Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00187434
Status:
UNKNOWN
Last Update Posted:
2007-01-23
First Post:
2005-09-14
Brief Title:
Comparison of Two Methods of Continuous Positive Airway Pressure CPAP to Support Successful Extubation of Infants of Birth Weights 1500 Grams C2CPAP
Sponsor:
Sunnybrook Health Sciences Centre
Organization:
Sunnybrook Health Sciences Centre
Study Overview
Official Title:
A Randomized Control Trial Comparing Two Methods of Delivering Continuous Positive Airway Pressure CPAP Infant Flow System CPAP and Bubble CPAP in Supporting Successful Extubation of Infants of Birth Weights Less Than or Equal to 1500 Grams at Birth C2CPAP
Status:
UNKNOWN
Status Verified Date:
2005-09
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:
Continuous positive airway pressure CPAP has been used successfully to promote extubation in the premature infant population The two methods of CPAP to be examined are currently used by many institutions yet no study has compared these methods to determine which is better in the population of newborns 1500 grams birth weight at supporting extubation This randomised controlled study will examine two types of CPAP the Infant Flow System and the Bubble CPAP This randomised controlled single site clinical study is to determine whether the Bubble CPAP or the Infant Flow System IFS CPAP is more effective at supporting the extubation in infants of birth weights 1500 grams Seventy-six infants will be randomised immediately prior to extubation to IFS or Bubble CPAP of 5 cmH2O The primary outcome is successful extubation defined as not reaching failure criteria for the 7 days post-extubation Failure criteria are defined as pH 725 and PCO2 65 mmHg or a sustained increase in FiO2 of 015
Detailed Description:
Background Continuous Positive Airway Pressure CPAP has been used successfully to promote extubation in the premature infant population Davis Henderson-Smart 2002 The two methods of CPAP to be examined are used by many institutions yet no study has compared these methods to determine which is better in the population of newborns 1500 grams birth weight at supporting extubation This study may have cost savings implications If bubble CPAP is shown to be as effective in this application neonatal intensive care units NICUs will have a more affordable option of providing effective CPAP
Methods This randomised controlled single site clinical study is to determine if Bubble CPAP or Infant Flow System IFS CPAP is more effective at supporting extubation in infants of birth weights 1500 grams Seventy-six infants will be randomised immediately prior to extubation to IFS or Bubble CPAP of 5 cmH2O The primary outcome is successful extubation defined as not reaching failure criteria for the 7 days post-extubation Failure criteria are defined as pH 725 and PCO2 65 mmHg or a sustained increase in FiO2 of 015
Participants Parentsguardians of eligible infants will be approached and given information regarding the study and any questions answered They will then be allowed to consider study participation in private The recruiter will return at an agreed time and informed consent will be obtained from those agreeing to participate Parents will be approached in accordance with the guidelines of the NICU SWCHSC Infants are eligible if birth weight 1500 grams are to be extubated to CPAP and have no known airway anomalies or suspected genetic anomalies
Analysis Multiple ANOVA analysis will be used for continuous variables chi-square for categorical variables including primary outcome
Conclusion The results of this study will determine which method of CPAP is the best method of supporting extubation in the 1500 g infant
Methods This randomised controlled single site clinical study is to determine if Bubble CPAP or Infant Flow System IFS CPAP is more effective at supporting extubation in infants of birth weights 1500 grams Seventy-six infants will be randomised immediately prior to extubation to IFS or Bubble CPAP of 5 cmH2O The primary outcome is successful extubation defined as not reaching failure criteria for the 7 days post-extubation Failure criteria are defined as pH 725 and PCO2 65 mmHg or a sustained increase in FiO2 of 015
Participants Parentsguardians of eligible infants will be approached and given information regarding the study and any questions answered They will then be allowed to consider study participation in private The recruiter will return at an agreed time and informed consent will be obtained from those agreeing to participate Parents will be approached in accordance with the guidelines of the NICU SWCHSC Infants are eligible if birth weight 1500 grams are to be extubated to CPAP and have no known airway anomalies or suspected genetic anomalies
Analysis Multiple ANOVA analysis will be used for continuous variables chi-square for categorical variables including primary outcome
Conclusion The results of this study will determine which method of CPAP is the best method of supporting extubation in the 1500 g infant
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