A Multicenter, Randomized, Open Label Trial of a New Animal Extracted Surfactant to Treat RDS in Preterm Infants

University of Sao Paulo

Status and phase

Completed

Phase 3

Phase 2

Conditions

Respiratory Distress Syndrome

Treatments

Drug: Butantan

Drug: Control

Study type

Interventional

Funder types

Other

Identifiers

NCT02305160

012005B

Details and patient eligibility

About

The purpose of this study is to determine the efficacy and safety of the new pulmonary surfactant produced by Butantan Institute among premature infants with gestational age below 34 weeks with RDS, comparing to the pulmonary surfactants commercially available in Brazil.

Full description

Exogenous surfactant replacement therapy has been one of the major advances in the treatment of premature infants with respiratory distress syndrome (RDS). It has decreased the mortality among premature infants with RDS, determining changes in the children mortality rates among the developed countries. High cost, however, has been a major handicap for its wide use in developing and underdeveloped countries. Based on that, Butantan Institute (Sao Paulo, Brazil) has developed a new porcine pulmonary surfactant preparation at lower production cost. Initial animal studies showed similar improvement in lung mechanics and histopathologic findings to those observed with commercially available preparations.

Comparison(s): The new surfactant developed and produced by Butantan Institute will be compared to the commercially available pulmonary surfactants in Brazil, regarding to the efficiency to maintain a good arterial oxygenation, low airway pressures after treatment, similar mortality rates, and similar rates of complications like bronchopulmonary dysplasia and pulmonary hemorrhage.

Enrollment

327 patients

Sex

All

Ages

1 minute to 24 hours old

Volunteers

No Healthy Volunteers

Inclusion criteria

Gestational age below 34 weeks
RDS diagnosis based on clinical and RDS radiographic patterns
Need of mechanical ventilation
Parental consent

Exclusion criteria

Age greater than 24 hours
Major congenital malformations
Unstable hemodynamic status
Occurence of seizure during the stay in the Neonatal Intensive Care Unit
Maternal and/or fetal infection (chorioamnionitis: maternal fever, foul vaginal discharge, fetal tachycardia, uterine tenderness, leukocytosis or leukopenia) or congenital infection