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

November 26, 2014 updated by: Celso Moura Rebello, University of Sao Paulo

Phase 3 Multicenter, Randomized, Open Label Trial of a New Low Cost Animal Extracted Surfactant to Treat Respiratory Distress Syndrome in Preterm Infants

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Actual)

327

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • BA
      • Vitoria da Conquista, BA, Brazil, 45065-540
        • Hospital Esau de Matos
    • DF
      • Brasilia, DF, Brazil, 70673-423
        • Hospital Regional de Taguatinga
    • GO
      • Goiania, GO, Brazil, 74673-200
        • Hospital Materno Infantil
    • MA
      • Sao Luis, MA, Brazil, 65020-460
        • Hospital Universitario - Unidade Materno Infantil
    • MG
      • Belo Horizonte, MG, Brazil, 30110-130
        • Maternidade Odete Valadares
      • Belo Horizonte, MG, Brazil, 30140-080
        • Santa Casa de Misericórdia de BH
      • Belo Horizonte, MG, Brazil, 30180-112
        • Hospital de Clínicas de Minas Gerais
      • Belo Horizonte, MG, Brazil, 30260-020
        • Hospital Sofia feldman
      • Belo Horizonte, MG, Brazil, 30575-740
        • Hospital Municipal Odilon Behrens
      • Belo Horizonte, MG, Brazil, 30620-470
        • Hospital Julia Kubstchek
    • PE
      • Recife, PE, Brazil, 50070-550
        • IMIP
      • Recife, PE, Brazil, 50731-000
        • Hospital Barão de Lucena
      • Recife, PE, Brazil, 52030-010
        • CISAM - Universidade de Pernambuco
    • RJ
      • Rio de Janeiro, RJ, Brazil, 20720-292
        • Hospital Maternidade Carmela Dutra
      • Rio de Janeiro, RJ, Brazil, 21610-645
        • Hospital Maternidade Alexandre Fleming
      • Rio de Janeiro, RJ, Brazil, 22040-000
        • Hospital Geral de Bonsucesso
      • Rio de Janeiro, RJ, Brazil, 22250-020
        • Instituto Fernandes Figueira
      • Rio de janeiro, RJ, Brazil, 20010-010
        • Hospital Maternidade Oswaldo de Nazareth
    • RS
      • Cachoeirinha, RS, Brazil, 94950-585
        • Hospital Cachoeirinha
      • Porto Alegre, RS, Brazil, 91430-001
        • Hospital Fêmina
      • Porto Alegre, RS, Brazil
        • Grupo Hospital Criança Conceicao
      • Porto Alegre, RS, Brazil
        • Hospital Alvorada
    • SE
      • Aracaju, SE, Brazil, 49060-640
        • Hospital Santa Isabel
      • Aracaju, SE, Brazil, 49085-310
        • Maternidade Hildete Falcao Batista
    • SP
      • Sao Paulo, SP, Brazil, 01224-010
        • Matern. Escola de Vila Nova Cachoeirinha
      • Sao Paulo, SP, Brazil, 05403-900
        • Instituto da Criança - HCFMUSP
      • Sao Paulo, SP, Brazil, 05508900
        • Hospital Universitário - USP
    • Sao Paulo
      • Botucatu, Sao Paulo, Brazil, 18601-020
        • Faculdade de Medicina de Botucatu - UNESP
      • Campinas, Sao Paulo, Brazil, 13083-881
        • Universidade de Campinas - UNICAMP
      • Ribeirão Preto, Sao Paulo, Brazil, 14049-900
        • HC da Fac. de Medicina de Ribeirão Preto - USP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 minute to 1 day (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Butantan
The new pulmonary surfactant produced by Butantan Institute. Butantan Surfactant: 100 mg/kg, IT, maximum of 3 doses.
Drug: Butantan
Use of Butantan surfactant 100 mg/kg, IT, maximum of 3 doses
Other Names:
  • Butantan Surfactant
Active Comparator: Control
The pulmonary surfactants commercially available in Brazil Survanta or Curosurf: 100 mg/kg, IT, maximum of 3 doses.
Drug: Control
The pulmonary surfactants commercially available in Brazil Survanta or Curosurf: 100 mg/kg, IT, maximum of 3 doses.
Other Names:
  • Survanta or Curosurf

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality rate
Time Frame: 72 hours after treatment
Mortality rate 72 hours after treatment
72 hours after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of adverse effects as: pneumothorax, pneumomediastinum, pulmonary interstitial emphysema, pulmonary hemorrhage and bronchopulmonary dysplasia (BPD).
Time Frame: 28 days of life
Incidence of main complications of prematurity at 28 days of life.
28 days of life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Collaborators

Ministry of Health, Brazil

Investigators

  • Study Director: Alexander R Precioso, MD PhD, University of Sao Paulo Medical School Department of Pediatrics
  • Principal Investigator: Celso M Rebello, MD PhD, University of Sao Paulo Medical School - Department of Pediatrics
  • Study Director: Renata S Mascaretti, MD PhD, University of Sao Paulo Medical School Department of Pediatrics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (Actual)

May 1, 2006

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

February 26, 2014

First Submitted That Met QC Criteria

November 26, 2014

First Posted (Estimate)

December 2, 2014

Study Record Updates

Last Update Posted (Estimate)

December 2, 2014

Last Update Submitted That Met QC Criteria

November 26, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 012005B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Respiratory Distress Syndrome

Clinical Trials on Butantan

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gabon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe