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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 is a NA study that has completed, run by University of Missouri-Columbia. The registered enrollment target is 48 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04269161
The ClinicalTrials.gov registry entry for NCT04269161 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Missouri-Columbia, which has 291 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Automatic control of inspired oxygen is the first listed.
NCT04269161 reports 0 study locations.
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.
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