A Comparison of Efficacy Between Two Natural Exogenous Surfactant Preparations in Premature Infants with Respiratory Distress Syndrome

Abstract

The mortality and various morbidity rates have been substantially reduced by means of exogenous surfactant replacement, the cornerstone in the treatment of respiratory distress syndrome (RDS) in premature infants.
The objective of this study is to compare two natural surfactant preparations (Alveofact®, Survanta®) in terms of effectiveness and side-effects.
A total of 50 infants with RDS were given surfactant due to RDS were taken into the scope of this study. Survanta® and Alveofact® were administered to randomized infants with RDS and the results obtained during clinical observations were compared.
Second hour mean FiO₂, MAP and a/APO₂ values showed changes in favour of Alveofact® (n = 25) group compared to the Survanta® (n = 25) group (p < 0.05 for each parameter). However, this difference disappeared in the 6^th hour. No statistical difference was established between the two groups with regard to sideeffects (pneumothorax, sepsis, intraventricular hemorrhage, bronchopulmonary dysplasia), duration of mechanical ventilation in survivors, duration of hospitalization in survivors and mortality before the 28^th day.
It was concluded that results obtained with different surfactant preparations having dissimilar compositions were not different in terms of final impacts and side-effects.

Zusammenfassung

Die Mortalität und Morbidität Frühgeborener konnte durch den Einsatz von exogenem Surfactant in der Therapie des Atemnotsyndroms Frühgeborener (RDS) bedeutsam gesenkt werden.
Das Ziel der vorliegenden Studie war es, zwei natürliche Surfactantpräparationen (Alveofact® und Survanta®) hinsichtlich der Wirkung und möglicher Nebenwirkungen zu vergleichen.
Insgesamt 50 Frühgeborene mit RDS wurden mit Surfactant behandelt. Alveofact® oder Survanta® wurden nach Randomisierung Frühgeborenen mit RDS intratracheal gegeben und die klinischen Behandlungsresultate verglichen.
Die 2-Stunden-Werte nach Applikation für FiO₂, mittleren Atemwegsdruck (MAP) und die alveoloarterielle Ratio des Sauerstoffpartialdrucks zeigten einen verbesserten Effekt von Alveofact® (n = 25) im Vergleich zur Survanta®-behandelten Gruppe (n = 25) an (p < 0,05 für jede Variable).
Dieser Unterschied war jedoch jenseits der 6. Stunde nicht mehr nachweisbar.
Keine statistische signifikanten Unterschiede wurden zwischen beiden Gruppen hinsichtlich der Nebenwirkungen bzw. begleitender Morbidität gefunden (Pneumothorax, Sepsis, intraventrikulärer Hämorrhagie, bronchopulmonale Dysplasie), Zeitdauer der mechanischen Beatmung, Zeitdauer des Hospitalisierung und Mortalität bis zum 28. Lebenstag.
Es wird geschlussfolgert, dass die Behandlungsresultate mit verschiedenen natürlichen Surfactantpräparationen hinsichtlich der mittelfristigen Zielvariablen sowie der Nebenwirkungen nicht different waren.

Key words

Alveofact® - natural surfactant - premature - respiratory distress syndrome - Survanta®

Schlüsselwörter

Alveofact® - Natural surfactanten - Frühgeborenen - Atemnotsyndrom - Survanta®

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