Ignite Creation Date:
2025-12-26 @ 10:32 AM
Ignite Modification Date:
2025-12-31 @ 9:40 PM
Study NCT ID:
NCT01066728
Status:
COMPLETED
Last Update Posted:
2010-03-03
First Post:
2010-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CO2 Inhalation as a New Treatment Modality for Apnea of Prematurity
Sponsor:
University of Manitoba
Organization:
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2010-01
Last Known Status:
None
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 objective of the present proposed study is to discover whether, in the nursery setting, administration of low concentration inhaled CO2 (0.8%) for a prolonged period (3 days) can make breathing more regular with less apneic time than that observed with administration of theophylline. The hypothesis to be tested is that inhalation of low concentration CO2 (0.8%) will reduce apnea more effectively and will have fewer adverse side effects than theophylline.
Detailed Description:
1. To discover whether, in the nursery setting, continuous administration of a low concentration of inhaled CO2 (0.8%) for a prolonged period (3 days) can make breathing in preterm infants more regular with less apneic time than that observed with theophylline.
2. To discover whether inhalation of low CO2 decreases apneas, particularly prolonged apneas (\>20 seconds), more effectively than theophylline.
3. To discover whether short term (during hospitalization) and long term (2 years) adverse side effects are less pronounced with CO2 than with theophylline.
2. To discover whether inhalation of low CO2 decreases apneas, particularly prolonged apneas (\>20 seconds), more effectively than theophylline.
3. To discover whether short term (during hospitalization) and long term (2 years) adverse side effects are less pronounced with CO2 than with theophylline.
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?: