Ignite Creation Date:
2025-12-24 @ 12:10 PM
Ignite Modification Date:
2026-01-03 @ 3:06 PM
Study NCT ID:
NCT01024361
Status:
UNKNOWN
Last Update Posted:
2009-12-23
First Post:
2009-11-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cpap at Delivery Room for Preterm Infants
Sponsor:
University of Sao Paulo
Organization:
Study Overview
Official Title:
CPAP Application at Delivery Room at Very Low Birth Weight Infants
Status:
UNKNOWN
Status Verified Date:
2009-12
Last Known Status:
ACTIVE_NOT_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:
CPAP-DR
Brief Summary:
The objective of the study is to determine if CPAP applied within less than 15 min of life in the DR reduces the necessity of mechanical ventilation and surfactant during the first 5 days of life.
Detailed Description:
A multicenter prospective cohort of inborn preterm infants, born at 8 public university NICU in Brazil, with birthweight 1000-1499 g, without malformations, not intubated at 15 minutes of life. Preterm infants will be randomly assigned at birth to an early treatment group (DR-CPAP), in which CPAP of 5 cm water pressure is applied within 15 minutes after birth by Neopuff, or to a routine group (RG), in which CPAP is applied when indicated by the assistant physician. After transfer to the NICU, nasal CPAP will be maintained with Hudson prongs
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| FAPESP 06/61388-2 | OTHER_GRANT | FAPESP 06/61388-2 | View |