREVENT) study - funding: NIHR
The PREVENT study will be co-ordinated by the Perinatal Trials Unit Foundation, Bangalore.
More details coming soon