Early treatment of respiratory distress syndrome with bovine surfactant in very preterm infants: a multicenter controlled clinical trial.
OBJECTIVE
To determine the effect of bovine surfactant (SF-RI 1, Alveofact) administered during the first hour following birth to very premature infants [gestational age (GA), 25-30 weeks] in a multicenter, controlled trial.


OBJECTIVE
Survival without bronchopulmonary dysplasia (BPD; definition: ventilator dependency or FiO2 greater than 0.3 during spontaneous respiration) at day 28 is increased in surfactant-treated infants (sequential analysis).


METHODS
Thirty-four infants [GA 28.0 +/- 1.5 SD weeks, birth weight (BW), 1,048 +/- 299 g] received 50 mg/kg BW surfactant, whereas 35 infants (GA, 27.6 +/- 1.5 weeks, BW 969 +/- 269 g) served as controls. Retreatment with surfactant (up to three identical doses) 12-24 hours after the previous dose was permitted if FiO2 was greater than 0.5.


RESULTS
Survival without BPD was significantly higher in surfactant treated infants (26/34) compared to controls (14/35; P = 0.003), but in the incidence of pulmonary air leaks, patent ductus arteriosus, intracranial hemorrhage, and nosocomial infections they were not different.


CONCLUSIONS
Bovine surfactant treatment improves survival without BPD in very premature infants at risk for neonatal respiratory distress syndrome (RDS).
Gortner
L
L
University Children's Hospital Ulm, Federal Republic of Germany.
Bartmann
P
P
Pohlandt
F
F
Bernsau
U
U
Porz
F
F
Hellwege
H H
HH
Seitz
R C
RC
Hieronimi
G
G
Bremer
C
C
Jorch
G
G
D001419:Bacteria / Q000302:isolation & purification; D001997:Bronchopulmonary Dysplasia / Q000150:complications; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D007234:Infant, Premature; D008055:Lipids / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D010100:Oxygen / Q000097:blood; D010743:Phospholipids; D010865:Pilot Projects; D011663:Pulmonary Surfactants / Q000008:administration & dosage / Q000627:therapeutic use*; D012121:Respiration, Artificial; D012127:Respiratory Distress Syndrome, Newborn / Q000097:blood / Q000188:drug therapy* / Q000401:mortality / Q000628:therapy; D015996:Survival Rate; D013997:Time Factors
D008055:Lipids; D010743:Phospholipids; D011663:Pulmonary Surfactants; C078272:SF-RI 1, bovine surfactant preparation; D010100:Oxygen