Crossover Comparison of Tidal Volume Delivery During Nasal Intermittent Positive Pressure Ventilation in Preterm Infants: Infant Cannula vs. Nasal Continuous Positive Airway Pressure Prongs
Primary Purpose
Respiratory Distress Syndrome in Premature Infant
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nasal interface
Sponsored by
About this trial
This is an interventional treatment trial for Respiratory Distress Syndrome in Premature Infant focused on measuring nasal intermittent positive pressure ventilation, non-invasive ventilation, nasal continuous positive airway pressure prongs, infant nasal cannula, tidal volume
Eligibility Criteria
Inclusion Criteria:
- Chronologic age less than 28 days
- Gestational age at birth between 24 weeks 0 days to 34 weeks 6 days
- Currently receiving NIPPV, NIV NAVA, or nCPAP
Exclusion Criteria:
- Oxygen requirement greater than 40%
- Peak inspiratory pressure greater than 20 cm H2O
- Major congenital anomalies of the heart or lungs
Sites / Locations
- Arkansas Children's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
nCPAP prongs
Infant cannula
Arm Description
Outcomes
Primary Outcome Measures
Relative tidal volume delivery, breath type I
Relative tidal volume measured in arbitrary units (AU) via RIP bands during synchronized breaths
Relative tidal volume delivery, breath type II
Relative tidal volume measured in arbitrary units (AU) via RIP bands during ventilator-driven breaths
Relative tidal volume delivery, breath type III
Relative tidal volume measured in arbitrary units (AU) via RIP bands during patient-driven breaths
Secondary Outcome Measures
Ventilator pressure delivery
Ventilator flow delivery
Heart rate
Oxygen saturation
Transcutaneous carbon dioxide tension
Transcutaneous oxygen tension
Full Information
NCT ID
NCT04326270
First Posted
March 26, 2020
Last Updated
March 26, 2020
Sponsor
Arkansas Children's Hospital Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT04326270
Brief Title
Crossover Comparison of Tidal Volume Delivery During Nasal Intermittent Positive Pressure Ventilation in Preterm Infants: Infant Cannula vs. Nasal Continuous Positive Airway Pressure Prongs
Official Title
Crossover Comparison of Tidal Volume Delivery During Nasal Intermittent Positive Pressure Ventilation in Preterm Infants: Infant Cannula vs. Nasal Continuous Positive Airway Pressure Prongs
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 7, 2019 (Actual)
Primary Completion Date
June 30, 2020 (Anticipated)
Study Completion Date
June 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Arkansas Children's Hospital Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Crossover bedside clinical study to examine relative tidal volume delivery during nasal intermittent positive pressure ventilation (NIPPV) and directly compare the RAM® infant cannula to a nasal continuous positive airway pressure (nCPAP) delivery system in vivo. The study population will consist of preterm neonates with mild respiratory insufficiency who are receiving NIPPV, non-invasive neurally adjusted ventilatory assist (NIV NAVA), or nCPAP.
Detailed Description
Bedside crossover study of neonates with mild respiratory distress receiving NIPPV. Infants serve as their own controls and are randomized to initial interface of either RAM® infant cannula or Miniflow® nCPAP prongs. Infants are instrumented with the following monitoring equipment: Edi orogastric tube to measure electrical activity of the diaphragm, transcutaneous monitor to measure transcutaneous CO2 and O2, pulse oximeter to measure heart rate and oxygen saturation, and respiratory inductance plethysmography (RIP) bands around the chest and abdomen to measure breathing movements and relative Vt (arbitrary units, a.u.). Data are continuously and simultaneously acquired using a data acquisition system. After 10 minutes of stabilization, infants receive 5 minutes of NIPPV on each of a sequence of four commonly used pressure settings (expressed as peak inspiratory pressure / positive end expiratory pressure): 16/5, 16/8, 20/5, 20/8. This sequence is not randomized and is constant between interfaces. Subjects are then placed on the alternate interface, and the sequence is repeated. Events ("breaths") are separated into 3 types: patient effort synchronized with NIPPV breaths (type I), NIPPV breaths without patient effort (type II), and patient effort without NIPPV breaths (type III).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome in Premature Infant
Keywords
nasal intermittent positive pressure ventilation, non-invasive ventilation, nasal continuous positive airway pressure prongs, infant nasal cannula, tidal volume
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
nCPAP prongs
Arm Type
Active Comparator
Arm Title
Infant cannula
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Nasal interface
Other Intervention Name(s)
Neotech RAM infant cannula, Miniflow Nasal CPAP Prongs
Intervention Description
Randomized to initial interface of nCPAP prongs or infant cannula
Primary Outcome Measure Information:
Title
Relative tidal volume delivery, breath type I
Description
Relative tidal volume measured in arbitrary units (AU) via RIP bands during synchronized breaths
Time Frame
1 hour
Title
Relative tidal volume delivery, breath type II
Description
Relative tidal volume measured in arbitrary units (AU) via RIP bands during ventilator-driven breaths
Time Frame
1 hour
Title
Relative tidal volume delivery, breath type III
Description
Relative tidal volume measured in arbitrary units (AU) via RIP bands during patient-driven breaths
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Ventilator pressure delivery
Time Frame
1 hour
Title
Ventilator flow delivery
Time Frame
1 hour
Title
Heart rate
Time Frame
1 hour
Title
Oxygen saturation
Time Frame
1 hour
Title
Transcutaneous carbon dioxide tension
Time Frame
1 hour
Title
Transcutaneous oxygen tension
Time Frame
1 hour
10. Eligibility
Sex
All
Maximum Age & Unit of Time
28 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chronologic age less than 28 days
Gestational age at birth between 24 weeks 0 days to 34 weeks 6 days
Currently receiving NIPPV, NIV NAVA, or nCPAP
Exclusion Criteria:
Oxygen requirement greater than 40%
Peak inspiratory pressure greater than 20 cm H2O
Major congenital anomalies of the heart or lungs
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ashley Lynch, M.D.
Phone
501-412-0988
Email
allynch@uams.edu
Facility Information:
Facility Name
Arkansas Children's Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashley Lynch, M.D.
Phone
501-412-0988
Email
allynch@uams.edu
First Name & Middle Initial & Last Name & Degree
Ashley L Lynch, M.D.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Crossover Comparison of Tidal Volume Delivery During Nasal Intermittent Positive Pressure Ventilation in Preterm Infants: Infant Cannula vs. Nasal Continuous Positive Airway Pressure Prongs
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