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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
256
Servicio de Neonatología, Hospital de Clínicas José de San Martín
Buenos Aires, Argentina
RECRUITINGServicio de Neonatología, Hospital Fernández
Need for mechanical ventilation
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.
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