title: Early versus late surfactant treatment in preterm infants of 27 to 32 weeks' gestational age: a multicenter controlled clinical trial.
abstract: OBJECTIVE
  To investigate whether early (<1 hour after birth) surfactant administration would be superior to late treatment (2-6 hours after birth) in preterm infants.
  
  
  METHODS
  Randomized controlled multicenter clinical trial.
  
  
  METHODS
  Prenatal randomization of all infants of 27 to 32 weeks' gestational age stratified by center after parental informed consent. Early treatment: 100 mg/kg body weight bovine surfactant (SF-RI1, Alveofact; Dr K. Thomae, Biberach, Germany) to infants requiring intubation after birth. Late treatment: identical dosage to infants requiring intubation up to 6 hours of age with the fraction of inspired oxygen >0.4 at 2 to 6 hours after birth. Primary endpoint: the time on mechanical ventilation. Main secondary endpoints: mortality, bronchopulmonary dysplasia, intraventricular hemorrhage >/=grade III, and periventricular leukomalacia. Sample size calculation: at least 280 infants to prove superiority of either approach (alpha = 0.05; beta = 0.90).
  
  
  RESULTS
  Enrollment of 317 infants, 154 randomized to early surfactant treatment, 163 to late surfactant treatment. Study infants (all following data intent-to-treat groups: early versus late surfactant) were similar with respect to: gestational age, 29.5 +/- 1.6 weeks versus 29.7 +/- 1.6 weeks; birth weight, 1227 +/- 367 g versus 1269 +/- 334 g; and the rate of prenatal corticosteroids, 79.9% versus 72.8%. Duration of mechanical ventilation: 3 days (0-8) versus 2 days (0-6) (median, interquartile); further outcome variables: death or bronchopulmonary dysplasia (day 28) 25.9% versus 23.9%, mortality 3.2% versus 1.8%, intraventricular hemorrhage >/=grade III 6.5% versus 3.7%, and periventricular leukomalacia 5.2% versus 5.5% not differing statistically.
  
  
  CONCLUSIONS
  In preterm infants with a high rate of prenatal glucocorticoids, early surfactant administration was not found to be superior to late treatment in terms of relevant outcome variables.
authors.affiliation: University Children's Hospital, Lübeck, Germany.
authors.forename: L
authors.initials: L
authors.lastname: Gortner
authors.forename: R R
authors.initials: RR
authors.lastname: Wauer
authors.forename: H
authors.initials: H
authors.lastname: Hammer
authors.forename: G J
authors.initials: GJ
authors.lastname: Stock
authors.forename: F
authors.initials: F
authors.lastname: Heitmann
authors.forename: H L
authors.initials: HL
authors.lastname: Reiter
authors.forename: P G
authors.initials: PG
authors.lastname: Kühl
authors.forename: J C
authors.initials: JC
authors.lastname: Möller
authors.forename: H J
authors.initials: HJ
authors.lastname: Friedrich
authors.forename: I
authors.initials: I
authors.lastname: Reiss
authors.forename: R
authors.initials: R
authors.lastname: Hentschel
authors.forename: G
authors.initials: G
authors.lastname: Jorch
authors.forename: G
authors.initials: G
authors.lastname: Hieronimi
authors.forename: E
authors.initials: E
authors.lastname: Kuhls
mesh_terms: D004334:Drug Administration Schedule; D005865:Gestational Age; D006801:Humans; D007231:Infant, Newborn; D007234:Infant, Premature; D008055:Lipids / Q000008:administration & dosage*; D010743:Phospholipids; D011295:Prenatal Care; D011659:Pulmonary Gas Exchange; D011663:Pulmonary Surfactants / Q000008:administration & dosage*; D012121:Respiration, Artificial; D012127:Respiratory Distress Syndrome, Newborn / Q000188:drug therapy* / Q000401:mortality / Q000628:therapy; D013997:Time Factors
chemical_list: D008055:Lipids; D010743:Phospholipids; D011663:Pulmonary Surfactants; C078272:SF-RI 1, bovine surfactant preparation