Specified criteria for inclusion of studies
Studies: | Randomised or quasi-randomised controlled trials |
Participants: | Newborn infants, cared for in a hospital setting, with suspected or confirmed exposure to maternal narcotic analgesia before delivery |
Interventions: | Naloxone versus placebo or no drug |
Outcomes: | Primary: |
1. Assisted ventilation in the neonatal period | |
2. Duration of assisted ventilation | |
3. Admission to neonatal unit or special care baby unit | |
4. Duration of neonatal unit or special care baby unit admission | |
Secondary: | |
1. Time to establish full oral feeds, independently of parenteral fluids or nutrition or of enteral tube feeding | |
2. Features of opiate withdrawal; validated behavioural assessment in the neonatal period | |
3. Seizures in the neonatal period | |
4. Neurodevelopmental outcomes during infancy and beyond using validated assessment tools | |
5. Measures of respiratory function, such as Apgar score, or arterial blood pH or arterial or alveolar carbon dioxide tension measured within the first six hours of life | |
Subgroup analyses: | 1. Dose of naloxone <0.1 mg/kg body weight |
2. Dose of naloxone ≥0.1 mg/kg |