| Methods |
Randomised controlled trial |
| Participants |
43 term newborn infants whose mothers had received routine narcotic analgesia within 6 hours of delivery. Infants delivered in breech presentation or by Caesarean section, and infants with Apgar score less than 6 at 1 minute, were excluded |
| Interventions |
1. Intramuscular naloxone (0.02 mg/kg body weight): n = 22
2. Placebo (normal saline): n = 21 |
| Outcomes |
Apgar score at 5 minutes, capillary blood gas values at 1, 2 and 4 hours of life, neurobehavioural assessment at 1, 4, and 24 hours |
| Notes |
NICU, North America, late 1970s |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Random sequence generated in pharmacy to produce sequentially numbered ampoules containing either naloxone or placebo |
| Allocation concealment (selection bias) |
Low risk |
Sequentially numbered ampoules (unable to predict whether naloxone or placebo) |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Placebo‐controlled study using sequentially numbered ampoules ‐ personnel unlikely to have been aware of infants' group allocation |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
"The testers were not aware of which infants received naloxone or placebo" |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Complete ascertainment of outcomes |
| 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 |
