A Multicenter, Randomized, Open Label Trial of a New Animal Extracted Surfactant to Treat RDS in Preterm Infants
Phase 3 Multicenter, Randomized, Open Label Trial of a New Low Cost Animal Extracted Surfactant to Treat Respiratory Distress Syndrome in Preterm Infants
1 other identifier
interventional
327
1 country
30
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2005
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 26, 2014
CompletedFirst Posted
Study publicly available on registry
December 2, 2014
CompletedDecember 2, 2014
November 1, 2014
1.1 years
February 26, 2014
November 26, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mortality rate
Mortality rate 72 hours after treatment
72 hours after treatment
Secondary Outcomes (1)
The incidence of adverse effects as: pneumothorax, pneumomediastinum, pulmonary interstitial emphysema, pulmonary hemorrhage and bronchopulmonary dysplasia (BPD).
28 days of life
Study Arms (2)
Butantan
EXPERIMENTALThe new pulmonary surfactant produced by Butantan Institute. Butantan Surfactant: 100 mg/kg, IT, maximum of 3 doses.
Control
ACTIVE COMPARATORThe pulmonary surfactants commercially available in Brazil Survanta or Curosurf: 100 mg/kg, IT, maximum of 3 doses.
Interventions
Eligibility Criteria
You may qualify if:
- Gestational age below 34 weeks
- RDS diagnosis based on clinical and RDS radiographic patterns
- Need of mechanical ventilation
- Parental consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Sao Paulolead
- Ministry of Health, Brazilcollaborator
Study Sites (30)
Hospital Esau de Matos
Vitória da Conquista, Estado de Bahia, 45065-540, Brazil
Hospital Regional de Taguatinga
Brasília, Federal District, 70673-423, Brazil
Hospital Materno Infantil
Goiânia, Goiás, 74673-200, Brazil
Hospital Universitario - Unidade Materno Infantil
São Luís, Maranhão, 65020-460, Brazil
Maternidade Odete Valadares
Belo Horizonte, Minas Gerais, 30110-130, Brazil
Santa Casa de Misericórdia de BH
Belo Horizonte, Minas Gerais, 30140-080, Brazil
Hospital de Clínicas de Minas Gerais
Belo Horizonte, Minas Gerais, 30180-112, Brazil
Hospital Sofia feldman
Belo Horizonte, Minas Gerais, 30260-020, Brazil
Hospital Municipal Odilon Behrens
Belo Horizonte, Minas Gerais, 30575-740, Brazil
Hospital Julia Kubstchek
Belo Horizonte, Minas Gerais, 30620-470, Brazil
IMIP
Recife, Pernambuco, 50070-550, Brazil
Hospital Barao de Lucena
Recife, Pernambuco, 50731-000, Brazil
CISAM - Universidade de Pernambuco
Recife, Pernambuco, 52030-010, Brazil
Hospital Maternidade Oswaldo de Nazareth
Rio de Janeiro, Rio de Janeiro, 20010-010, Brazil
Hospital Maternidade Carmela Dutra
Rio de Janeiro, Rio de Janeiro, 20720-292, Brazil
Hospital Maternidade Alexandre Fleming
Rio de Janeiro, Rio de Janeiro, 21610-645, Brazil
Hospital Geral de Bonsucesso
Rio de Janeiro, Rio de Janeiro, 22040-000, Brazil
Instituto Fernandes Figueira
Rio de Janeiro, Rio de Janeiro, 22250-020, Brazil
Hospital Cachoeirinha
Cachoeirinha, Rio Grande do Sul, 94950-585, Brazil
Hospital Femina
Porto Alegre, Rio Grande do Sul, 91430-001, Brazil
Grupo Hospital Criança Conceicao
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Alvorada
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Santa Isabel
Aracaju, Sergipe, 49060-640, Brazil
Maternidade Hildete Falcao Batista
Aracaju, Sergipe, 49085-310, Brazil
Faculdade de Medicina de Botucatu - UNESP
Botucatu, São Paulo, 18601-020, Brazil
Universidade de Campinas - UNICAMP
Campinas, São Paulo, 13083-881, Brazil
HC da Fac. de Medicina de Ribeirão Preto - USP
Ribeirão Preto, São Paulo, 14049-900, Brazil
Matern. Escola de Vila Nova Cachoeirinha
São Paulo, São Paulo, 01224-010, Brazil
Instituto da Criança - HCFMUSP
São Paulo, São Paulo, 05403-900, Brazil
Hospital Universitario - USP
São Paulo, São Paulo, 05508900, Brazil
Related Publications (3)
Precioso AR, Sakae PP, Mascaretti RS, Kubrusly FS, Gebara VC, Iourtov D, Rebello CM, Vaz FA, Raw I. Analysis of the immunogenicity and stability of a porcine pulmonary surfactant preparation administered in rabbits. Clinics (Sao Paulo). 2006 Apr;61(2):153-60. doi: 10.1590/s1807-59322006000200011. Epub 2006 Apr 25.
PMID: 16680333BACKGROUNDLyra JC, Mascaretti RS, Precioso AR, Haddad LB, Mauad T, Vaz FA, Rebello CM. Polyethylene glycol addition does not improve exogenous surfactant function in an experimental model of meconium aspiration syndrome. Exp Lung Res. 2009 Feb;35(1):76-88. doi: 10.1080/01902140802415837.
PMID: 19191106BACKGROUNDRebello CM, Precioso AR, Mascaretti RS; Grupo Colaborativo do Estudo Brasileiro Multicentrico de Surfactante. A multicenter, randomized, double-blind trial of a new porcine surfactant in premature infants with respiratory distress syndrome. Einstein (Sao Paulo). 2014 Oct-Dec;12(4):397-404. doi: 10.1590/S1679-45082014AO3095.
PMID: 25628188DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD PhD
Study Record Dates
First Submitted
February 26, 2014
First Posted
December 2, 2014
Study Start
April 1, 2005
Primary Completion
May 1, 2006
Study Completion
July 1, 2007
Last Updated
December 2, 2014
Record last verified: 2014-11