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

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

327

Participants

Timeline

Start Date

April 30, 2005

Primary Completion Date

May 31, 2006

Study Completion Date

July 31, 2007

Conditions
Respiratory Distress Syndrome
Interventions
DRUG

Butantan

Use of Butantan surfactant 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.

Trial Locations (30)

45065-540

Hospital Esau de Matos, Vitória da Conquista

70673-423

Hospital Regional de Taguatinga, Brasília

74673-200

Hospital Materno Infantil, Goiânia

65020-460

Hospital Universitario - Unidade Materno Infantil, São Luís

30110-130

Maternidade Odete Valadares, Belo Horizonte

30140-080

Santa Casa de Misericórdia de BH, Belo Horizonte

30180-112

Hospital de Clínicas de Minas Gerais, Belo Horizonte

30260-020

Hospital Sofia feldman, Belo Horizonte

30575-740

Hospital Municipal Odilon Behrens, Belo Horizonte

30620-470

Hospital Julia Kubstchek, Belo Horizonte

50070-550

IMIP, Recife

50731-000

Hospital Barao de Lucena, Recife

52030-010

CISAM - Universidade de Pernambuco, Recife

20010-010

Hospital Maternidade Oswaldo de Nazareth, Rio de Janeiro

20720-292

Hospital Maternidade Carmela Dutra, Rio de Janeiro

21610-645

Hospital Maternidade Alexandre Fleming, Rio de Janeiro

22040-000

Hospital Geral de Bonsucesso, Rio de Janeiro

22250-020

Instituto Fernandes Figueira, Rio de Janeiro

94950-585

Hospital Cachoeirinha, Cachoeirinha

91430-001

Hospital Femina, Porto Alegre

Unknown

Grupo Hospital Criança Conceicao, Porto Alegre

Hospital Alvorada, Porto Alegre

49060-640

Hospital Santa Isabel, Aracaju

49085-310

Maternidade Hildete Falcao Batista, Aracaju

18601-020

Faculdade de Medicina de Botucatu - UNESP, Botucatu

13083-881

Universidade de Campinas - UNICAMP, Campinas

14049-900

HC da Fac. de Medicina de Ribeirão Preto - USP, Ribeirão Preto

01224-010

Matern. Escola de Vila Nova Cachoeirinha, São Paulo

05403-900

Instituto da Criança - HCFMUSP, São Paulo

05508900

Hospital Universitario - USP, São Paulo

All Listed Sponsors
collaborator

Ministry of Health, Brazil

OTHER_GOV

lead

University of Sao Paulo

OTHER

NCT02305160 - A Multicenter, Randomized, Open Label Trial of a New Animal Extracted Surfactant to Treat RDS in Preterm Infants | Biotech Hunter | Biotech Hunter