A European multicenter randomized controlled trial of single dose surfactant therapy for idiopathic respiratory distress syndrome.
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)
Horbar
J D
JD
Department of Pediatrics, University of Vermont College of Medicine, Burlington 05405.
Soll
R F
RF
Schachinger
H
H
Kewitz
G
G
Versmold
H T
HT
Lindner
W
W
Duc
G
G
Mieth
D
D
Linderkamp
O
O
Zilow
E P
EP
D000280:Administration, Inhalation; D000704:Analysis of Variance; D001997:Bronchopulmonary Dysplasia / Q000139:chemically induced; D002543:Cerebral Hemorrhage / Q000139:chemically induced; D004761:Enterocolitis, Pseudomembranous / Q000139:chemically induced; D005060:Europe; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D008297:Male; D015337:Multicenter Studies as Topic; D011446:Prospective Studies; D011663:Pulmonary Surfactants / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D012127:Respiratory Distress Syndrome, Newborn / Q000188:drug therapy*
D011663:Pulmonary Surfactants