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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

327 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2007-07-31

Brief Summary

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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

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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.

Conditions

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Respiratory Distress Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Butantan

The new pulmonary surfactant produced by Butantan Institute. Butantan Surfactant: 100 mg/kg, IT, maximum of 3 doses.

Group Type EXPERIMENTAL

Butantan

Intervention Type DRUG

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.

Group Type ACTIVE_COMPARATOR

Control

Intervention Type DRUG

The pulmonary surfactants commercially available in Brazil Survanta or Curosurf: 100 mg/kg, IT, maximum of 3 doses.

Interventions

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Butantan

Use of Butantan surfactant 100 mg/kg, IT, maximum of 3 doses

Intervention Type DRUG

Control

The pulmonary surfactants commercially available in Brazil Survanta or Curosurf: 100 mg/kg, IT, maximum of 3 doses.

Intervention Type DRUG

Other Intervention Names

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Butantan Surfactant Survanta or Curosurf

Eligibility Criteria

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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

Minimum Eligible Age

1 Minute

Maximum Eligible Age

24 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Celso Moura Rebello

MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alexander R Precioso, MD PhD

Role: STUDY_DIRECTOR

University of Sao Paulo Medical School Department of Pediatrics

Celso M Rebello, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo Medical School - Department of Pediatrics

Renata S Mascaretti, MD PhD

Role: STUDY_DIRECTOR

University of Sao Paulo Medical School Department of Pediatrics

Locations

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Hospital Esau de Matos

Vitória da Conquista, Estado de Bahia, Brazil

Site Status

Hospital Regional de Taguatinga

Brasília, Federal District, Brazil

Site Status

Hospital Materno Infantil

Goiânia, Goiás, Brazil

Site Status