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

Respiratory Distress Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02305160
• Other study ID #: 012005B
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: February 26, 2014
• Last updated: November 26, 2014
• Start date: April 2005
• Est. completion date: July 2007

Study information

• Verified date: November 2014
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of HealthBrazil: National Committee of Ethics in ResearchBrazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 327
• Est. completion date: July 2007
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 24 Hours

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Drug:
• Butantan
Use of Butantan surfactant 100 mg/kg, IT, maximum of 3 doses
• Control
The pulmonary surfactants commercially available in Brazil Survanta or Curosurf: 100 mg/kg, IT, maximum of 3 doses.

Locations

Country	Name	City	State
Brazil	Hospital Santa Isabel	Aracaju	SE
Brazil	Maternidade Hildete Falcao Batista	Aracaju	SE
Brazil	Hospital de Clínicas de Minas Gerais	Belo Horizonte	MG
Brazil	Hospital Julia Kubstchek	Belo Horizonte	MG
Brazil	Hospital Municipal Odilon Behrens	Belo Horizonte	MG
Brazil	Hospital Sofia feldman	Belo Horizonte	MG
Brazil	Maternidade Odete Valadares	Belo Horizonte	MG
Brazil	Santa Casa de Misericórdia de BH	Belo Horizonte	MG
Brazil	Faculdade de Medicina de Botucatu - UNESP	Botucatu	Sao Paulo
Brazil	Hospital Regional de Taguatinga	Brasilia	DF
Brazil	Hospital Cachoeirinha	Cachoeirinha	RS
Brazil	Universidade de Campinas - UNICAMP	Campinas	Sao Paulo
Brazil	Hospital Materno Infantil	Goiania	GO
Brazil	Grupo Hospital Criança Conceicao	Porto Alegre	RS
Brazil	Hospital Alvorada	Porto Alegre	RS
Brazil	Hospital Femina	Porto Alegre	RS
Brazil	CISAM - Universidade de Pernambuco	Recife	PE
Brazil	Hospital Barao de Lucena	Recife	PE
Brazil	IMIP	Recife	PE
Brazil	HC da Fac. de Medicina de Ribeirão Preto - USP	Ribeirão Preto	Sao Paulo
Brazil	Hospital Geral de Bonsucesso	Rio de Janeiro	RJ
Brazil	Hospital Maternidade Alexandre Fleming	Rio de Janeiro	RJ
Brazil	Hospital Maternidade Carmela Dutra	Rio de Janeiro	RJ
Brazil	Hospital Maternidade Oswaldo de Nazareth	Rio de janeiro	RJ
Brazil	Instituto Fernandes Figueira	Rio de Janeiro	RJ
Brazil	Hospital Universitario - Unidade Materno Infantil	Sao Luis	MA
Brazil	Hospital Universitario - USP	Sao Paulo	SP
Brazil	Instituto da Criança - HCFMUSP	Sao Paulo	SP
Brazil	Matern. Escola de Vila Nova Cachoeirinha	Sao Paulo	SP
Brazil	Hospital Esau de Matos	Vitoria da Conquista	BA

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Ministry of Health, Brazil

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

Lyra 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. — View Citation

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. Epub 2006 Apr 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality rate	Mortality rate 72 hours after treatment	72 hours after treatment	Yes
Secondary	The incidence of adverse effects as: pneumothorax, pneumomediastinum, pulmonary interstitial emphysema, pulmonary hemorrhage and bronchopulmonary dysplasia (BPD).	Incidence of main complications of prematurity at 28 days of life.	28 days of life	Yes