Gerhardt 1977.
Methods | Randomised controlled trial | |
Participants | 20 term newborn infants, born vaginally, whose mothers had received intravenous pethidine within 3 hours of delivery | |
Interventions | 1. Intramuscular naloxone at 30 minutes of life (0.01 mg/kg): n = 14 2. Placebo: n = 10 |
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Outcomes | Respiratory rate, tidal volume, minute ventilation, end‐tidal carbon dioxide tension, and the ventilatory response to inhalation of 4% carbon dioxide | |
Notes | NICU, North America, mid 1970s | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "By random number ... infants were selected", no further details reported |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Placebo‐controlled study but unclear if personnel were aware of infants' allocation to groups |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Near‐complete follow‐up but 2 infants in each group were excluded post‐randomisation because "lung compliance values changed more than 25% between the two determinations" |
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 |