Degefie 2017.

Methods	The study was a cluster‐randomised controlled trial conducted from July 2011 to June 2013. The study took place in three rural areas of Ethiopia. Twenty‐two clusters, each with approximately 1000 births annually, were randomly assigned to the intervention or control arm. In both arms, postnatal home visits were conducted to provide counselling and neonatal assessment. In the intervention arm, infants with a PSBI received antibiotics at a health post if referral to a facility was refused, and infants with a PSBI in the control arm were only offered referral to a facility. The home visits and interventions were provided by health education workers who are women with 10th grade education and additional one year of focused training.
Participants	Neonates (aged 0 to 27 days) were identified as having a PSBI in both arms by health education workers at health posts. Any one of the following classified an infant as having a PSBI: convulsions, poor feeding, fast breathing, respiratory distress, lethargy, hypo/hyperthermia.
Interventions	Neonates in both arms were referred to an inpatient facility. If families in the intervention arm refused, neonates were provided seven days of oral amoxicillin 40 mg/kg three times daily and intramuscular gentamicin 3 mg/kg to 7.5 mg/kg daily. The oral amoxicillin was administered by the neonate's caregivers and the intramuscular gentamicin was administered by health education workers.
Outcomes	Primary outcome: all‐cause neonatal morality, restricted to death on days 2 to 27 after birth. Neonatal mortality was measured by household survey data
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Comment: insufficient explanation of randomisation process
Allocation concealment (selection bias)	Low risk	Comment: since it was a 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	Quotes: "...survey teams were blinded to minimize interviewer bias." Comment: personnel assessing the outcomes were sufficiently blinded
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: there were similar rates of attrition in the intervention and control arm. In the intervention arm, 6% of allocated households were not included in the final analysis. In the control arm, 8% of allocated households were not included in the final analysis
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: NCT00743691
Other bias	Unclear risk	Contamination bias: Comment: no information is provided about risk of contamination bias