Studies: | Randomised or quasi-randomised controlled trials |
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Participants: | Newborn infants, cared for in a hospital setting, with suspected or confirmed exposure to maternal narcotic analgesia before delivery |
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Interventions: | Naloxone versus placebo or no drug |
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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 |
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| 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 |
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Subgroup analyses: | 1. Dose of naloxone <0.1 mg/kg body weight |
| 2. Dose of naloxone ≥0.1 mg/kg |