| Methods |
Cluster‐randomised trial |
| Participants |
Birth attendants from 6 countries (Argentina, Democratic Republic of Congo, Guatemala, India, Pakistan, Zambia), which included traditional birth attendants, nurses, midwives and physicians |
| Interventions |
A modified version of the NRP was provided in a cluster‐randomised design (after Early Newborn Care). NRP course consisted of in‐depth, hands on training in basic knowledge and skills of resuscitation, including initial steps, bag‐and‐mask ventilation but did not include training in chest compressions, endotracheal intubation or administration of medications |
| Outcomes |
Early neonatal mortality was defined as rate of death from all causes in the first 7 days after birth. Secondary outcomes included death attributable to birth asphyxia (defined as failure to initiate or sustain normal breathing at birth, as assessed by the birth attendant), overall stillbirth rate and fresh stillbirth rate (defined as absence of maceration), perinatal death rate, death in first 24 hours after birth, 1‐ and 5‐minute Apgar (dichotomised as < 4 or ≥ 4), use of resuscitation techniques, neurological outcome at 7 days as assessed by examination |
| Notes |
Large NICHD sponsored study by the Global Network for Women's and Children's Research (First Breath Study Group) in neonates born at or above 1500 g. ICC was requested and obtained from the author (ICC = 0.002) |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Cluster‐randomisation method not stated. Not sure if recruitment to the clusters would be different if the type of cluster already known |
| Allocation concealment (selection bias) |
Low risk |
Not relevant as the randomisation occurred at the cluster level and occurred at 1 time point |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Not applicable |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Trained birth attendants collected data but not clear if blinded |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Outcome data was available for 99.2% of all births |
| Selective reporting (reporting bias) |
Low risk |
All specified outcomes were 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 |
