Wiener 1977a.
Methods | Randomised controlled trial | |
Participants | 28 newborn infants, of gestation 38 to 42 weeks, 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 = 10 2. Normal saline placebo: n = 18 |
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Outcomes | Alveolar carbon dioxide tension, carbon dioxide excretion, alveolar ventilation, feeding behaviour, and habituation to a sound‐specific stimulus up to 48 hours of life | |
Notes | NICU, Wales, mid 1970s | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random allocation in pharmacy |
Allocation concealment (selection bias) | Low risk | Coded ampoules |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Naloxone or normal saline were "chosen blind at random" |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Likely to have been blinded but not stated explicitly either way in the paper |
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 | Unclear risk | The study was stopped early because the randomisation code was broken after 28 infants had been enrolled. |