Am J Perinatol. 2004 Apr;21(3):109-19.
Ramanathan R, Rasmussen MR, Gerstmann DR, Finer N, Sekar K.
Department of Pediatrics, Division of Neonatal Medicine, Women’s and Children’s Hospital and Good Samaritan Hospital, Keck School of Medicine, University of Southern California, Los Angeles, California. [email protected]
We compared the onset of clinical response and safety of two surfactants, poractant alfa (Curosurf, Chiesi Pharmaceuticals, Parma, Italy) and beractant (Survanta, Ross Laboratories, Columbus, OH), for treatment of respiratory distress syndrome (RDS) in preterm infants weighing 750 to 1750 g at birth and <35 weeks gestation.
The study was performed as a 20-center prospective, randomized, masked comparison trial. Preterm infants (n = 293) with RDS were randomized to receive an initial dose of either 100 (n = 96) or 200 (n = 99) mg/kg of poractant alfa or 100 ( n = 98) mg/kg of beractant.
All repeat dosing was given at 100 mg/kg. The onset of clinical response after the first dose was studied by comparing changes in the fraction of inspired oxygen (F IO(2)) between 0 and 6 hours measured using the area under the curve (F IO(2) AUC (0-6)); other outcomes were assessed for the entire cohort at 28 days and for infants born at </= born span RDS.
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