Clinical trials of human lung surfactant from amniotic fluids in neonatal respiratory distress syndrome

Аннотация

Objective: Estimation of the efficiency, tolerance and safety of «Surfactant-HL» (ST-HL) (CRIRR, St. Petersburg, Russia) for treatment of neonatal respiratory distress syndrome (NRDS) was performed in 5 Russian neonatal departments in Moscow and St. Petersburg.

Полный текст

Methods: 145 ventilated preterm infants (gestational weeks 31.6 + 0.43, birth weight 1696 +65,8 g suffering from RDS were observed: 86 of them were treated with ST-HL (50 mg/kg, one of two administrations), the rest 59 infants formed a control group (K).

Results: improvement of lung functions was registered in 67%-82% of patients in different hospitals after ST-HL treatment. ST-HL reduced period necessary to achieve Fi02=0.4 from 126.8 h (K) down to 80.6 h (P<0,05) and CMV period from 229.8 h (K) down to 165.8 h (P<0,05). Intolerance to the formulation was not observed. Safety of ST-HL was estimated in accordance with the rate of direct complications caused by ST-HL administration (airway obstruction 4,6% and pulmonary hemorrhage 1.2%), as well as the rate of perinatal period complications whose frequency can vary during ST-HL treatment. The following complications were found: pneumothorax and pulmonary interstitial emphysema 10.1%, broncho-pulmonary dysplasia 7.0%, periventricular haemorrhage 14%, intraventricular haemorrhage HI-IV 7%, ductus arteriosus persistens 24.4%, sepsis 6.2%, secondary pneumonia 19.8%. These data were similar to the data obtained with oilier natural surfactants [Wauer RR et al., Klin Padiatr 1996, 208:355-65]. The 7th-day mortality was 8.3%, and 28th-day mortality was 15.1%. NRDS caused death only in 2.3% of patients.

Conclusion: ST-HL can be used for NRDS treatment in neonatal intensive care units of II-III levels.