RT Journal Article SR Electronic T1 Effect of home-based newborn care on neonatal and infant mortality: a cluster randomised trial in India JF BMJ Global Health JO BMJ Global Health FD BMJ Publishing Group Ltd SP e000680 DO 10.1136/bmjgh-2017-000680 VO 5 IS 9 A1 Reeta Rasaily A1 NC Saxena A1 Sushma Pandey A1 Bishan S Garg A1 Saraswati Swain A1 Sharad D Iyengar A1 Vinita Das A1 Sheela Sinha A1 Subodh Gupta A1 Anju Sinha A1 Shiv Kumar A1 Arvind Pandey A1 Ravindra Mohan Pandey A1 Harshpal Singh Sachdev A1 Mari Jeeva Sankar A1 Siddarth Ramji A1 Vinod K Paul A1 Abhay T Bang A1 , YR 2020 UL http://gh.bmj.com/content/5/9/e000680.abstract AB Background Home-based newborn care has been found to reduce neonatal mortality in rural areas. Study evaluated effectiveness of home-based care delivered by specially recruited newborn care workers- Shishu Rakshak (SR) and existing workers- anganwadi workers (AWW) in reducing neonatal and infant mortality rates.Methods This three-arm, community-based, cluster randomised trial was conducted in five districts in India. Intervention package consisted of pregnancy surveillance, health education, care at birth, care of normal/low birthweight neonates, identification and treatment of sick neonates and young infants using oral and injectable antibiotics and community mobilisation. The package was similar in both intervention arms—SR and AWW; difference being healthcare provider. The control arm received routine health services from the existing health system. Primary outcomes were neonatal and young infant mortality rates at ‘endline’ period (2008–2009) assessed by an independent team from January to April 2010 in the study clusters.Findings A total of 6623, 6852 and 5898 births occurred in the SR, AWW and control arms, respectively, during the endline period; the proportion of facility births were 69.0%, 64.4% and 70.6% in the three arms. Baseline mortality rates were comparable in three arms. During the endline period, the risk of neonatal mortality was 25% lower in the SR arm (adjusted OR 0.75, 95% CI 0.57 to 0.99); the risks of early neonatal mortality, young infant mortality and infant mortality were also lower by 32%, 27%, and 33%, respectively. The risks of neonatal, early neonatal, young infant, infant mortality in the AWW arm were not different from that of the control arm.Interpretation Home-based care is effective in reducing neonatal and infant mortality rates, when delivered by a dedicated worker, even in settings with high rates of facility births.Trial registration number The study was registered with Clinical Trial Registry of India (CTRI/2011/12/002181).