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A European multicenter randomized controlled trial of single dose surfactant therapy for idiopathic respiratory
J D Horbar1, R F Soll, H Schachinger
1Department of Pediatrics, University of Vermont College of Medicine, Burlington 05405.
Insights
Surfactant treatment improved oxygenation in infants with respiratory distress syndrome but was stopped early due to increased periventricular-intraventricular hemorrhage risk. Long-term clinical status showed no significant differences between groups.
Area of Science:
- Neonatology
- Pediatric Pulmonology
- Critical Care Medicine
Background:
- Idiopathic respiratory distress syndrome (IRDS) is a common cause of respiratory failure in preterm infants.
- Surfactant replacement therapy is a cornerstone in managing IRDS, aiming to improve lung compliance and gas exchange.
Purpose of the Study:
- To evaluate the efficacy and safety of Survanta (a surfactant preparation) in preterm infants with IRDS requiring assisted ventilation.
- To assess the impact of surfactant therapy on oxygenation, respiratory support needs, and the incidence of periventricular-intraventricular hemorrhage (PIH).
Main Methods:
- A multicenter prospective randomized controlled trial involving 106 infants (750-1750 g) with IRDS.
- Infants received either Survanta (100 mg phospholipid/kg) or air intratracheally within 8 hours of birth.
- The study was halted early by the FDA due to observed differences in PIH incidence.
Main Results:
- Surfactant-treated infants showed significantly greater improvements in arterial-alveolar oxygen ratio (a/A ratio) and greater reductions in FiO2 and mean airway pressure (MAP) compared to controls within 48 hours.
- Statistically significant differences were observed for a/A ratio (P < 0.0001), FiO2 (P < 0.0001), and MAP (P < 0.017).
- No significant differences in clinical status (need for respiratory support or death) were found on days 7 and 28 between the surfactant and control groups.
Conclusions:
- Survanta administration in infants with IRDS leads to rapid improvements in oxygenation and reduced ventilatory support requirements.
- Despite improved short-term gas exchange, the increased risk of periventricular-intraventricular hemorrhage necessitates careful consideration of surfactant therapy in this population.
- Long-term clinical outcomes at 7 and 28 days did not differ significantly between surfactant-treated and control infants.
Abstract:
We performed a multicenter prospective randomized controlled trial to determine the efficacy and safety of the surfactant preparation, Survanta (Abbott Laboratories, Chicago, USA), for 750-1750 g infants with idiopathic respiratory distress syndrome, (IRDS) receiving assisted ventilation with 40% or more oxygen. One hundred and six eligible infants from the eight participating centers were randomly assigned between March 1986 and June 1987 to receive either surfactant (100 mg phospholipid/kg, 4 ml/kg) or air (4 ml/kg) administered into the trachea within 8 h of birth (median time of treatment 6.2 h, range 3.2-9.1 h). The study was stopped before enrollment was completed at the request of the United States Food and Drug Administration when significant differences were observed in incidence of periventricular-intraventricular hemorrhage (PIH), between the surfactant treated and control infants. Surfactant treated infants had larger average increases in the arterial-alveolar oxygen ratio, (a/A ratio) (P less than 0.0001), and larger average decreases in FiO2 (P less than 0.0001) and mean airway pressure, (MAP) (P less than 0.017) than controls over the 48 h following treatment. The magnitude of the differences between the surfactant and control groups were 0.19 (SE = 0.03) for a/A ratio, -0.28 (SE = 0.04) for FiO2 and -1.7 cm H2O (SE = 0.70) for MAP. The clinical status on days 7 and 28 after treatment was classified using four predefined ordered categories: (1) no respiratory support; (2) supplemental O2 with or without continuous positive airway pressure (CPAP); (3) intermittent mandatory ventilation; and (4) death. There were no statistically significant differences in the status categories on days 7 or 28 between surfactant and control infants.(ABSTRACT TRUNCATED AT 250 WORDS)