Maintaining Optimal HVNI Delivery Using Automatic Titration of Oxygen in Preterm Infants (NCT05030012) | Clinical Trial Compass
TerminatedNot Applicable
Maintaining Optimal HVNI Delivery Using Automatic Titration of Oxygen in Preterm Infants
Stopped: No path to obtain FDA approval for the legacy Precision Flow OAM.
United States15 participantsStarted 2021-09-02
Plain-language summary
Oxygen treatment is common in management of preterm babies requiring intensive care. Delivery of too much or too little oxygen increase the risk of damage to eyes and lungs, and contributes to death and disability. Oxygen control in preterm infants requires frequent adjustments in the amount of oxygen delivered to the baby. This is generally performed manually by a clinician attending the baby, and generally directed to maintaining a specific range of blood oxygen saturation. The manual control often results in only half of the time in the specified range, with the baby experiencing high and low blood oxygen saturations.
The technology being studied is designed to assist the clinician in maintaining blood oxygen saturation within target range by measuring oxygen saturation and automatically adjusting the amount of oxygen delivered for babies receiving high velocity nasal insufflation (an advanced form of high flow oxygen therapy). The proposed study will evaluate the efficacy and safety of the automatic control of oxygen by the new technology, as compared to manual control, among babies receiving high velocity therapy in a neonatal intensive care unit.
Who can participate
SexALL
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Inclusion criteria
✓. Infants delivered at a gestational age of less than or equal to 35 6/7 weeks (Preterm) being treated with high velocity nasal insufflation therapy for the management of respiratory distress syndrome
✓. Patients that clinically require SpO2 maintenance within the target range of 90-95%
✓. A need for supplemental oxygen as demonstrated by a required FiO2 \> 0.25 at enrollment
✓. Requiring a flow rate of greater than 2 L•min-1 such that the assumed inspired oxygen fraction matched delivered oxygen fraction (definition of HVNI).
✓. A minimum of 6 manual FiO2 adjustments in the 24hr period prior to trial enrollment.
✓. Willing/Able to complete informed consent.
Exclusion criteria
✕. Current patient weight of \<1000g or \>3500g at time of study
✕. Major congenital abnormalities
✕. Hemodynamic instability, defined as being outside of a normotensive range based on an infant's individual characteristics by clinician
✕. Persistent unresolved apnea defined as: requiring 6 stimulations or more per 6 hours
What they're measuring
1
Primary Safety Objective - Percentage of Time Outside of SpO2 Target Range
Timeframe: Through study completion, two consecutive 24-hour periods
2
Primary Performance Objective - Percentage of Time Within SpO2 Target Range
Timeframe: Through study completion, two consecutive 24-hour periods