Evans 1976.
Methods | Randomised controlled trial | |
Participants | 44 newborn infants, of gestation 38 to 42 weeks, delivered spontaneously or by forceps, whose mothers had been given pethidine in labour | |
Interventions | 1. Naloxone administered via the umbilical vein at 1 minute of age (0.04 mg total): n = 20 2. No drug: n = 24 |
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Outcomes | Time to first breath, time to onset of sustained respiration, Apgar score at 5 minutes, alveolar carbon dioxide tension, alveolar ventilation, and ventilation rate at 10 minutes and 30 minutes of life | |
Notes | NICU, Wales, mid 1970s | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Described as "randomly allocated", no further details reported |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Unblinded |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Unblinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Complete follow‐up |
Selective reporting (reporting bias) | Unclear risk | No protocol (though no reason to suspect selective reporting) |
Other bias | Low risk | No reason to suspect any other bias |