Bronchopulmonary Dysplasia Clinical Trial
— MODERATION NeoOfficial title:
Maintaining Optimal Delivery Using Automatic Titration of Oxygen in Preterm Infants Receiving High Velocity Nasal Insufflation Therapy
Verified date | October 2023 |
Source | Vapotherm, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 15 |
Est. completion date | October 19, 2023 |
Est. primary completion date | October 19, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: 1. 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 2. Patients that clinically require SpO2 maintenance within the target range of 90-95% 3. A need for supplemental oxygen as demonstrated by a required FiO2 > 0.25 at enrollment 4. 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). 5. A minimum of 6 manual FiO2 adjustments in the 24hr period prior to trial enrollment. 6. Willing/Able to complete informed consent. Exclusion Criteria: 1. Current patient weight of <1000g or >3500g at time of study 2. Major congenital abnormalities 3. Hemodynamic instability, defined as being outside of a normotensive range based on an infant's individual characteristics by clinician 4. Persistent unresolved apnea defined as: requiring 6 stimulations or more per 6 hours 5. Seizures 6. Ongoing sepsis 7. Meningitis 8. Clinician's concern regarding stability of the infant |
Country | Name | City | State |
---|---|---|---|
United States | University of Utah Hospital | Salt Lake City | Utah |
United States | Seattle Children's Hospital | Seattle | Washington |
United States | Children's National Hospital & Research Institute | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Vapotherm, Inc. | Children's National Research Institute, Seattle Children's Hospital, University of Utah |
United States,
Hagadorn JI, Furey AM, Nghiem TH, Schmid CH, Phelps DL, Pillers DA, Cole CH; AVIOx Study Group. Achieved versus intended pulse oximeter saturation in infants born less than 28 weeks' gestation: the AVIOx study. Pediatrics. 2006 Oct;118(4):1574-82. doi: 10.1542/peds.2005-0413. — View Citation
Reynolds PR, Miller TL, Volakis LI, Holland N, Dungan GC, Roehr CC, Ives K. Randomised cross-over study of automated oxygen control for preterm infants receiving nasal high flow. Arch Dis Child Fetal Neonatal Ed. 2019 Jul;104(4):F366-F371. doi: 10.1136/archdischild-2018-315342. Epub 2018 Nov 21. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primary Safety Objective - Proportion of Time Outside of SpO2 Target Range | Percentage of time spent outside target oxygen saturation range, measured by pulse oximetry (SpO2). A lower value indicates a better outcome. | Through study completion, two consecutive 24-hour periods | |
Primary | Primary Performance Objective - Proportion of Time Within SpO2 Target Range | Percentage of time spent within target oxygen saturation range, measured by pulse oximetry (SpO2). A higher value indicates a better outcome. | Through study completion, two consecutive 24-hour periods | |
Secondary | Secondary Performance Objective 1 - Proportion of Time Within SpO2 Target Range (Weight Groups) | Percentage of time spent within target oxygen saturation range across two weight groups (1000g-2500g, 2501g-3500g), measured by pulse oximetry (SpO2). A higher value indicates a better outcome. | Through study completion, two consecutive 24-hour periods | |
Secondary | Secondary Performance Objective 2 - Proportion of Time Within SpO2 Target Range (Skin Pigmentation) | Percentage of time spent within target oxygen saturation range across two skin pigmentation groups (light, dark), measured by pulse oximetry (SpO2). A higher value indicates a better outcome. | Through study completion, two consecutive 24-hour periods |
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