Trial Outcomes & Findings for Maintaining Optimal HVNI Delivery Using Automatic Titration of Oxygen in Preterm Infants (NCT NCT05030012)
NCT ID: NCT05030012
Last Updated: 2024-06-26
Results Overview
Percentage of time spent outside target oxygen saturation range, measured by pulse oximetry (SpO2). A lower value indicates a better outcome.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
15 participants
Primary outcome timeframe
Through study completion, two consecutive 24-hour periods
Results posted on
2024-06-26
Participant Flow
Participant milestones
| Measure |
Automated Control (OAM) - Manual Control
The subject started on the Automated Control (OAM) arm. The subject was on this arm for 24 hours. After 24 hours, the subject switched to the Manual Control Arm. The subject was on this arm for 24 hours, for a total of 48 hours.
|
Manual Control - Automated Control (OAM)
The subject started on the Manual Control arm. The subject was on this arm for 24 hours. After 24 hours, the subject switched to the Automated Control (OAM) arm. The subject was on this arm for 24 hours, for a total of 48 hours.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
9
|
|
Overall Study
COMPLETED
|
6
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Maintaining Optimal HVNI Delivery Using Automatic Titration of Oxygen in Preterm Infants
Baseline characteristics by cohort
| Measure |
Automated Control (OAM) Then Manual Control
n=6 Participants
The subjects will start the study on the Automated Control (OAM) for a total of 24 hours. Then, the subjects will switch to the Manual Control Arm for 24 hours, for a total of 48 hours.
|
Manual Control (Manual) Then Automated Control (OAM)
n=9 Participants
The subjects will start the study on the Manual Control Arm for a total of 24 hours. Then, the subjects will switch to the Automated Control (OAM) Arm for 24 hours, for a total of 48 hours.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
6 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
27.5 Weeks
STANDARD_DEVIATION 2.8 • n=93 Participants
|
29.7 Weeks
STANDARD_DEVIATION 3.6 • n=4 Participants
|
28.8 Weeks
STANDARD_DEVIATION 3.4 • n=27 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=93 Participants
|
9 participants
n=4 Participants
|
15 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Through study completion, two consecutive 24-hour periodsPercentage of time spent outside target oxygen saturation range, measured by pulse oximetry (SpO2). A lower value indicates a better outcome.
Outcome measures
| Measure |
Automated Control (OAM)
n=15 Participants
Automated Control: The purpose of this intervention is to evaluate that the efficacy and safety during the automated performance of the Vapotherm OAM are not inferior to standard care practice (manual control) in maintaining SpO2 levels of 90-95% in preterm infants requiring oxygen adjustments while being treated with high velocity nasal insufflation (HVNI) therapy.
|
Manual Control (Manual)
n=15 Participants
Manual Control: The purpose of this intervention is to establish an active comparator via standard care practice against which to evaluate the efficacy and safety of the automated arm of the study, for determination of non-inferiority of that automated control arm to manual control in maintaining SpO2 levels of 90-95% in preterm infants being treated with high velocity nasal insufflation (HVNI) therapy.
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|---|---|---|
|
Primary Safety Objective - Percentage of Time Outside of SpO2 Target Range
|
24.6 percentage of time
Standard Deviation 10.7
|
45.1 percentage of time
Standard Deviation 11.4
|
PRIMARY outcome
Timeframe: Through study completion, two consecutive 24-hour periodsPercentage of time spent within target oxygen saturation range, measured by pulse oximetry (SpO2). A higher value indicates a better outcome.
