title: Improved neonatal survival following multiple doses of bovine surfactant in very premature neonates at risk for respiratory distress syndrome.
abstract: To determine whether multiple doses of bovine surfactant would improve neonatal mortality in very premature neonates, we conducted two multicenter controlled trials under identical protocols; the results were combined for analysis. Four hundred and thirty neonates born between 23 and 29 weeks gestation and weighing 600 to 1250 g at birth were assigned randomly at birth to receive either 100 mg of phospholipids/kg of Survanta, a modified bovine surfactant (n = 210), or a sham air placebo (n = 220) within 15 minutes of birth. Neonates who developed respiratory distress syndrome and required mechanical ventilation with at least 30% oxygen could be given up to three more doses in the first 48 hours after birth. Dosing was performed by investigators not involved in the clinical care of the neonates; nursery staff were kept blinded as to the treatment assignment. Cause of death was determined by a panel of three independent, board-certified neonatologists after blindly reviewing case report forms and autopsy reports. Fewer Survanta-treated neonates died of any cause (11.4% vs 18.8%, P = .031), died of respiratory distress syndrome (1.9% vs 15.6%, P less than .001), and either died or developed bronchopulmonary dysplasia due to respiratory distress syndrome (39.5% vs 49.1%, P = .044). The incidence of respiratory distress syndrome was also lower in Survanta-treated neonates (28.0% vs 56.9%, P less than .001), and the Survanta-treated neonates' oxygenation and ventilatory status were improved significantly at 72 hours. Survanta-treated neonates were also at lowered risk of developing pulmonary interstitial emphysema (23.3% vs 36.9%, P = .002) and other forms of pulmonary air leaks (9.6% vs 20.8%, P .002).(ABSTRACT TRUNCATED AT 250 WORDS)
authors.affiliation: Minneapolis Childrens Medical Center, Seattle, Washington.
authors.forename: R E
authors.initials: RE
authors.lastname: Hoekstra
authors.forename: J C
authors.initials: JC
authors.lastname: Jackson
authors.forename: T F
authors.initials: TF
authors.lastname: Myers
authors.forename: I D
authors.initials: ID
authors.lastname: Frantz
authors.forename: M E
authors.initials: ME
authors.lastname: Stern
authors.forename: W F
authors.initials: WF
authors.lastname: Powers
authors.forename: M
authors.initials: M
authors.lastname: Maurer
authors.forename: J R
authors.initials: JR
authors.lastname: Raye
authors.forename: S T
authors.initials: ST
authors.lastname: Carrier
authors.forename: J H
authors.initials: JH
authors.lastname: Gunkel
mesh_terms: D000280:Administration, Inhalation; D000818:Animals; D001724:Birth Weight; D001997:Bronchopulmonary Dysplasia / Q000453:epidemiology / Q000401:mortality; D002417:Cattle; D002423:Cause of Death; D006801:Humans; D007231:Infant, Newborn; D007234:Infant, Premature; D015993:Life Tables; D011663:Pulmonary Surfactants / Q000008:administration & dosage*; D012121:Respiration, Artificial; D012127:Respiratory Distress Syndrome, Newborn / Q000453:epidemiology / Q000401:mortality* / Q000517:prevention & control; D012307:Risk Factors; D013997:Time Factors
chemical_list: D011663:Pulmonary Surfactants