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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: Clinical Trial NA study, sponsored by Vapotherm.
NCT05030012 is a NA study that was terminated before completion, run by Vapotherm. The registered enrollment target is 15 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Percentage of time spent outside target oxygen saturation range, measured by pulse oximetry (SpO2). A lower value indicates a better outcome.
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 |
Why NCT05030012 stopped before completion
NCT05030012 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Automated Control is the first listed.
NCT05030012 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05030012's enrollment target sits among peer trials
15 1881st of 2000 higher than 92 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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