Characteristics of included studies: participants, intervention, and outcomes
Trial | Participants | Interventions | Outcomes | Notes |
---|---|---|---|---|
Bonta8 | 43 normal term newborn infants whose mothers received narcotic analgesia within six hours of delivery. | 1. Intramuscular naloxone (0.02 mg/kg) (n=22) | Apgar score at five minutes, capillary blood gas values at 1, 2, and 4 hours of life, neurobehavioral assessment at 1, 4, and 24 hours. | Infants delivered in breech presentation or by caesarean section, infants with Apgar score <6 at one minute, were excluded. |
2. Placebo (saline) (n=21) | ||||
Brice9 | 50 term newborn infants whose mothers received pethidine within four hours of delivery. | 1.Naloxone via umbilical vein (0.01 or 0.02 mg/kg) (n=26) | Time to sustained respiration, expired CO2 output and alveolar ventilation, Brazelton score and Scanlon score within the first 24 hours of life. | Blinding of outcome measurement for Scanlon score only. |
2. No drug (n=24) | ||||
Dick10 (a) | 40 newborn infants, of unspecified gestation, whose mothers had been given pethidine in labour. | 1. Naloxone via umbilical vein (0.02–0.04 mg/kg) (n=30) | Capillary blood gas pH and partial pressure of CO2 and of oxygen at 1, 5, 10, 30, 60, and 120 minutes of life. | Presumed, although not stated explicitly in the report, that naloxone was administered at birth. |
2. No drug (n=10) | ||||
Dick10 (b) | 30 newborn infants, of unspecified gestation, whose mothers had been given pethidine in labour. | 1. Naloxone via umbilical vein (either 0.04 mg/kg or 0.04 mg total) (n=10) | Capillary blood gas pH, partial pressure of CO2 and of oxygen, and calculated base excess at 1, 5, 10, 30, 60, and 120 minutes of life. | |
2. Placebo (n=20) | ||||
Evans11 | 44 newborn infants, of gestation 38–42 weeks, delivered vaginally, whose mothers had been given pethidine in labour. | 1.Naloxone via umbilical vein (0.04 mg total) (n=20) | Time to first breath and onset of sustained respiration, Apgar score at five minutes, alveolar CO2 tension, alveolar ventilation, and ventilation rate at 10 and 30 minutes of life. | Apgar score, time to first breath and to sustained respiration reported as mean values, but without standard deviations. |
2. No drug (n=24) | ||||
Gerhardt12 | 20 term newborn infants, whose mothers received pethidine within three hours before delivery. | 1. Intramuscular naloxone (0.01 mg/kg) (n=12) | Respiratory rate, tidal volume, minute ventilation, end-tidal CO2 tension, and response to inhalation of 4% CO2. | Only infants born vaginally were eligible for inclusion. |
2. Placebo (n=8) | Naloxone was given at 30 minutes of age. | |||
Welles13 | 27 newborn infants, of gestation 38–42 weeks, whose mothers received pethidine during labour. | 1. Intramuscular naloxone (0.1 mg total) (n=14) | Brazelton score at 12–24 hours of life and after a further 48 hours. Broussard neonatal perception inventory at about 72 hours. | Naloxone was given at one hour. Infants with Apgar scores <8 at one minute, or <9 at five minutes were not eligible for inclusion. |
2. Placebo (saline) (n=13) | ||||
Wiener14 | 28 newborn infants, of gestation 38–42 weeks, whose mothers had been given pethidine in labour. | 1.Naloxone via the umbilical vein (0.04 mg total) (n=10) | Alveolar CO2 tension, CO2 excretion, alveolar ventilation, feeding behaviour, and habituation to a sound specific stimulus up to 48 hours of life. | Naloxone or normal saline were “chosen blind at random”. |
2. Placebo (saline) (n=18) | ||||
Wiener15 | 30 newborn infants, of gestation 38–42 weeks, whose mothers had been given pethidine in labour. | 1. Intramuscular naloxone at one minute of age (0.2 mg total) (n=15) | Alveolar CO2 tension, CO2 excretion, alveolar ventilation, feeding behaviour, and habituation to a sound specific stimulus up to 48 hours. | |
2. Placebo (saline) (n=15) |