Back to resultsPhysiological Changes With High-Flow Nasal Cannula
Primary Purpose
Respiratory Distress Syndrome in Premature Infant
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High flow nasal cannula
Nasal CPAP
Sponsored by
About this trial
This is an interventional supportive care trial for Respiratory Distress Syndrome in Premature Infant focused on measuring high flow nasal cannula, nasal cpap
Eligibility Criteria
Inclusion Criteria:
- 23 to 28+6 weeks gestational age at birth
- Corrected gestational age less than or equal to 30 weeks
- Over 72 hours of life
- Stable on Nasal CPAP of 5-7cm H20
- Hemodynamically stable
- Tolerating routine handling
- Nares size appropriate for Fisher & Paykel Optiflow Jr 2 HFNC size XS or small
- Successfully extubated for 12 hours after administration of surfactant
- Caffeine Citrate at a maintenance dose of 5 to 10 mg /kg
- Transcutaneous monitoring in place
- Stable blood gas (pH>/= 7.25 and PaCO2 <60 mmHg torr)
Exclusion Criteria:
- Prior pneumothorax or evidence of pulmonary interstitial emphysema.
- Prior or current pulmonary hemorrhage
- Congenital airway malformations
- Major cardiopulmonary malformations
- Congenital Diaphragmatic hernia or untreated bowel obstruction
- Poor respiratory drive unresponsive to CPAP therapy
- Requirement of a nCPAP of >8 cmH20 or FiO2 > 0.3 to maintain oxygen saturations between 90-95 percent.
- Receiving positive pressure breaths or SIPAP on prongs
- Conflicting clinical trial
- Clinically unstable per physician discretion
Sites / Locations
- Sharp Mary Birch Hospital for Women & Newborns
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Nasal CPAP - Period 1
High Flow Nasal Cannula (HFNC) - Period 2 & 3
Nasal CPAP - Period 4
Arm Description
Eligible infants stable on high flow nasal cannula (nCPAP) therapy of 5-7 cm H20 achieved with a ventilator, an underwater "bubble" system, or a variable-flow device will be enrolled. A data acquisition cart will be placed at the subject's bedside to collect hemodynamic and respiratory parameters measured including: Heart rate (HR), blood pressure (BP), respiratory rate (RR), fraction of inspired oxygen (FiO2), transcutaneous carbon dioxide (TcCO2), and peripheral oxygen saturation (SpO2) via bedside monitoring devices. A neonatal chest belt, sized to the infant's chest circumference (nipple level) using warmed ultrasound gel applied to the belt beforehand, will collect regional lung volume measurements using electrical impedance tomography (EIT). Subject video recording will capture apnea events and the interventions used to resolve them such as positive pressure ventilation, repositioning, or stimulation. Data will be collected for 15 minutes on nCPAP.
Respiratory support will be crossed over to a HFNC Optiflow Jr 2 (Fisher & Paykel Healthcare, Auckland, New Zealand) at a flow rate of 8 LPM. The size of the nasal cannula will be determined according to the manufacturer's instructions in order to maintain a leak at the nares. Identical data collection will occur for two 15 minute periods on HFNC, at the beginning and end of the six hour Study period.
After 6 hours of HFNC of 8 LPM, or sooner if the infant meets failure criteria, the infant will then be crossed back to the nCPAP device and at the settings previously utilized in Study Period 1. The infant will remain on the nCPAP device with identical data collection for 15 minutes. The total duration of the study and data collection will be 8 hours. The infant's body position will be similar for each lung volume measurement during the study periods.
Outcomes
Primary Outcome Measures
% Unventilated Lung
Atelectasis will be calculated using the percentage of the lung fields that are not engaged in tidal volume.(VT)
Secondary Outcome Measures
Geometric Center of Ventilation (CoV)
numeric value that describes the geographic point within the thorax that represents the statistical center of VT
End-expiratory lung volume
% of total VT within 8 lung regions, relative change in uncalibrated aeration
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03700606
Brief Title
Physiological Changes With High-Flow Nasal Cannula
Official Title
Physiological Changes With High-Flow Nasal Cannula Compared to Nasal CPAP in Extremely Low Birth Weight Infants
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
March 15, 2019 (Actual)
Primary Completion Date
December 20, 2021 (Actual)
Study Completion Date
February 14, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sharp HealthCare
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To measure changes in physiologic parameters in extremely low birthweight (ELBW) infants on high-flow nasal cannula compared to nasal continuous positive airway pressure (nCPAP).
Detailed Description
After informed consent is obtained, eligible infants who are stable on nCPAP therapy of 5-7 cm H20 achieved with a ventilator, an underwater "bubble" system, or a variable-flow device will be enrolled.
