Status:
COMPLETED
A Multicenter, Randomized, Open Label Trial of a New Animal Extracted Surfactant to Treat RDS in Preterm Infants
Lead Sponsor:
University of Sao Paulo
Collaborating Sponsors:
Ministry of Health, Brazil
Conditions:
Respiratory Distress Syndrome
Eligibility:
All Genders
1-24 years
Phase:
PHASE2
PHASE3
Brief 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, c...
Detailed 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 prematu...
Eligibility Criteria
Inclusion
- Gestational age below 34 weeks
- RDS diagnosis based on clinical and RDS radiographic patterns
- Need of mechanical ventilation
- Parental consent
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
327 Patients enrolled
Trial Details
Trial ID
NCT02305160
Start Date
April 1 2005
End Date
July 1 2007
Last Update
December 2 2014
Active Locations (30)
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1
Hospital Esau de Matos
Vitória da Conquista, Estado de Bahia, Brazil, 45065-540
2
Hospital Regional de Taguatinga
Brasília, Federal District, Brazil, 70673-423
3
Hospital Materno Infantil
Goiânia, Goiás, Brazil, 74673-200
4
Hospital Universitario - Unidade Materno Infantil
São Luís, Maranhão, Brazil, 65020-460