Prosurf® Estudios Clínicos Protocolizados 2018-01-10T04:59:39+00:00

Estudios Clínicos Protocolizados.

Surfactante pulmonar exógeno en el tratamiento de la
 enfermedad de membrana hialina severa: efectos agudos.
Dres. Claudio Solana, Cristina Osio, Susana Luján, Carmen Vecchiarelli, A. Miguel Larguía, Osvaldo Stoliar y Luis Prudent.

 Summary

The purpose of this study was to determine the acute effects of a rescue therapy with a natural exogenous surfactant produced in Argentina. Forty premature infants (Pret) with severe hyaline membrane disease (HMD) and requiring mechanical ventilation were treated by tracheal instillation with 90 mg/kg of surfactant in the first 24 hours of life, receiving up to three additional doses in the following two days based on ventilator requirements.

The group had a birth weight of x=1.268 g (r=630-2.470) with a gestational age of x=29.1 weeks (r=23-36). The first dose was administrated at x=4.7 Hours (r=0.5-24). Pre-treatment FiO2 was x=0.81 (SD=0.2), PaO2 x=59 mmHg (SD=15) and mean airway pressure (MAP) x=9.2 cmH2O (SD=3.8). Ten minutes later the PaO2 reached x=145 mmHg (SD=51, p<0.001). One hour later the FiO2 was x=0.54 (SD=0.28) (p<0.001) and these differences were maintained during the first 72 hours. The MAP decreased significantly only after 12 hours (MAP x=7.4 cm H2O, SD=3.2 with a p<0.02). This group received a mean of 2.1 doses. Sixteen Pret (40%) required only one dose, 16 (40%) received a second one (age=8.7 hours, r=2.5-24) and the remaining 8 (20%) three or four doses in the first 28 hours.

From 17 Pret with birth weight 1.000 g. Seven patients (17.5%) had some form of pulmonary air leak (4 neumothoraces and 4 interstitial emphysemas). Three Pret, all with birth weight

We conclude that the treatment with this surfactant has acute effects improving HMD outcome. We could not find any adverse effect related with surfactant administration.

 Key words: exogenous surfactant, hyaline membrane disease, premature infants, neonatology, pulmonology.

Arch. Arg. Pediatr. 1993;91:65

Estudio clínico de un Nuevo surfactante natural de extracción bovina en el tratamiento del síndrome de dificultad respiratoria neonatal.
Dres. Eduardo Halac, Cristina Ottino, José M. Paisani y Lic. Klg. Ricardo J. Obregón.

Summary

Introduction . Exogenous surfactants are considered an important part in the treatment of neonatal respiratory distress syndrome.

Objectives. To evaluate the efficacy, effectiveness and efficiency of a new natural surfactant extracted by alveolar lavage from young bovine lungs.

Population. Appropriate for gestational age preterm newborns admitted to an intensive care neonatal unit, diagnosed as having respiratory distress syndrome, type I and requiring mechanical ventilation.

Methods. Random surfactant samples from ready-to-use vials were analyzed for surface active properties and chemical composition and compared with data provided by the manufacturer of the new product.

Selected patients were randomized to receive either of two known products: Survanta and Natsurf. In the experimental arm, the new surfactant Baby-Fact was used. All infants received three doses of surfactants, 8 hours apart.

Main outcome measures. Changes in arterial blood gases, oxigenation indexes, mean airway pressures, oxygen a/A ratios, specific and general (before discharge) mortality, incidence of chronic lung disease, and adverse effects during instillation. Incidence rates for apnea, air-leak syndromes, necrotizing enterocolitis, retinopathy of prematurity, patent ductus arteriosus, intraventricular hemorrhage and leukomalacia were determined.

Results. Surface active capacity and chemical composition of the new product were not significantly different from those reported by the manufacturer. Neither significant differences nor valid associations were found for the different outcome measures for any of the surfactants studied. Both survival and chronic lung disease rates were similar in all groups. Cost-benefit ratios indicate a better performance for the new product, compared to the other two, despite similar profiles of clinical effectiveness.

Archivo Argentino  Pediatría. 2002; 100 (2): 120 – 129