A clinical trial of comparison between surfactant-TA Exosurf neonatal for the treatment of ldiopathic Respiratory Distress Syndrome were carried out.
We conducted prospective trial of comparing the efficacy of surfactant TA and Exosurf neonatal in 14 premature infants (birth weight of 700!2500gm, gestational age of 28~35wks) with ldiopathic Respiratory Distress Syndrome from June, 1994 to
April,
1995.
Fourteen infants were randomized into two groups: surfactant-TA treated Group l and Exosurf neonatal treated Group ll.
@ES The summary of the study is as follows:
@EN 1) There were no significant differences between group I and II in sex, birth weight, gestational age, Apgar score and the duration of surfactant treatment(p>0.05).
2) There was no significant differences between two group in terms of FiO2 requirment and a/A PO2(p>0.05).
3) MAP was slightly low in the Group ll until the 48 hours of the surfactant supplementation but no difference at the 120 hours after surfactant treatment.
4) The total duration of the assisted ventilation was 2.9 days in Group l and 3.1 days in Group ll.
5) There was no differences in survival rate( in Group I 68%, Group II 67%). But in regard to complications, the incidence of necrotizing enterocolitis, sepsis were slightly high in Group l, and of patent ductus arteriosus, retinopathy of
prematurity
were high in Group ll. Since the patient numbers were relatively small for definitive conclusion with two group study, we presume that more clinical trials are required.
|