Table 1

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