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1. Parental and professional perceptions of informed consent and participation in a time-critical neonatal trial: a mixed-methods study in India, Sri Lanka and Bangladesh

Author

Vânia Oliveira, Jagadish Somanna, Jayashree Mondkar, Swati Manerkar, Mangalabharathi Sundaram, Paolo Montaldo, Josephine Mendoza, Paul Bassett, Siddarth Ramji, Seetha Shankaran, Sudhin Thayyil, Kerry Woolfall, Ismat Jahan, Mohammod Shahidullah, Rema Chandramohan, Monica Sebastian, Arasar Seeralar, Mohamed Sajjid, Ranmali Rodrigo, Samanmali Sumanasena, Stuti Pant, Naveen Benakappa, Samanmali P Sumanasena, Maya Annie Elias, Maria Moreno Morales, Bensitta Lincy, Chinnathambi N Kamalarathnam, Indramma Shivarudhrappa, Kumutha Jayaraman, Mythili Baburaj, Prathik Bandiya, Prakash Vinayagam, Radhika Sujatha, Sadeka C Moni, and Saritha J Radha

Subjects
Medicine (General), R5-920, Infectious and parasitic diseases, RC109-216
Abstract

Introduction Time-critical neonatal trials in low-and-middle-income countries (LMICs) raise several ethical issues. Using a qualitative-dominant mixed-methods design, we explored informed consent process in Hypothermia for encephalopathy in low and middle-income countries (HELIX) trial conducted in India, Sri Lanka and Bangladesh.Methods Term infants with neonatal encephalopathy, aged less than 6 hours, were randomly allocated to cooling therapy or usual care, following informed parental consent. The consenting process was audio-video (A-V) recorded in all cases. We analysed A-V records of the consent process using a 5-point Likert scale on three parameters—empathy, information and autonomy. In addition, we used exploratory observation method to capture relevant aspects of consent process and discussions between parents and professionals. Finally, we conducted in-depth interviews with a subgroup of 20 parents and 15 healthcare professionals. A thematic analysis was performed on the observations of A-V records and on the interview transcripts.Results A total of 294 A-V records of the HELIX trial were analysed. Median (IQR) score for empathy, information and autonomy was 5 (0), 5 (1) and 5 (1), respectively. However, thematic analysis suggested that the consenting was a ceremonial process; and parental decision to participate was based on unreserved trust in the treating doctors, therapeutic misconception and access to an expensive treatment free of cost. Most parents did not understand the concept of a clinical trial nor the nature of the intervention. Professionals showed a strong bias towards cooling therapy and reported time constraints and explaining to multiple family members as key challenges.Conclusion Despite rigorous research governance and consent process, parental decisions were heavily influenced by situational incapacity and a trust in doctors to make the right decision on their behalf. Further research is required to identify culturally and context-appropriate strategies for informed trial participation.

Published
2021
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2. Hypothermia for moderate or severe neonatal encephalopathy in low and middle-income countries (HELIX): a randomised control trial in India, Sri Lanka and Bangladesh

Author

Sudhin Thayyil, Stuti Pant, Paolo Montaldo, Deepika Shukla, Vania Oliveira, Phoebe Ivain, Paul Bassett, Ravi Swamy, Josephine Mendoza, Maria Moreno-Morales, Peter J Lally, Naveen Benakappa, Prathik Bandiya, Indramma Shivarudhrappa, Jagadish Somanna, Usha B Kantharajanna, Ankur Rajvanshi, Sowmya Krishnappa, Poovathumkal K Joby, Kumutha Jayaraman, Rema Chandramohan, Chinnathambi N Kamalarathnam, Monica Sebastian, Indumathi A Tamilselvam, Usha D Rajendran, Radhakrishnan Soundrarajan, Vignesh Kumar, Harish Sudarsanan, Padmesh Vadakepat, Kavitha Gopalan, Mangalabharathi Sundaram, Arasar Seeralar, Prakash Vinayagam, Mohamed Sajjid, Mythili Baburaj, Kanchana D Murugan, Babu P Sathyanathan, Elumalai S Kumaran, Jayashree Mondkar, Swati Manerkar, Anagha R Joshi, Kapil Dewang, Swapnil M Bhisikar, Pavan Kalamdani, Vrushali Bichkar, Saikat Patra, Kapil Jiwnani, Mohammod Shahidullah, Sadeka C Moni, Ismat Jahan, Mohammad A Mannan, Sanjoy K Dey, Mst N Nahar, Mohammad N Islam, Kamrul H Shabuj, Ranmali Rodrigo, Samanmali Sumanasena, Thilini Abayabandara-Herath, Gayani K Chathurangika, Jithangi Wanigasinghe, Radhika Sujatha, Sobhakumar Saraswathy, Aswathy Rahul, Saritha J Radha, Manoj K Sarojam, Vaisakh Krishnan, Mohandas K Nair, Sahana Devadas, Savitha Chandriah, Harini Venkateswaran, Constance Burgod, Manigandan Chandrasekaran, Gaurav Atreja, Pallavi Muraleedharan, Jethro A Herberg, W K Kling Chong, Neil J Sebire, Ronit Pressler, Siddarth Ramji, Seetha Shankaran, Peter J. Lally, Usha B. Kantharajanna, Poovathumkal K. Joby, Chinnathambi N. Kamalarathnam, Indumathi Tamilselvam, Ushadevi Rajendran, Kanchana D. Murugan, Babu P. Sathyanathan, Elumalai S. Kumaran, Anagha R. Joshi, Swapnil M. Bhisikar, Sadeka C. Moni, Mohammad A. Mannan, Sanjoy K. Dey, Mst. N. Nahar, Manoj K. Sarojam, Mohandas K. Nair, Jethro A. Herberg, WK 'Kling' Chong, Neil J. Sebire, Medical Research Council (MRC), and National Institute for Health Research

