title: Surfactant replacement therapy in neonatal respiratory distress syndrome. A multi-centre, randomized clinical trial: comparison of high- versus low-dose of surfactant TA.
abstract: We conducted a prospective, randomized, controlled trial comparing the efficacy of two doses of a reconstituted bovine surfactant (Surfactant TA) in premature infants requiring mechanical ventilation shortly after birth for respiratory distress syndrome. Forty-six infants weighting 1000-1499 g were randomized into two groups: a low-dose group (23 infants given a single dose of 60 mg surfactant lipid/kg) and a high-dose group (23 infants given a single dose of 120 mg/kg). The mean (SD) age at which surfactant was given was 5.5 (+/- 1.2) h in the low-dose group and 6.0 (+/- 1.5) h in the high dose group. Both treatments improved oxygenation (increased arterial-alveolar PO2 ratio) with decreased mean airway pressure, the high-dose surfactant having a more beneficial effect in prolonging the response. Infants in the high-dose group had significantly less (P less than 0.05) incidence of both intraventricular haemorrhage and bronchopulmonary dysplasia. This prospective trial documents that a greater benefit can be obtained by increasing the dose of surfactant (120 mg/kg) beyond 60 mg/kg treatment of premature infants with severe respiratory distress syndrome (RDS).
authors.affiliation: Department of Pediatrics, Iwate Medical University, Japan.
authors.forename: M
authors.initials: M
authors.lastname: Konishi
authors.forename: T
authors.initials: T
authors.lastname: Fujiwara
authors.forename: T
authors.initials: T
authors.lastname: Naito
authors.forename: Y
authors.initials: Y
authors.lastname: Takeuchi
authors.forename: Y
authors.initials: Y
authors.lastname: Ogawa
authors.forename: K
authors.initials: K
authors.lastname: Inukai
authors.forename: M
authors.initials: M
authors.lastname: Fujimura
authors.forename: H
authors.initials: H
authors.lastname: Nakamura
authors.forename: T
authors.initials: T
authors.lastname: Hashimoto
mesh_terms: D002986:Clinical Trials as Topic; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D007234:Infant, Premature; D008297:Male; D011663:Pulmonary Surfactants / Q000008:administration & dosage / Q000627:therapeutic use*; D011897:Random Allocation; D012127:Respiratory Distress Syndrome, Newborn / Q000188:drug therapy*
chemical_list: D011663:Pulmonary Surfactants