Respiratory Distress Syndrome
Conditions
Keywords
Respiratory Distress Syndrome, Early Bubble CPAP, Mechanical Ventilation, Surfactant
Brief summary
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
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.
Interventions
DEVICEEarly Bubble CPAP
Sponsors
Pontificia Universidad Catolica de Chile
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Minutes to 30 Minutes
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Need for mechanical ventilation | — |
Secondary
| Measure | Time frame |
|---|---|
| Days of mechanical ventilation | — |
| Need for surfactant | — |
| Pulmonary airleak | — |
| Days of oxygen therapy | — |
| Persistent ductus arteriosus | — |
| retinopathy of prematurity | — |
| Bronchopulmonary dysplasia (BPD) at 28 days and 36 weeks corrected gestational age. | — |
| Intraventricular hemorrhage | — |
Countries
Argentina, Chile, Paraguay, Peru, Uruguay
Contacts
Primary ContactJosé Luis Tapia, MD
Backup ContactSoledad Urzua, MD
Outcome results
None listed