Subjects
Male, Pediatrics, medicine.medical_specialty, India, Bayley Scales of Infant Development, Severity of Illness Index, law.invention, 1117 Public Health and Health Services, Randomized controlled trial, law, Hypothermia, Induced, Intensive care, Severity of illness, medicine, Humans, Developing Countries, Sri Lanka, Bangladesh, Brain Diseases, Intention-to-treat analysis, Neonatal encephalopathy, business.industry, Infant, Newborn, General Medicine, Articles, medicine.disease, HELIX consortium, Treatment Outcome, Relative risk, Intensive Care, Neonatal, Apgar score, Female, business, 0605 Microbiology
Abstract

Summary Background Although therapeutic hypothermia reduces death or disability after neonatal encephalopathy in high-income countries, its safety and efficacy in low-income and middle-income countries is unclear. We aimed to examine whether therapeutic hypothermia alongside optimal supportive intensive care reduces death or moderate or severe disability after neonatal encephalopathy in south Asia. Methods We did a multicountry open-label, randomised controlled trial in seven tertiary neonatal intensive care units in India, Sri Lanka, and Bangladesh. We enrolled infants born at or after 36 weeks of gestation with moderate or severe neonatal encephalopathy and a need for continued resuscitation at 5 min of age or an Apgar score of less than 6 at 5 min of age (for babies born in a hospital), or both, or an absence of crying by 5 min of age (for babies born at home). Using a web-based randomisation system, we allocated infants into a group receiving whole body hypothermia (33·5°C) for 72 h using a servo-controlled cooling device, or to usual care (control group), within 6 h of birth. All recruiting sites had facilities for invasive ventilation, cardiovascular support, and access to 3 Tesla MRI scanners and spectroscopy. Masking of the intervention was not possible, but those involved in the magnetic resonance biomarker analysis and neurodevelopmental outcome assessments were masked to the allocation. The primary outcome was a combined endpoint of death or moderate or severe disability at 18–22 months, assessed by the Bayley Scales of Infant and Toddler Development (third edition) and a detailed neurological examination. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov , NCT02387385 . Findings We screened 2296 infants between Aug 15, 2015, and Feb 15, 2019, of whom 576 infants were eligible for inclusion. After exclusions, we recruited 408 eligible infants and we assigned 202 to the hypothermia group and 206 to the control group. Primary outcome data were available for 195 (97%) of the 202 infants in the hypothermia group and 199 (97%) of the 206 control group infants. 98 (50%) infants in the hypothermia group and 94 (47%) infants in the control group died or had a moderate or severe disability (risk ratio 1·06; 95% CI 0·87–1·30; p=0·55). 84 infants (42%) in the hypothermia group and 63 (31%; p=0·022) infants in the control group died, of whom 72 (36%) and 49 (24%; p=0·0087) died during neonatal hospitalisation. Five serious adverse events were reported: three in the hypothermia group (one hospital readmission relating to pneumonia, one septic arthritis, and one suspected venous thrombosis), and two in the control group (one related to desaturations during MRI and other because of endotracheal tube displacement during transport for MRI). No adverse events were considered causally related to the study intervention. Interpretation Therapeutic hypothermia did not reduce the combined outcome of death or disability at 18 months after neonatal encephalopathy in low-income and middle-income countries, but significantly increased death alone. Therapeutic hypothermia should not be offered as treatment for neonatal encephalopathy in low-income and middle-income countries, even when tertiary neonatal intensive care facilities are available. Funding National Institute for Health Research, Garfield Weston Foundation, and Bill & Melinda Gates Foundation. Translations For the Hindi, Malayalam, Telugu, Kannada, Singhalese, Tamil, Marathi and Bangla translations of the abstract see Supplementary Materials section.

Published
2021

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