Early CPAP in Respiratory Distress Syndrome

Study Overview
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Brief Summary
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The purpose of this study is to establish if a strategy of EBCPAP application in a subgroup of VLBWI, 800 to 1500g birthweight, decreases the need for mechanical ventilation in this group, without affecting mortality.

Detailed Description
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The application of CPAP has been described as an alternative respiratory support for premature newborns with respiratory distress.Many studies support that the early use of CPAP results in a better respiratory evolution and less need for mechanical ventilation. Hypothesis: - The hypothesis is that EBCPAP will decrease the need for this more invasive therapy. The primary endpoint in this multicenter controlled study is to establish if an strategy of EBCPAP application in a subgroup of VLBWI, 800 to 1500g birthweight, decreases the need for mechanical ventilation in this group, without affecting mortality. . As secondary outcome, the investigators will analyse: days of oxygen therapy, days of mechanical ventilation, need for surfactant , pulmonary airleak, intraventricular hemorrhage, persistent ductus arteriosus, retinopathy of prematurity and bronchopulmonary dysplasia (BPD) at 28 days and 36 weeks corrected gestational age. Comparison(s): Early Bubble CPAP (EBCPAP)with Standard Therapy which is oxygen.

Official Title
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Early Bubble CPAP (EBCPAP) in Very Low Birth Weight Infants (VLBWI)

Conditions
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Respiratory Distress Syndrome

Intervention / Treatment
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* Device: Early Bubble CPAP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All infants born at the units belonging to the South American Neocosur Network with a birthweight between 800 to 1500g and breathing spontaneously at birth or after hand bagging with Neopuff or transient intubation are eligible. An informed consent form should be obtained preferable prenatal. Exclusion Criteria: Acute life threatening congenital malformations or genetics diseases. Apgar score equal or less than 3 at 5 minutes Disapproval of informed consent.

Ages Eligible for Study
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Minimum Age: 5 Minutes
Maximum Age: 30 Minutes

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

| Intervention/Treatment |
| --- |
|Device: Early Bubble CPAP|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for mechanical ventilation |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days of oxygen therapy |  |  | 
| Days of mechanical ventilation |  |  | 
| Need for surfactant |  |  | 
| Pulmonary airleak |  |  | 
| Intraventricular hemorrhage |  |  | 
| Persistent ductus arteriosus |  |  | 
| retinopathy of prematurity |  |  | 
| Bronchopulmonary dysplasia (BPD) at 28 days and 36 weeks corrected gestational age. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Respiratory Distress Syndrome, Early Bubble CPAP, Mechanical Ventilation, Surfactant