- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00636324
Level of Continuous Positive Airway Pressure (CPAP) in Preterm Infants After Extubation (L-CPAP Study) (L-CPAP)
Nasal Continuous Positive Airway Pressure in Preterm Infants After Extubation: Comparison of Different Levels of Pressure
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The use of nCPAP has been established as an effective respiratory support to prevent extubation failure and as treatment of other pulmonary diseases. An upsurge in its popularity has resulted in some controversial aspects, including the level of pressure to be used. The level that has been used in very preterm infants after extubation, which mostly came from anecdotal data, varies from 3 to 10 cmH2O.
Physiologic studies show higher nCPAP pressures improve lung mechanical properties. Though potential side effects have been of concern in practical application, there is no formal evidence supporting the concept that increased CPAP pressure results in a higher risk of complications. In relatively stable preterm infants, the range of optimal CPAP level needs to be established in order to adequately support the upper airway and lungs, without increasing complications secondary to the pressure applied. Given the uncertainty of the nCPAP pressure that should be used in very preterm infants, we conduct a randomized controlled trial to compare the effectiveness of two ranges of nCPAP pressure for post-extubation support in very preterm infants.
The purpose of this trial is to compare the rate of successful extubation of using the nasal CPAP level of 7 to 9 cmH2O compared to level of 4 to 6 cmH2O.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Birth weight 500 - 1,250 g
- On mechanical ventilation before 7 days of age
- First extubation before 14 days of age
Exclusion Criteria:
- Presence of lethal anomalies or upper airway abnormalities
- IVH, grade 3 or 4
- Neuromuscular disorders
- Receiving muscle relaxation at time of extubation
- Congenital heart disease, except for PDA
- GI problems resulting in a need to avoid gastric distension
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Nasal CPAP, level of 7 to 9 cmH2O
|
Apply nasal CPAP pressure of 7-9 H2O for the first 72 hours of extubation
Other Names:
|
Active Comparator: 2
Nasal CPAP, level 4 to 6 cmH2O
|
Apply nasal CPAP pressure of 4 to 6 cmH2O for the first 72 hours of extubation
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The rate of successful extubation within 72 hours of extubation
Time Frame: within 72 hours after extubation
|
within 72 hours after extubation
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The rate of successful extubation within 7 days of extubation
Time Frame: within 14 days after extubation
|
within 14 days after extubation
|
Number of days on nCPAP
Time Frame: within 14 days after extubation
|
within 14 days after extubation
|
Occurrence of air leak syndrome
Time Frame: within 14 days after extubation
|
within 14 days after extubation
|
Occurrence of IVH grade 3 or 4
Time Frame: within 14 days after extubation
|
within 14 days after extubation
|
Occurrence of traumatized nasal septum
Time Frame: within 14 days after extubation
|
within 14 days after extubation
|
Collaborators and Investigators
Investigators
- Principal Investigator: Giulherme M SantAnna, MD, Hamilton Health Sciences Corporation
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REB project # 07-047
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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