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

NCT02305160 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 327

Last updated 2014-12-02

No results posted yet for this study

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.

Conditions

  • Respiratory Distress Syndrome

Interventions

DRUG

Control

The pulmonary surfactants commercially available in Brazil Survanta or Curosurf: 100 mg/kg, IT, maximum of 3 doses.

DRUG

Butantan

Use of Butantan surfactant 100 mg/kg, IT, maximum of 3 doses

Sponsors & Collaborators

  • Ministry of Health, Brazil

    collaborator OTHER_GOV

  • University of Sao Paulo

    lead OTHER

Principal Investigators

  • Alexander R Precioso, MD PhD · University of Sao Paulo Medical School Department of Pediatrics

  • Celso M Rebello, MD PhD · University of Sao Paulo Medical School - Department of Pediatrics

  • Renata S Mascaretti, MD PhD · University of Sao Paulo Medical School Department of Pediatrics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Minute
Max Age
24 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-04-30
Primary Completion
2006-05-31
Completion
2007-07-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02305160 on ClinicalTrials.gov