Kumar 2008.

Methods	Parallel 3‐arm cluster‐RCT conducted in India between Jan 2004 and May 2005.
Participants	Sample size: 39 clusters (3891 individuals analysed). Clusters: administrative units. Individuals: all mothers who had delivered during the study period and were available for interview.
Interventions	Target: health system (home visits) and community (IEC). Arm 1 (13 clusters): a preventive package of interventions for essential newborn care (birth preparedness, clean delivery and cord care, thermal care [including skin‐to‐skin care], breastfeeding promotion, and danger sign recognition). The strategy included 2 prenatal (60 days and 30 days before expected date of delivery) and 2 postnatal (day 0 and day 3) home visits, community meetings and folk‐song meetings, maternal and newborn health stakeholder meetings, and meetings for community volunteers. Arm 2 (13 clusters): received same package of essential newborn care plus use of a liquid crystal hypothermia indicator (ThermoSpot; a sticker that indicates hypothermia in the newborn by changing colour). Arm 3 (13 clusters): received the standard care available from government and NGO providers in the area.
Outcomes	Trial primary outcome: newborn care practices and neonatal mortality rate. Review outcomes reported: Primary: not reported. Secondary: maternal mortality (up to 6 weeks postpartum), ANC coverage (at least 1 visit), health facility deliveries, tetanus protection, stillbirths, neonatal mortality. Other: essential newborn care measures, breastfeeding. Follow‐up: 2 prenatal assessments at 60 days and 30 days before expected date of delivery; 2 postnatal assessments at day 0 and day 3.
Notes	Funders: The United States Agency for International Development, Delhi Mission, and the Saving Newborn Lives program of Save the Children US through a grant from the Bill and Melinda Gates Foundation. Perinatal mortality included neonatal deaths up to 28 days after birth.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Stratified cluster‐randomisation conducted at Johns Hopkins University using a computer program.
Allocation concealment (selection bias)	Low risk	Allocation performed remotely.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Blinding not possible.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Preliminary analysis (2005) of neonatal mortality rate was said to be masked.
Recruitment bias (for cluster RCTs)	Low risk	None noted.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Loss to follow‐up described in study flow diagram with missing data < 20%.
Selective reporting (reporting bias)	Low risk	Relevant outcomes reported.
Analysis bias	Low risk	Analysis appropriate for clusters; no ICC reported; ITT analysis performed.
Other bias	Low risk	No baseline imbalances.
Overall risk assessment	Low risk	No serious risk of bias concerns.