Effects of Continuous Positive Airway Pressure (CPAP) Delivered by High Flow Nasal Cannula Versus Nasal Continuous Positive Airway Pressure on the Diaphragm Electrical Activity in Very Low Birth Weight Preterm Infants
Sponsor study identifier
observational
10
1 country
1
Study Start
May 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2012
Actual (reported)Study Completion
December 2012
Actual (reported)In this study, the investigators want to observe how continuous positive airway pressure delivered by two different modalities affects breathing pattern in small preterm infants. Using a specialized feeding tube in the stomach, the investigators can measure and compare how the diaphragm (a large breathing muscle) might be affected by those two modalities.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2012
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 23, 2011
Actual (reported)March 31, 2011
Actual (reported)May 2011
Date type not reportedThis date has not been verified as actual or estimated.
November 2012
Actual (reported)December 2012
Actual (reported)The difference in the tonic EAdi between IF-CPAP and HFNC .
Patients will be randomized in two groups, one group will start on IF-CPAP for 30 minutes. After another 45 minutes, this group will be switched to HFNC for another 30 minutes. The other group will start on HFNC and then switched to IF-CPAP. EAdi will be analyzed in the last 15 minutes of each 30 minutes period.
During the 4-hour study period.
Difference in the number of apnea episodes (breathing pauses) on EAdi recorded with each modality.
During the 4-hour study period.
Difference in episodes of clinically significant apnea with HFNC and IF-CPAP.
During the 4-hour study period.
Indices of respiratory muscle effort (inspiratory and expiratory) will be calculated from Edi waveform.
During the 4-hour study period.
babies in this group will first receive CPAP through IF-CPAP for 30 minutes. After another 45 minutes, they will be switched to HFNC for 30 minutes. EAdi will be recorded for the last 15 minutes of each 30 minutes period.
babies in this group will first receive CPAP through HFNC for 30 minutes. After another 45 minutes, they will be switched to IF-CPAP for 30 minutes. EAdi will be recorded for the last 15 minutes of each 30 minutes period.
clinically stable preterm infants with birth weight less than 1.5 kilograms and gestational age less than 32 weeks admitted to the neonatal intensive care unit at Sunnybrook Health Sciences centre on nasal continuos positive airway pressure(CPAP) of 5-6 cmH2O support for at least 48 hours, treated with Methylxanthines for apnea of prematurity and in less than 35% oxygen.
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Nehad Nasef, M.B.B.Ch
Sunnybrook Health Sciences Centre
Maureen Reilly, RRT
Sunnybrook Health Sciences Centre
Patti Schurr, RN(EC)
Sunnybrook Health Sciences Centre
Michael Dunn, MD
Sunnybrook Health Sciences Centre
First Submitted
March 23, 2011
First Posted
March 31, 2011
Study Start
May 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2012
Actual (reported)Effects of a Therapeutic Education Program on Treatment Adherence Among Patients Prescribed At-home CPAP or At-home NIV
Contact the study team to confirm eligibility.
Jennifer Beck, Ph.D.
Unity Health Toronto
Eugene Ng, MD
Sunnybrook Health Sciences Centre
Study Completion
December 2012
Actual (reported)Last Updated
June 18, 2015
Record last verified: 2015-06
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