Comparative trial of artificial and natural surfactants in the treatment of respiratory distress syndrome of prematurity: experiences in a developing country

Abstract

We conducted a randomized clinical trial to compare the effects of a synthetic (Exosurf) and natural (Survanta) surfactant in infants with neonatal respiratory distress syndrome. Eighty-nine patients were randomly allocated to receive one of the two surfactants. Primary outcome variables were the acute and long-term effects of the surfactant preparations, i.e., ventilatory requirements at 24 h of age as judged by the oxygenation index (OI), and the combined incidence of chronic lung disease or death at 28 days. The OIs in the Exosurf and Survanta groups at 24 h were the same (10.1 and 7, respectively; P > 0.05). The magnitude and rapidity of response, however, were greater for Survanta than for Exosurf. When arterial/alveolar oxygen tension ratios (a/A) were compared, the Exosurf group had a significantly worse a/A ratio at 24 h than the Survanta group (0.21 Exosurf vs. 0.37 Survanta; P < 0.05). The long-term outcome as judged by the combined incidence of death or chronic lung disease was not different in the two groups (18.6% Exosurf vs. 15.2% Survanta; P > 0.05). When the complications of prematurity were compared, there were no statistically significant differences between the two groups. We conclude that both preparations are reasonable choices for the treatment of respiratory distress syndrome of prematurity.

PIP: This study compares the effects of synthetic (Exosurf) and natural (Survanta) surfactants on infants with neonatal respiratory distress syndrome in Oman. Subjects included 89 patients, randomly allocated to receive one of the two surfactants. Results suggest that 43 and 46 of the total infants enrolled in the study were randomized to the Exosurf and Survanta groups, respectively. The oxygenation index in the Exosurf and Survanta groups at 24 hours were the same (10.1 and 7, respectively; P 0.05). The magnitude and rapidity of response, however, were greater for Survanta than for Exosurf. Moreover, when arterial/alveolar oxygen tension ratios (a/A) were compared, the Exosurf group had a significantly worse a/A ratio at 24 hours than the Survanta group. There were no statistically significant differences between the two groups when the complications of prematurity were compared. In conclusion, both preparations offer reasonable choices in the treatment of the respiratory distress syndrome. However, this should be weighed against the minor theoretical risks of transmission of infectious agents in a natural preparation, and the easier storage and transport of the synthetic surfactant.