- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03212508
Comparison of Two Nasal Interface for CPAP in Preterm
Comparison of Two Nasal Interface for Continuous Distending Airway Pressure in Preterm Infants: RAM Nasal Cannula and Hudson Prongs
Study Overview
Status
Intervention / Treatment
Detailed Description
Objective:
To compare efficacy of delivering continuous distending pressure in preterm neonates using RAM cannula versus the standard prongs (Hudson prongs) by measuring intra-oral pressure. It is hypothesize that CPAP delivered with RAM cannula is comparable to pressure delivered via standard nasal interface in routine clinical practice; and the desired CPAP level is often not achieved in presence of variable leak from mouth irrespective of type of nasal interface.
Aim 1: Compare the level of CPAP in oral cavity between RAM cannula and Hudson prong nasal interface in preterm Hypothesis: The intraoral pressure with CPAP will not be different with use of RAM cannula or Hudson prong nasal interface
Aim 2: Evaluate the effect of nasal interface (RAM cannula and Hudson prong) on respiratory variables Hypothesis: There will be no difference in respiratory variables with CPAP delivered by RAM cannula compared to Hudson prongs.
Method:
This was a single center prospective study. Inclusion criteria: Any preterm with respiratory distress requiring CPAP but not mechanical ventilation or NIPPV was eligible for the study. 12 preterm infant more than 48 hours old and stable on bubble CPAP were recruited for the study Exclusion criteria: Infants with major congenital anomalies, neuromuscular disorders, upper airway anomalies, critically sick infants
CPHS approval and parental consent was obtained prior to enrollment in the study.
Each infant was studied for ~1 hour during which the oral pressure was measured while receiving CPAP with RAM nasal cannula interface and then with Hudson prongs. Blinding of the intervention (nasal interface) was not feasible because of the visible differences in the two nasal interfaces.
Procedure: Intra-oral pressure measured via a differential pressure transducer while infant in receiving CPAP, and digitized data recorded with each nasal interface ( goal to record at least 20 sec of stable waveform on each nasal interface). Standard care provided during the study period and no changes made with CPAP level or flow.
The difference between set pressure and measured pressure with RAM cannula and Hudson prong was compared with standard paired student t-test with 95% confidence limits. Difference in other variables will be similarly compared with t-test. STAT 12 will be used for statistical analysis.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Any preterm with respiratory distress requiring CPAP but not mechanical ventilation or NIPPV will be eligible for the study. We will recruit preterm infant more than 48 hours old and stable on bubble CPAP
Exclusion Criteria:
- Infants with major congenital anomalies, neuromuscular disorders, upper airway anomalies, critically sick infants
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Crossover
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The difference between set pressure and measured pressure with RAM cannula and Hudson prong
Time Frame: one hour
|
Intraoral pressure measure using a differential pressure transducer with RAM cannula and then with Hudson prongs
|
one hour
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00029410
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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