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.
Full Title of Study: “Early Bubble CPAP (EBCPAP) in Very Low Birth Weight Infants (VLBWI)”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: April 2008
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.
- Device: Early Bubble CPAP
Clinical Trial Outcome Measures
- 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.
Participating in This Clinical Trial
- 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.
Gender Eligibility: All
Minimum Age: N/A
Maximum Age: 30 Minutes
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Pontificia Universidad Catolica de Chile
- Provider of Information About this Clinical Study
- Neonatologia, Hospital Clinico, Pontificia Universidad Catolica
- Overall Official(s)
- José Luis Tapia, MD, Principal Investigator, Pontificia Universidad Católica
- Aldo Bancalari, MD, Principal Investigator, Hospital Guillermo Grant
- Soledad Urzua, MD, Principal Investigator, Pontificia Universidad Católica
- Overall Contact(s)
- José Luis Tapia, MD, 56-2-3546437, firstname.lastname@example.org
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