| Methods |
Cluster‐randomised trial |
| Participants |
Traditional birth attendants in Lufwanyama district of Zambia |
| Interventions |
Modified version of NRP. All participants were trained in drying the infant, suctioning the mouth and nose and optimally positioning the airway. The intervention arm were trained to stimulate babies by gently rubbing their back or feet, and to provide PPV with a reusable resuscitator mask. Intervention birth attendants were also trained to recognise cardinal symptoms and signs of infection, and, if present, to administer oral amoxicillin and transfer to a hospital setting. They also received a laminated reference card summarising the neonatal resuscitation protocol and the trigger conditions for antibiotics with facilitated referral |
| Outcomes |
The primary outcome was the proportion of liveborn infants who died in the first 28 days after birth. Other outcomes included proportion of stillbirths, early neonatal death (< 1 week), late neonatal mortality from day 8 to 28 |
| Notes |
ICC was not available and hence ICC of 0.002 from the Carlo 2010a; Carlo 2010b study was used in the meta‐analysis |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Public ceremony where birth attendant took a slip from a box to determine group assignment |
| Allocation concealment (selection bias) |
Low risk |
Not relevant as this was a cluster‐randomised trial and all randomisation occurred at 1 time point |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Possibility of overlap across rural areas |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Independently reviewed by 3 Boston neonatologists unaware of group assignment |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
98.3% contributed valid data |
| Selective reporting (reporting bias) |
Low risk |
All specified outcomes reported |
| Other bias |
Low risk |
No loss of clusters were reported, analyses was appropriate taking clustering into account and clusters were similar with no baseline imbalance |
