Clinical trial NCT02305160: A Multicenter, Randomized, Open Label Trial of a New Animal Extracted Surfactant to Treat RDS in Preterm Infants
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Respiratory Distress Syndrome
Keywords: Respiratory distress syndrome
Pulmonary surfactant
Mortality
Prematurity
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Brazil
First posted: 2014-12-02
Enrollment: 327
Sex: ALL
Minimum age (years): 1
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Mortality rate
timeFrame: 72 hours after treatment
Secondary outcomes:
measure: The incidence of adverse effects as: pneumothorax, pneumomediastinum, pulmonary interstitial emphysema, pulmonary hemorrhage and bronchopulmonary dysplasia (BPD).
timeFrame: 28 days of life
Other outcomes:
Locations:
city: Vitoria da Conquista
country: Brazil
facility: Hospital Esau de Matos
state: BA
city: Brasilia
country: Brazil
facility: Hospital Regional de Taguatinga
state: DF
city: Goiania
country: Brazil
facility: Hospital Materno Infantil
state: GO
city: Sao Luis
country: Brazil
facility: Hospital Universitario - Unidade Materno Infantil
state: MA
city: Belo Horizonte
country: Brazil
facility: Maternidade Odete Valadares
state: MG
city: Belo Horizonte
country: Brazil
facility: Santa Casa de Misericórdia de BH
state: MG
city: Belo Horizonte
country: Brazil
facility: Hospital de Clínicas de Minas Gerais
state: MG
city: Belo Horizonte
country: Brazil
facility: Hospital Sofia feldman
state: MG
city: Belo Horizonte
country: Brazil
facility: Hospital Municipal Odilon Behrens
state: MG
city: Belo Horizonte
country: Brazil
facility: Hospital Julia Kubstchek
state: MG
city: Recife
country: Brazil
facility: IMIP
state: PE
city: Recife
country: Brazil
facility: Hospital Barao de Lucena
state: PE
city: Recife
country: Brazil
facility: CISAM - Universidade de Pernambuco
state: PE
city: Rio de janeiro
country: Brazil
facility: Hospital Maternidade Oswaldo de Nazareth
state: RJ
city: Rio de Janeiro
country: Brazil
facility: Hospital Maternidade Carmela Dutra
state: RJ
city: Rio de Janeiro
country: Brazil
facility: Hospital Maternidade Alexandre Fleming
state: RJ
city: Rio de Janeiro
country: Brazil
facility: Hospital Geral de Bonsucesso
state: RJ
city: Rio de Janeiro
country: Brazil
facility: Instituto Fernandes Figueira
state: RJ
city: Cachoeirinha
country: Brazil
facility: Hospital Cachoeirinha
state: RS
city: Porto Alegre
country: Brazil
facility: Hospital Femina
state: RS
city: Porto Alegre
country: Brazil
facility: Grupo Hospital Criança Conceicao
state: RS
city: Porto Alegre
country: Brazil
facility: Hospital Alvorada
state: RS
city: Botucatu
country: Brazil
facility: Faculdade de Medicina de Botucatu - UNESP
state: Sao Paulo
city: Campinas
country: Brazil
facility: Universidade de Campinas - UNICAMP
state: Sao Paulo
city: Ribeirão Preto
country: Brazil
facility: HC da Fac. de Medicina de Ribeirão Preto - USP
state: Sao Paulo
city: Aracaju
country: Brazil
facility: Hospital Santa Isabel
state: SE
city: Aracaju
country: Brazil
facility: Maternidade Hildete Falcao Batista
state: SE
city: Sao Paulo
country: Brazil
facility: Matern. Escola de Vila Nova Cachoeirinha
state: SP
city: Sao Paulo
country: Brazil
facility: Instituto da Criança - HCFMUSP
state: SP
city: Sao Paulo
country: Brazil
facility: Hospital Universitario - USP
state: SP
Study officials:
affiliation: University of Sao Paulo Medical School Department of Pediatrics
name: Alexander R Precioso, MD PhD
role: STUDY_DIRECTOR
affiliation: University of Sao Paulo Medical School - Department of Pediatrics
name: Celso M Rebello, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sao Paulo Medical School Department of Pediatrics
name: Renata S Mascaretti, MD PhD
role: STUDY_DIRECTOR
References:
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. doi: 10.1590/s1807-59322006000200011. Epub 2006 Apr 25.
citation: 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.
citation: Rebello 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.