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NCT05030012 · ClinicalTrials.gov registry record · NA
Maintaining Optimal HVNI Delivery Using Automatic Titration of Oxygen in Preterm Infants
A NA study, sponsored by Vapotherm.
- Terminated
- Registry status
- NA
- Development phase
- 15
- Enrollment target
NCT05030012 is a NA study that was terminated before completion, run by Vapotherm. The registered enrollment target is 15 participants.
The verdict
NCT05030012, a NA study, was terminated before completion, sponsored by Vapotherm.
- TERMINATED
- Registry status
- NA
- Development phase
- 15 participants
- Enrollment target
Study 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.
Interventions
- DEVICE Automated Control
- DEVICE Manual Control
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2021-09-02 |
| Est. Completion | 2023-10-19 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05030012
The ClinicalTrials.gov registry entry for NCT05030012 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vapotherm, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Automated Control is the first listed.
NCT05030012 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05030012 about?
NCT05030012 is a clinical study titled "Maintaining Optimal HVNI Delivery Using Automatic Titration of Oxygen in Preterm Infants". 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 oxyg...
What is the current status of trial NCT05030012?
This trial is currently terminated. It is a NA study. The enrollment target is 15 participants. The study started on 2021-09-02. Estimated completion is 2023-10-19.
What interventions are being tested in trial NCT05030012?
The interventions under investigation include: Automated Control (DEVICE), Manual Control (DEVICE).
Who is sponsoring clinical trial NCT05030012?
This trial is sponsored by Vapotherm, which has 7 total clinical trials registered on ClinicalTrials.gov.
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