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Trial record 10 of 13 for:    "Lung Disease" | "Beractant"

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

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ClinicalTrials.gov Identifier: NCT02305160
Recruitment Status : Completed
First Posted : December 2, 2014
Last Update Posted : December 2, 2014
Sponsor:
Collaborator:
Ministry of Health, Brazil
Information provided by (Responsible Party):
Celso Moura Rebello, University of Sao Paulo

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, comparing to the pulmonary surfactants commercially available in Brazil.

Condition or disease Intervention/treatment Phase
Respiratory Distress Syndrome Drug: Butantan Drug: Control Phase 2 Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 327 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 3 Multicenter, Randomized, Open Label Trial of a New Low Cost Animal Extracted Surfactant to Treat Respiratory Distress Syndrome in Preterm Infants
Study Start Date : April 2005
Actual Primary Completion Date : May 2006
Actual Study Completion Date : July 2007


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 Name: 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 Name: Survanta or Curosurf




Primary Outcome Measures :
  1. Mortality rate [ Time Frame: 72 hours after treatment ]
    Mortality rate 72 hours after treatment


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   up to 24 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02305160


Locations
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Brazil
Hospital Esau de Matos
Vitoria da Conquista, BA, Brazil, 45065-540
Hospital Regional de Taguatinga
Brasilia, DF, Brazil, 70673-423
Hospital Materno Infantil
Goiania, GO, Brazil, 74673-200
Hospital Universitario - Unidade Materno Infantil
Sao Luis, MA, Brazil, 65020-460
Maternidade Odete Valadares
Belo Horizonte, MG, Brazil, 30110-130
Santa Casa de Misericórdia de BH
Belo Horizonte, MG, Brazil, 30140-080
Hospital de Clínicas de Minas Gerais
Belo Horizonte, MG, Brazil, 30180-112
Hospital Sofia feldman
Belo Horizonte, MG, Brazil, 30260-020
Hospital Municipal Odilon Behrens
Belo Horizonte, MG, Brazil, 30575-740
Hospital Julia Kubstchek
Belo Horizonte, MG, Brazil, 30620-470
IMIP
Recife, PE, Brazil, 50070-550
Hospital Barao de Lucena
Recife, PE, Brazil, 50731-000
CISAM - Universidade de Pernambuco
Recife, PE, Brazil, 52030-010
Hospital Maternidade Oswaldo de Nazareth
Rio de janeiro, RJ, Brazil, 20010-010
Hospital Maternidade Carmela Dutra
Rio de Janeiro, RJ, Brazil, 20720-292
Hospital Maternidade Alexandre Fleming
Rio de Janeiro, RJ, Brazil, 21610-645
Hospital Geral de Bonsucesso
Rio de Janeiro, RJ, Brazil, 22040-000
Instituto Fernandes Figueira
Rio de Janeiro, RJ, Brazil, 22250-020
Hospital Cachoeirinha
Cachoeirinha, RS, Brazil, 94950-585
Hospital Femina
Porto Alegre, RS, Brazil, 91430-001
Grupo Hospital Criança Conceicao
Porto Alegre, RS, Brazil
Hospital Alvorada
Porto Alegre, RS, Brazil
Faculdade de Medicina de Botucatu - UNESP
Botucatu, Sao Paulo, Brazil, 18601-020
Universidade de Campinas - UNICAMP
Campinas, Sao Paulo, Brazil, 13083-881
HC da Fac. de Medicina de Ribeirão Preto - USP
Ribeirão Preto, Sao Paulo, Brazil, 14049-900
Hospital Santa Isabel
Aracaju, SE, Brazil, 49060-640
Maternidade Hildete Falcao Batista
Aracaju, SE, Brazil, 49085-310
Matern. Escola de Vila Nova Cachoeirinha
Sao Paulo, SP, Brazil, 01224-010
Instituto da Criança - HCFMUSP
Sao Paulo, SP, Brazil, 05403-900
Hospital Universitario - USP
Sao Paulo, SP, Brazil, 05508900
Sponsors and Collaborators
University of Sao Paulo
Ministry of Health, Brazil
Investigators
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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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Celso Moura Rebello, MD PhD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02305160     History of Changes
Other Study ID Numbers: 012005B
First Posted: December 2, 2014    Key Record Dates
Last Update Posted: December 2, 2014
Last Verified: November 2014
Keywords provided by Celso Moura Rebello, University of Sao Paulo:
Respiratory distress syndrome
Pulmonary surfactant
Mortality
Prematurity
Additional relevant MeSH terms:
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Lung Diseases
Beractant
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Syndrome
Disease
Pathologic Processes
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Pulmonary Surfactants
Poractant alfa
Respiratory System Agents