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

Study Overview
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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.

Official Title
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Phase 3 Multicenter, Randomized, Open Label Trial of a New Low Cost Animal Extracted Surfactant to Treat Respiratory Distress Syndrome in Preterm Infants

Conditions
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Respiratory Distress Syndrome

Intervention / Treatment
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* Drug: Butantan
* Drug: Control


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Minute
Maximum Age: 24 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Butantan<br>The new pulmonary surfactant produced by Butantan Institute. Butantan Surfactant: 100 mg/kg, IT, maximum of 3 doses. | Drug: Butantan<br>* Use of Butantan surfactant 100 mg/kg, IT, maximum of 3 doses<br>* Other names: Butantan Surfactant;|
| Active Comparator: Control<br>The pulmonary surfactants commercially available in Brazil Survanta or Curosurf: 100 mg/kg, IT, maximum of 3 doses. | Drug: Control<br>* The pulmonary surfactants commercially available in Brazil Survanta or Curosurf: 100 mg/kg, IT, maximum of 3 doses.<br>* Other names: Survanta or Curosurf;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality rate | Mortality rate 72 hours after treatment | 72 hours after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Respiratory distress syndrome, Pulmonary surfactant, Mortality, Prematurity