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

• Status: Completed
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Sao Paulo
• Collaborator: Ministry of Health, Brazil
• Treatments: Beractant; Poractant alfa; Pulmonary Surfactants

Criteria

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