Bhandari 2012.

Methods	The study was a cluster‐randomised controlled trial conducted from July 2007 to April 2010. The study took place in 18 communities in the district of Faridabad, Haryana, India and each community was randomised to either the intervention arm or the control arm. The intervention involved many types of health practitioners including physicians, nurses, community health workers and traditional birth attendants
Participants	Neonates (0 to 27 days) and infants (28 days to one year of life) who resided in the 18 study communities were included
Interventions	The intervention was the introduction of The Integrated Management of Neonatal and Childhood Illness (IMNCI). IMNCI includes three main components: Improvement in the case management skills of health staff Improvement in the overall health system to support its performance, and Improvement in family and community health care practices which include: prevention and management of hypothermia early initiation of breastfeeding and exclusive breastfeeding community‐based care of low birth weight infants improved care‐seeking for neonatal infections Neonates who lived in the intervention clusters and were identified as having a local infection (umbilicus red or draining pus, pus discharge from ear or skin pustules) were given five days of oral cotrimoxazole or amoxicillin. Those identified as having a PSBI were given the first dose of injectable benzylpenicillin and gentamicin by a community health worker and then referred to the hospital. If referral was not possible, efforts were made to continue antibiotic treatment in clinic or at home. The diagnosis of a PSBI was made if any of the following were present: convulsions; fast breathing; severe chest indrawing; grunting; nasal flaring; bulging fontanelle; multiple skin pustules; axillary temperature > 37.5°C or < 35.5°C; lethargy; less than normal movement
Outcomes	Primary outcomes: neonatal mortality (deaths between birth and day 27 of life), mortality beyond the first 24 hours of birth (deaths between day 1 and day 27 of life), and infant mortality (deaths between birth and 1 year of life) Secondary outcomes: newborn care practices and process of delivery of the intervention
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "We divided the clusters into three strata containing six clusters each according to their baseline neonatal mortality rate. An independent epidemiologist generated 10 stratified randomization schemes to allocate the clusters to intervention or control groups. We excluded three of these schemes, which had large differences in neonatal mortality rate, proportion of home births, proportion of mothers who had never been to school, and population size. We selected one of the remaining seven allocation schemes by a computer generated random number." Comment: there was appropriate random sequence generation
Allocation concealment (selection bias)	Low risk	Comment: since it was cluster‐randomised trial, all clusters were randomised at the same time
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Comment: the nature of the intervention made blinding of participants and personnel not feasible, but the outcome is not likely to be influenced by the lack of blinding
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "The surveillance team was not told the intervention status of the community they were visiting." Comment: personnel assessing the outcomes were sufficiently blinded
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: the intervention and control clusters had similar rates of attrition. In the intervention clusters, 37,741 pregnancies were identified of which 88% (33,091) of the outcomes were known. In the control clusters, 39,846 pregnancies were identified of which 86% (34,257) of the outcomes were known. In the intervention clusters, 29,782 live births were identified and less than 1% (115). were lost to follow‐up. In the control clusters, 30,920 live births were identified and less than 1% (107) were lost to follow‐up
Selective reporting (reporting bias)	Low risk	Comment: the trial was registered with a clinical trials registry and reported the outcomes identified in the study protocols Clinicaltrials.gov registry number: NCT00474981
Other bias	Low risk	Contamination bias: Quote: "Although contiguous, the 18 clusters are large and the way healthcare and worker responsibilities are organised within a primary health centre area makes the risk of contamination low."