摘要Background Neonatal respiratory distress syndrome (NRDS) is caused by a deficiency in pulmonary surfactant (PS) and is one of the main reasons of neonatal mortality. This study was conducted to evaluate the efficacy and safety of intra-amniotic administration of pulmonary surfactant for prophylaxis of NRDS.Methods Forty-five pregnant women who were due for preterm delivery and whose fetuses' lungs proved immature were divided into two groups. Fifteen women (study group) were administered one dose of pulmonary surfactant injected into the amniotic cavity and delivered within several hours. Nothing was injected into the amniotic cavity of 30 women of the control group. The proportion of neonatal asphyxia, NRDS, mortality and the time in hospital were analyzed to determine if there was any difference between the two groups. Results There was no significant difference between the two groups for neonatal asphyxia. Foam tests showed that higher proportion of neonates in the study group than in the control group (56.3% vs 13.3%, P<0.05) had lung maturity. A greater number of control neonates (11/30, 32.3%) had NRDS, compared with the neonates given PS via the amniotic cavity before delivery (1/16, 6.3%, P<0.05). The neonates in the study group spent nearly 10 days less in hospital than the control group [(32.4±7.6) days vs (42.0±15.7) days, P<0.05], but the difference in mortality between the two groups was not statistically significant. Conclusions Intra-amniotic administration of pulmonary surfactant can significantly reduce the proportion of NRDS and the time in hospital of preterm neonates. Whether this method can reduce the mortality of preterm neonates needs to be evaluated further. Intra-amniotic administration of pulmonary surfactant provides an additional effectual means for NRDS prophylaxis.