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NCT04269161 · ClinicalTrials.gov registry record · NA
NICU Oxygen Control Study
A NA study, sponsored by University of Missouri-Columbia.
- Completed
- Registry status
- NA
- Development phase
- 48
- Enrollment target
NCT04269161: Completed NA study, sponsored by University of Missouri-Columbia.
NCT04269161 is a NA study that has completed, run by University of Missouri-Columbia. The registered enrollment target is 48 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04269161, a NA study, has completed, sponsored by University of Missouri-Columbia.
- COMPLETED
- Registry status
- NA
- Development phase
- 48 participants
- Enrollment target
Study Summary
Prematurely born infants in the hospital neonatal intensive care unit (NICU) will be included in the study. This clinical trial is a randomized crossover study to show that our automated oxygen control device performance is no worse than a NICU nurse in keeping a premature neonate's SPO2 within the prescribed range. Since subjects receive the device (automatic oxygen control) and the standard of care (manual control by a nurse), every subject serves as their own perfectly matched control. Performance measures include the average time it takes for the SpO2 to return to the desired range (primary endpoint) and the total amount of time that the SpO2 is within the desired range (secondary endpoint). The device will be applied to premature infants on respiratory support humidified high flow nasal cannula (HFNC) with oxygen controlled using a blend valve. Two groups include one that begins the study period with the device and one that begins the study period without the device. The two groups are switched between manual and automatic every 6 hours into the trial period and complete a total of 6 days. The target number of subjects is 60. We will analyze the study as a superiority trial if there is strong evidence of superiority.
Primary Outcome
Mean in elapsed time needed to re- establish SpO2 within the desired range after an alarm. The alarms and alarm times are recorded directly from the bedside monitor and the responses are measured directly in terms of the blend valve position and SpO2 response measured by the pulse oximeter.
Interventions
- DEVICE Automatic control of inspired oxygen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2022-05-24 |
| Est. Completion | 2024-06-06 |
| Phase | NA |
What the finished NCT04269161 record still lists
NCT04269161 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Automatic control of inspired oxygen is the first listed.
NCT04269161 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04269161 about?
NCT04269161 is a clinical study titled "NICU Oxygen Control Study". Prematurely born infants in the hospital neonatal intensive care unit (NICU) will be included in the study. This clinical trial is a randomized crossover study to show that our automated oxygen control device performance is no worse than a NICU nurse in keeping a premature neonate's SPO2 within the ...
What is the current status of trial NCT04269161?
This trial is currently completed. It is a NA study. The enrollment target is 48 participants. The study started on 2022-05-24. Estimated completion is 2024-06-06.
What interventions are being tested in trial NCT04269161?
The interventions under investigation include: Automatic control of inspired oxygen (DEVICE).
Who is sponsoring clinical trial NCT04269161?
This trial is sponsored by University of Missouri-Columbia, which has 291 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04269161's enrollment target sits among peer trials
48 1381st of 2000 higher than 601 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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