N/A
N=48
NICU Oxygen Control Study
Hyperoxia · Hypoxia
Bottom Line
View on ClinicalTrials.gov: NCT04269161 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: Elapsed Time to Respond to SpO2 Alarm — 51.408; 41.523 seconds — p=0.003
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Automatic control of inspired oxygen (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- University of Missouri-Columbia
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Elapsed Time to Respond to SpO2 Alarm |
51.408; 41.523 | 0.003 sig |
| SECONDARY Proportion of Time SpO2 is Within the Prescribed Range in a Six-hour Time Block |
0.676; 0.695 | .02 sig |
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.
Eligibility Criteria
Inclusion Criteria
- Infants admitted to the NICU
- Less than 31 weeks estimated gestational age or less than 1500 grams at birth
- Currently on high flow nasal cannula or bubble CPAP
- Require at least 2 adjustments to the FiO2 per shift and/or have at least 2 desaturation events per shift
Exclusion Criteria
- Infants admitted to the NICU with congenital heart disease.
- Infants who are set on a minimum FiO2 set point by their healthcare provider
Data sourced from ClinicalTrials.gov (NCT04269161). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.