All subjects will have physiologic data and electrical impedance tomography collected at:
Baseline nCPAP for 15 minutes
Upon transition to high flow nasal cannula at 8 LPM for 6 hours. Data collection is obtained after infant is calm for 15 minutes at the beginning and end of this 6 hour period
Then upon return to baseline NCPAP for a final 15 minutes of data collection.
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
high flow nasal cannula, nasal cpap
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nasal CPAP - Period 1
Arm Type
Active Comparator
Arm Description
Eligible infants stable on high flow nasal cannula (nCPAP) therapy of 5-7 cm H20 achieved with a ventilator, an underwater "bubble" system, or a variable-flow device will be enrolled. A data acquisition cart will be placed at the subject's bedside to collect hemodynamic and respiratory parameters measured including: Heart rate (HR), blood pressure (BP), respiratory rate (RR), fraction of inspired oxygen (FiO2), transcutaneous carbon dioxide (TcCO2), and peripheral oxygen saturation (SpO2) via bedside monitoring devices. A neonatal chest belt, sized to the infant's chest circumference (nipple level) using warmed ultrasound gel applied to the belt beforehand, will collect regional lung volume measurements using electrical impedance tomography (EIT). Subject video recording will capture apnea events and the interventions used to resolve them such as positive pressure ventilation, repositioning, or stimulation. Data will be collected for 15 minutes on nCPAP.
Arm Title
High Flow Nasal Cannula (HFNC) - Period 2 & 3
Arm Type
Active Comparator
Arm Description
Respiratory support will be crossed over to a HFNC Optiflow Jr 2 (Fisher & Paykel Healthcare, Auckland, New Zealand) at a flow rate of 8 LPM. The size of the nasal cannula will be determined according to the manufacturer's instructions in order to maintain a leak at the nares. Identical data collection will occur for two 15 minute periods on HFNC, at the beginning and end of the six hour Study period.
Arm Title
Nasal CPAP - Period 4
Arm Type
Active Comparator
Arm Description
After 6 hours of HFNC of 8 LPM, or sooner if the infant meets failure criteria, the infant will then be crossed back to the nCPAP device and at the settings previously utilized in Study Period 1. The infant will remain on the nCPAP device with identical data collection for 15 minutes. The total duration of the study and data collection will be 8 hours. The infant's body position will be similar for each lung volume measurement during the study periods.
Intervention Type
Procedure
Intervention Name(s)
High flow nasal cannula
Intervention Description
8 liters per minute of blended oxygen through Fisher Paykel Optiflow Jr 2 nasal prongs.
Intervention Type
Procedure
Intervention Name(s)
Nasal CPAP
Intervention Description
Nasal continuous positive airway pressure of 5-7 cm/H20 delivered using Ventilator or bubble cpap device through short nasal prongs or a nasal face mask.
Primary Outcome Measure Information:
Title
% Unventilated Lung
Description
Atelectasis will be calculated using the percentage of the lung fields that are not engaged in tidal volume.(VT)
Time Frame
Through study completion, an average of 30 days
Secondary Outcome Measure Information:
Title
Geometric Center of Ventilation (CoV)
Description
numeric value that describes the geographic point within the thorax that represents the statistical center of VT
Time Frame
Through study completion, an average of 30 days
Title
End-expiratory lung volume
Description
% of total VT within 8 lung regions, relative change in uncalibrated aeration
Time Frame
Through study completion, an average of 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
23 Weeks
Maximum Age & Unit of Time
29 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
23 to 28+6 weeks gestational age at birth
Corrected gestational age less than or equal to 30 weeks
Over 72 hours of life
Stable on Nasal CPAP of 5-7cm H20
Hemodynamically stable
Tolerating routine handling
Nares size appropriate for Fisher & Paykel Optiflow Jr 2 HFNC size XS or small
Successfully extubated for 12 hours after administration of surfactant
Caffeine Citrate at a maintenance dose of 5 to 10 mg /kg
Transcutaneous monitoring in place
Stable blood gas (pH>/= 7.25 and PaCO2 <60 mmHg torr)
Exclusion Criteria:
Prior pneumothorax or evidence of pulmonary interstitial emphysema.
Prior or current pulmonary hemorrhage
Congenital airway malformations
Major cardiopulmonary malformations
Congenital Diaphragmatic hernia or untreated bowel obstruction
Poor respiratory drive unresponsive to CPAP therapy
Requirement of a nCPAP of >8 cmH20 or FiO2 > 0.3 to maintain oxygen saturations between 90-95 percent.
Receiving positive pressure breaths or SIPAP on prongs
Conflicting clinical trial
Clinically unstable per physician discretion
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anup Katheria, MD
Organizational Affiliation
Sharp HealthCare
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sharp Mary Birch Hospital for Women & Newborns
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
12. IPD Sharing Statement
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Physiological Changes With High-Flow Nasal Cannula
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