Physiological Changes With High-Flow Nasal Cannula
- Conditions
- Respiratory Distress Syndrome in Premature Infant
- Registration Number
- NCT03700606
- Lead Sponsor
- Sharp HealthCare
- 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:
1. Baseline nCPAP for 15 minutes
2. 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
3. Then upon return to baseline NCPAP for a final 15 minutes of data collection.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method % Unventilated Lung Through study completion, an average of 30 days Atelectasis will be calculated using the percentage of the lung fields that are not engaged in tidal volume.(VT)
- Secondary Outcome Measures
Name Time Method Geometric Center of Ventilation (CoV) Through study completion, an average of 30 days numeric value that describes the geographic point within the thorax that represents the statistical center of VT
End-expiratory lung volume Through study completion, an average of 30 days % of total VT within 8 lung regions, relative change in uncalibrated aeration
Trial Locations
- Locations (1)
Sharp Mary Birch Hospital for Women & Newborns
🇺🇸San Diego, California, United States
Sharp Mary Birch Hospital for Women & Newborns🇺🇸San Diego, California, United States