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Maintaining Optimal HVNI Delivery Using Automatic Titration of Oxygen in Preterm Infants
NA trial testing Automated Control in Infant, Premature in 15 participants. Terminated before completion.
| Lead sponsor | Vapotherm, Inc. |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 15 |
| Start date | 2 September 2021 |
| Primary completion | 19 October 2023 |
| Estimated completion | 19 October 2023 |
| Sites | 3 locations across United States |
Vapotherm, Inc.
Eligibility, any sex, with Infant, Premature or Neonatal Respiratory Distress. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of time spent outside target oxygen saturation range, measured by pulse oximetry (SpO2). A lower value indicates a better outcome.
| Group | Value | 95% CI |
|---|---|---|
| Automated Control (OAM) | 24.6 | ± 10.7 |
| Manual Control (Manual) | 45.1 | ± 11.4 |
Percentage of time spent within target oxygen saturation range, measured by pulse oximetry (SpO2). A higher value indicates a better outcome.
| Group | Value | 95% CI |
|---|---|---|
| Automated Control (OAM) | 73.6 | ± 10.7 |
| Manual Control (Manual) | 53.2 | ± 11.8 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Manual Control (Manual) | 52.2 | ± 11.6 |
| Automated Control (OAM) | 73.0 | ± 10.9 |
| Group | Value | 95% CI |
|---|---|---|
| Manual Control (Manual) | 67.4 | ± NA |
| Automated Control (OAM) | 81.3 | ± NA |
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.
| Group | Value | 95% CI |
|---|---|---|
| Manual Control (Manual) | 41.2 | ± 13.8 |
| Automated Control (OAM) | 75.7 | ± 19.6 |
| Group | Value | 95% CI |
|---|---|---|
| Manual Control (Manual) | 55.0 | ± 10.9 |
| Automated Control (OAM) | 73.3 | ± 10.1 |
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.
No peer-reviewed publications indexed yet for this trial.
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