Outcome measures
| Measure |
Automated Control (OAM)
n=15 Participants
Automated Control: The purpose of this intervention is to evaluate that the efficacy and safety during the automated performance of the Vapotherm OAM are not inferior to standard care practice (manual control) in maintaining SpO2 levels of 90-95% in preterm infants requiring oxygen adjustments while being treated with high velocity nasal insufflation (HVNI) therapy.
|
Manual Control (Manual)
n=15 Participants
Manual Control: The purpose of this intervention is to establish an active comparator via standard care practice against which to evaluate the efficacy and safety of the automated arm of the study, for determination of non-inferiority of that automated control arm to manual control in maintaining SpO2 levels of 90-95% in preterm infants being treated with high velocity nasal insufflation (HVNI) therapy.
|
|---|---|---|
|
Primary Performance Objective - Percentage of Time Within SpO2 Target Range
|
73.6 percentage of time
Standard Deviation 10.7
|
53.2 percentage of time
Standard Deviation 11.8
|
SECONDARY outcome
Timeframe: Through study completion, two consecutive 24-hour periodsPopulation: There are two weight categories, 14 were in the lower weight and 1 subject was in the higher weight.
Percentage of time spent within target oxygen saturation range across two weight groups (1000g-2500g, 2501g-3500g), measured by pulse oximetry (SpO2). A higher value indicates a better outcome.
Outcome measures
| Measure |
Automated Control (OAM)
n=15 Participants
Automated Control: The purpose of this intervention is to evaluate that the efficacy and safety during the automated performance of the Vapotherm OAM are not inferior to standard care practice (manual control) in maintaining SpO2 levels of 90-95% in preterm infants requiring oxygen adjustments while being treated with high velocity nasal insufflation (HVNI) therapy.
|
Manual Control (Manual)
n=15 Participants
Manual Control: The purpose of this intervention is to establish an active comparator via standard care practice against which to evaluate the efficacy and safety of the automated arm of the study, for determination of non-inferiority of that automated control arm to manual control in maintaining SpO2 levels of 90-95% in preterm infants being treated with high velocity nasal insufflation (HVNI) therapy.
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|---|---|---|
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Performance Endpoint, Percentage of Time IN Range (SpO2 in 90-95% With FiO2 Special at .21) Across the Two Weight Groups.
Lower Weight (1000g-2500g)
|
52.2 percentage of time
Standard Deviation 11.6
|
73.0 percentage of time
Standard Deviation 10.9
|
|
Performance Endpoint, Percentage of Time IN Range (SpO2 in 90-95% With FiO2 Special at .21) Across the Two Weight Groups.
Higher Weight (2501g - 3500g)
|
67.4 percentage of time
Standard Deviation NA
There is only one subject in this group - cannot get SD with one data set.
|
81.3 percentage of time
Standard Deviation NA
There is only one subject in this group - cannot get SD with one data set.
|
SECONDARY outcome
Timeframe: Through study completion, two consecutive 24-hour periodsPopulation: There are two skin pigment groups, dark and light. For the manual arm, there were two subjects in the dark and 13 in the light.
Percentage of time spent within target oxygen saturation range across two skin pigmentation groups (light, dark), measured by pulse oximetry (SpO2). A higher value indicates a better outcome.
Outcome measures
| Measure |
Automated Control (OAM)
n=15 Participants
Automated Control: The purpose of this intervention is to evaluate that the efficacy and safety during the automated performance of the Vapotherm OAM are not inferior to standard care practice (manual control) in maintaining SpO2 levels of 90-95% in preterm infants requiring oxygen adjustments while being treated with high velocity nasal insufflation (HVNI) therapy.
|
Manual Control (Manual)
n=15 Participants
Manual Control: The purpose of this intervention is to establish an active comparator via standard care practice against which to evaluate the efficacy and safety of the automated arm of the study, for determination of non-inferiority of that automated control arm to manual control in maintaining SpO2 levels of 90-95% in preterm infants being treated with high velocity nasal insufflation (HVNI) therapy.
|
|---|---|---|
|
Secondary Performance Objective 2 - Percentage of Time Within SpO2 Target Range (Skin Pigmentation)
Dark Skin
|
41.2 percentage of time
Standard Deviation 13.8
|
75.7 percentage of time
Standard Deviation 19.6
|
|
Secondary Performance Objective 2 - Percentage of Time Within SpO2 Target Range (Skin Pigmentation)
Light Skin
|
55.0 percentage of time
Standard Deviation 10.9
|
73.3 percentage of time
Standard Deviation 10.1
|
Adverse Events
Automated Control (OAM)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Manual Control (Manual)
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