Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00368680
Status:
UNKNOWN
Last Update Posted:
2010-12-24
First Post:
2006-08-24
Brief Title:
Early CPAP in Respiratory Distress Syndrome
Sponsor:
Pontificia Universidad Catolica de Chile
Organization:
Pontificia Universidad Catolica de Chile
Study Overview
Official Title:
Early Bubble CPAP EBCPAP in Very Low Birth Weight Infants VLBWI
Status:
UNKNOWN
Status Verified Date:
2007-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 distressMany 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
Comparisons
Early Bubble CPAP EBCPAPwith Standard Therapy which is oxygen
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
Comparisons
Early Bubble CPAP EBCPAPwith Standard Therapy which is oxygen
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None