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We performed a randomized clinical trial comparing intratracheal administration of surfactant with assisted ventilatiory treatment with mechanical ventilation alone for treatment of neonatal respiratory distress syndrome. Twenty two premature infants with respiratory distress syndrome were randomly assigned to surfactant-treated or control group. Thirteen infants (mean gestational age: 29.3±1.8weeks, mean birth weight: l,424±227.3gm) were given surfactant-TA. and nine infants received intermittent mandatory ventilation only. The results were as follows: 1) We investigated the severity of respiratory distress syndrome by grading .which were severe, intermediate and minimal, at each point. Intermediate and severe categories were more rapidly changed to minimal in the surfactant-treated group than the control. Especially, those were improved at the 24 hours after surfactant administration significantly(46.2 vs 0%) (p<0.05). 2) Within 6 to 96hours of replacement of surfactant, there were significantly improved oxygenation with decreased FiO2 and increased a/APO2 and diminished the need for respiratory support with decreased Ⅵ index and mean airway pressure in the surfactant-treated group than the control(p<0.05∼0.005). 3) A decrease in the need for respiratory support was also reflected by a shortening of the total duration in assisted ventilation(6.7 vs 11.5days), supplemental oxygen(17.5 vs 32.25days)and high supplemental oxygen over 40%(3.0 vs 4.7days) in the surfactant-treated group. 4) In the surfactant-treated group, sepsis, IVH, PDA and NEC occured more often, and pneumothorax, pulmonary interstitial emphysema, bronchopulmonary dysplasia and apnea occured less. But, the difference of these complications were not significant. 5) Infants in the surfactant-treated group had decreased mortality, but it was not significant. And, the major causes of death were pulmonary hemorrhage and sepsis in both groups, but there was no significant difference between two groups. We concluded that replacement of surfactant is effective therapy that can improve the pulmonary function with diminution the need for oxygen and respiratory support.
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