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

Phase 2

Completed

• Conditions: Respiratory Distress Syndrome
• Interventions: Drug: Butantan; Drug: Control

• Registration Number: NCT02305160
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2005-04
• Primary Completion: 2006-05
• Study Completion: 2007-07
• Study First Submitted: 2014-02-26
• Status Verified: 2014-11
• Study First Submitted QC: 2014-11-26
• Last Update Submitted: 2014-11-26
• Study First Posted: 2014-12-02
• Last Update Posted: 2014-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 327

Inclusion Criteria

• Gestational age below 34 weeks
• RDS diagnosis based on clinical and RDS radiographic patterns
• Need of mechanical ventilation
• Parental consent

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Butantan	Butantan	The new pulmonary surfactant produced by Butantan Institute. Butantan Surfactant: 100 mg/kg, IT, maximum of 3 doses.
Control	Control	The pulmonary surfactants commercially available in Brazil Survanta or Curosurf: 100 mg/kg, IT, maximum of 3 doses.

Primary Outcome Measures

Name	Time	Method
Mortality rate	72 hours after treatment	Mortality rate 72 hours after treatment

Secondary Outcome Measures

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

Trial Locations

Locations (30)

Hospital Esau de Matos; 🇧🇷 Vitoria da Conquista, BA, Brazil

Hospital Regional de Taguatinga; 🇧🇷 Brasilia, DF, Brazil

Hospital Materno Infantil; 🇧🇷 Goiania, GO, Brazil

Maternidade Odete Valadares; 🇧🇷 Belo Horizonte, MG, Brazil

Hospital Universitario - Unidade Materno Infantil; 🇧🇷 Sao Luis, MA, Brazil

Hospital Sofia feldman; 🇧🇷 Belo Horizonte, MG, Brazil

Hospital de Clínicas de Minas Gerais; 🇧🇷 Belo Horizonte, MG, Brazil

Santa Casa de Misericórdia de BH; 🇧🇷 Belo Horizonte, MG, Brazil

Hospital Municipal Odilon Behrens; 🇧🇷 Belo Horizonte, MG, Brazil

Hospital Julia Kubstchek; 🇧🇷 Belo Horizonte, MG, Brazil

IMIP; 🇧🇷 Recife, PE, Brazil

Hospital Maternidade Oswaldo de Nazareth; 🇧🇷 Rio de janeiro, RJ, Brazil

Hospital Barao de Lucena; 🇧🇷 Recife, PE, Brazil

CISAM - Universidade de Pernambuco; 🇧🇷 Recife, PE, Brazil

Hospital Maternidade Carmela Dutra; 🇧🇷 Rio de Janeiro, RJ, Brazil

Hospital Maternidade Alexandre Fleming; 🇧🇷 Rio de Janeiro, RJ, Brazil

Hospital Geral de Bonsucesso; 🇧🇷 Rio de Janeiro, RJ, Brazil

Instituto Fernandes Figueira; 🇧🇷 Rio de Janeiro, RJ, Brazil

Hospital Femina; 🇧🇷 Porto Alegre, RS, Brazil

Grupo Hospital Criança Conceicao; 🇧🇷 Porto Alegre, RS, Brazil

Hospital Cachoeirinha; 🇧🇷 Cachoeirinha, RS, Brazil

Hospital Alvorada; 🇧🇷 Porto Alegre, RS, Brazil

Maternidade Hildete Falcao Batista; 🇧🇷 Aracaju, SE, Brazil

Faculdade de Medicina de Botucatu - UNESP; 🇧🇷 Botucatu, Sao Paulo, Brazil

Universidade de Campinas - UNICAMP; 🇧🇷 Campinas, Sao Paulo, Brazil

Hospital Universitario - USP; 🇧🇷 Sao Paulo, SP, Brazil

Matern. Escola de Vila Nova Cachoeirinha; 🇧🇷 Sao Paulo, SP, Brazil

HC da Fac. de Medicina de Ribeirão Preto - USP; 🇧🇷 Ribeirão Preto, Sao Paulo, Brazil

Hospital Santa Isabel; 🇧🇷 Aracaju, SE, Brazil

Instituto da Criança - HCFMUSP; 🇧🇷 Sao Paulo, SP, Brazil