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. 2018 Oct 12;2018(10):CD003483. doi: 10.1002/14651858.CD003483.pub3

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
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.