Trial Outcomes & Findings for NICU Oxygen Control Study (NCT NCT04269161)
NCT ID: NCT04269161
Last Updated: 2025-07-04
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
48 participants
Primary outcome timeframe
Twenty-four study periods consisting of 6-hour manual study periods and 6-hour automatic study periods over six days for each of the subjects in the analysis.
Results posted on
2025-07-04
Participant Flow
Participant milestones
| Measure |
Crossover Sequence 1
In this arm, an automatic oxygen control device will be used to make adjustments to the blend of oxygen and air supplied to the subject for the first six hours.
In this arm, a nurse will manually make adjustments to the blend of oxygen and air supplied to the subject for the second six hours. The study continues in an automatic and manual repeating pattern for six days.
Automatic control of inspired oxygen: A device will be used to automatically adjust the blend of oxygen and air with the ability to return to manual control as needed.
|
Crossover Sequence 2
In this arm, a nurse will manually make adjustments to the blend of oxygen and air supplied to the subject as in the standard of care for the first six hours.
In this arm, an automatic oxygen control device will be used to make adjustments to the blend of oxygen and air supplied to the subject for the second six hours. The study continues in a manual and automatic repeating pattern for six days.
Automatic control of inspired oxygen: A device will be used to automatically adjust the blend of oxygen and air with the ability to return to manual control as needed.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
24
|
|
Overall Study
COMPLETED
|
19
|
20
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
Reasons for withdrawal
| Measure |
Crossover Sequence 1
In this arm, an automatic oxygen control device will be used to make adjustments to the blend of oxygen and air supplied to the subject for the first six hours.
In this arm, a nurse will manually make adjustments to the blend of oxygen and air supplied to the subject for the second six hours. The study continues in an automatic and manual repeating pattern for six days.
Automatic control of inspired oxygen: A device will be used to automatically adjust the blend of oxygen and air with the ability to return to manual control as needed.
|
Crossover Sequence 2
In this arm, a nurse will manually make adjustments to the blend of oxygen and air supplied to the subject as in the standard of care for the first six hours.
In this arm, an automatic oxygen control device will be used to make adjustments to the blend of oxygen and air supplied to the subject for the second six hours. The study continues in a manual and automatic repeating pattern for six days.
Automatic control of inspired oxygen: A device will be used to automatically adjust the blend of oxygen and air with the ability to return to manual control as needed.
|
|---|---|---|
|
Overall Study
Change of modality and no longer eligible
|
3
|
3
|
|
Overall Study
Required procedure outside of NICU
|
1
|
0
|
|
Overall Study
Equipment issue
|
1
|
1
|
Baseline Characteristics
NICU Oxygen Control Study
Baseline characteristics by cohort
| Measure |
Crossover Sequence 1 and 2, Automatic, Manual and Manual, Automatic
n=39 Participants
This group is comprised of Crossover Sequence 1 and Crossover Sequence 2 with all participants that completed six days in the study.
The automatic oxygen control device or the nurse made adjustments to the blend of oxygen and air supplied to the participant for alternating blocks of six hours.
The study continues in an automatic and manual repeating pattern for six days.
|
|---|---|
|
Age, Continuous
|
27.428 weeks
STANDARD_DEVIATION 2.448 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Crossover Sequence 1 or 2
Sequence 1 - Automatic, Manual
|
19 Participants
n=5 Participants
|
|
Crossover Sequence 1 or 2
Sequence 2 - Manual, Automatic
|
20 Participants
n=5 Participants
|
|
Modality
High-Flow Nasal Cannula (HFNC)
|
22 Participants
n=5 Participants
|
|
Modality
Bubble CPAP (BCPAP)
|
17 Participants
n=5 Participants
|
|
Weight at start of study
|
1702.205 grams
STANDARD_DEVIATION 531.817 • n=5 Participants
|
|
Bed type
Isolette
|
32 Participants
n=5 Participants
|
|
Bed type
Open Crib
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Twenty-four study periods consisting of 6-hour manual study periods and 6-hour automatic study periods over six days for each of the subjects in the analysis.Population: All participants that completed six days of the crossover study period were analyzed.
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.
Outcome measures
| Measure |
Manual Mode (Nurse)
n=39 Participants
Nurse adjusts the blend of oxygen and air manually for six hour periods (no automatic oxygen control by the device).
|
Automatic Mode (Device)
n=39 Participants
An investigational device used to automatically adjust the blend of oxygen and air for six-hour periods with the ability to return to manual control as needed.
|
|---|---|---|
|
Elapsed Time to Respond to SpO2 Alarm
|
51.408 seconds
Standard Deviation 66.168
|
41.523 seconds
Standard Deviation 30.771
|
SECONDARY outcome
Timeframe: Twelve 6-hour manual study periods and 6-hour automatic study periods over six days for each of the subjects in the analysis.Population: All participants who completed six days in the study were included in the analysis.
For each 6-hour time block, we calculate the proportion of time the patient stays within the prescribed SpO2 range. The proportion of time that the SpO2 is within the prescribed range is computed using an area-under-the-curve approach for data taken during automatic control by the experimental device and manual control by the nurse.
Outcome measures
| Measure |
Manual Mode (Nurse)
n=39 Participants
Nurse adjusts the blend of oxygen and air manually for six hour periods (no automatic oxygen control by the device).
|
Automatic Mode (Device)
n=39 Participants
An investigational device used to automatically adjust the blend of oxygen and air for six-hour periods with the ability to return to manual control as needed.
|
|---|---|---|
|
Proportion of Time SpO2 is Within the Prescribed Range in a Six-hour Time Block
|
0.676 proportion of time
Standard Deviation 0.214
|
0.695 proportion of time
Standard Deviation 0.224
|
Adverse Events
Manual Mode (Nurse)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Automatic Mode (Device)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place