| Methods |
A cluster‐randomised trial of maternity hospitals in France. The investigators aimed to determine whether in situ high‐fidelity simulation training (for ∼ 80% of the delivery room staff) improved neonatal resuscitation performed in the delivery room |
| Participants |
12 maternity hospitals in France. A random sample of 10 professionals in each unit was presented with 2 standardised scenarios played on a neonatal high‐fidelity simulator |
| Interventions |
The 12 maternity hospitals were randomly assigned to receive the intervention (a 4‐hour simulation training session delivered in situ for multidisciplinary groups of 6 professionals) or not receive it. All maternity hospitals were evaluated again at 3 months after the intervention |
| Outcomes |
After intervention, the videos of resuscitation performance was assessed by 2 neonatologists and assigned a technical score. The frequency of achieving a heart rate > 90 beats/minute and number of hazardous events were also assessed |
| Notes |
In situ simulation study in France belonging to the AURORE perinatal network using mannequins |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Sealed opaque envelopes randomised by an individual not involved in the study (? cluster‐randomised) |
| Allocation concealment (selection bias) |
Low risk |
Sealed opaque envelopes |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Not applicable |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
2 blinded neonatologists performed the assessment |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
All data reported |
| Selective reporting (reporting bias) |
Unclear risk |
All specified outcomes were reported |
| Other bias |
High risk |
Analyses was made at the participant level although the randomisation was performed at the maternity hospital level |
