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.
Ongoing studies
Hypothermia for Encephalopathy in Low and Middle Income Countries (HELIX) Trial (Funding: NIHR 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.
See the HELIX trial video on the last trial baby (No:408) (Recruited in Feb 2019)
HELIX Trial
Bayley assessment of the final (408) baby at Bangalore at the roof top in a remote village in Karnataka (Sept 2020)
HELIX Trial Part 2
Funding: NIHR 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
Please see the PREVENT study website for more details
Summary of the PREVENT study (watch the video link below: Courtesy Sandhya Ramesh, PRINT, Bangalore)