Trial Outcomes & Findings for Comparison of High Flow Nasal Cannula and Standard Face Mask Oxygen Therapy in Children With Bronchiolitis (NCT NCT04245202)
NCT ID: NCT04245202
Last Updated: 2021-02-16
Results Overview
The time that heart rate takes into the normal range for age between the groups (Per-protocol analysis).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
87 participants
Primary outcome timeframe
through study completion, an average of 96 hours
Results posted on
2021-02-16
Participant Flow
From March 14, 2017, through March 10, 2020, 5643 patients were presented to the emergency department and pediatric pulmonology unit of Ege University Medical Faculty. Four hundred seventy-two children were eligible for the study, with 134 missing opportunities to enroll, and 251 parents declined consent. We randomly assigned 87 children to Standard face mask oxygen therapy and High-Flow nasal cannula therapy.
No patients were excluded from the study after participant enrollment.
Participant milestones
| Measure |
St-FMOT
Children in the standard-therapy group received supplemental oxygen via a simple face mask, a range of 6-10 L/min, to maintain oxygen saturation level between 92-98%. Those who sustained the oxygen saturation \>92% in the ambient oxygen concentration were weaned off Standard face mask oxygen therapy.
|
HFNCOT
Children in the high-flow group received heated and humidified high-flow oxygen at a rate of 2 L\*kg/min (maximum 25 L/min), using an age-appropriate Optiflow Junior cannula and Airvo 2 high-flow system (Fisher and Paykel Healthcare). The initial fraction of inspired oxygen (FiO2) was set at 40%. The starting flow rate continued for a minimum of 4 hours. According to the patients' clinical response, the flow rate was decreased by 0.5 L\*kg/min per hour. The FiO2 was adjusted to obtain the oxygen saturation levels between 92-98%. When the flow rate was at 0.5 L\*kg/min, and the FiO2 was equal to the ambient oxygen concentration, High-Flow nasal cannula oxygen therapy was stopped.
|
|---|---|---|
|
Overall Study
STARTED
|
48
|
39
|
|
Overall Study
COMPLETED
|
38
|
38
|
|
Overall Study
NOT COMPLETED
|
10
|
1
|
Reasons for withdrawal
| Measure |
St-FMOT
Children in the standard-therapy group received supplemental oxygen via a simple face mask, a range of 6-10 L/min, to maintain oxygen saturation level between 92-98%. Those who sustained the oxygen saturation \>92% in the ambient oxygen concentration were weaned off Standard face mask oxygen therapy.
|
HFNCOT
Children in the high-flow group received heated and humidified high-flow oxygen at a rate of 2 L\*kg/min (maximum 25 L/min), using an age-appropriate Optiflow Junior cannula and Airvo 2 high-flow system (Fisher and Paykel Healthcare). The initial fraction of inspired oxygen (FiO2) was set at 40%. The starting flow rate continued for a minimum of 4 hours. According to the patients' clinical response, the flow rate was decreased by 0.5 L\*kg/min per hour. The FiO2 was adjusted to obtain the oxygen saturation levels between 92-98%. When the flow rate was at 0.5 L\*kg/min, and the FiO2 was equal to the ambient oxygen concentration, High-Flow nasal cannula oxygen therapy was stopped.
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
10
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
St-FMOT
n=48 Participants
Children who received standard face mask oxygen treatment
|
HFNCOT
n=39 Participants
Children who received high flow nasal cannula oxygen treatment
|
Total
n=87 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
6.5 months
n=48 Participants
|
6.0 months
n=39 Participants
|
6.0 months
n=87 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=48 Participants
|
15 Participants
n=39 Participants
|
36 Participants
n=87 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=48 Participants
|
24 Participants
n=39 Participants
|
51 Participants
n=87 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Turkey
|
48 participants
n=48 Participants
|
39 participants
n=39 Participants
|
87 participants
n=87 Participants
|
|
Gestational age at birth
Prematurity (< 37 weeks)
|
7 Participants
n=48 Participants
|
8 Participants
n=39 Participants
|
15 Participants
n=87 Participants
|
|
Gestational age at birth
Term infant (> 36 weeks)
|
41 Participants
n=48 Participants
|
31 Participants
n=39 Participants
|
72 Participants
n=87 Participants
|
|
Weight at the admission (kg)
|
7.4 kilogram
n=48 Participants
|
8.0 kilogram
n=39 Participants
|
8.0 kilogram
n=87 Participants
|
|
Baseline heart rate
|
174.0 beat per minute
n=48 Participants
|
170.0 beat per minute
n=39 Participants
|
173.0 beat per minute
n=87 Participants
|
|
Baseline respiratory rate
|
64.5 Breaths per minute
n=48 Participants
|
66.0 Breaths per minute
n=39 Participants
|
66.0 Breaths per minute
n=87 Participants
|
|
Baseline Oxygen Saturation
|
88.0 percentage of saturated oxygen
n=48 Participants
|
87.0 percentage of saturated oxygen
n=39 Participants
|
88.0 percentage of saturated oxygen
n=87 Participants
|
|
Baseline clinical respiratory score
|
9.0 score on a scale
n=48 Participants
|
9.5 score on a scale
n=39 Participants
|
9.0 score on a scale
n=87 Participants
|
|
Severity of clinical respiratory score
Moderate
|
18 Participants
n=48 Participants
|
9 Participants
n=39 Participants
|
27 Participants
n=87 Participants
|
|
Severity of clinical respiratory score
Severe
|
30 Participants
n=48 Participants
|
30 Participants
n=39 Participants
|
60 Participants
n=87 Participants
|
|
Season admitted
Winter
|
28 Participants
n=48 Participants
|
25 Participants
n=39 Participants
|
53 Participants
n=87 Participants
|
|
Season admitted
Autumn
|
9 Participants
n=48 Participants
|
7 Participants
n=39 Participants
|
16 Participants
n=87 Participants
|
|
Season admitted
Spring
|
7 Participants
n=48 Participants
|
4 Participants
n=39 Participants
|
11 Participants
n=87 Participants
|
|
Season admitted
Summer
|
4 Participants
n=48 Participants
|
3 Participants
n=39 Participants
|
7 Participants
n=87 Participants
|
|
Number of detected virus
No virus
|
2 Participants
n=48 Participants
|
0 Participants
n=39 Participants
|
2 Participants
n=87 Participants
|
|
Number of detected virus
1 virus
|
39 Participants
n=48 Participants
|
32 Participants
n=39 Participants
|
71 Participants
n=87 Participants
|
|
Number of detected virus
2 viruses
|
7 Participants
n=48 Participants
|
7 Participants
n=39 Participants
|
14 Participants
n=87 Participants
|
|
Virus detected
RSV
|
19 Participants
n=48 Participants
|
21 Participants
n=39 Participants
|
40 Participants
n=87 Participants
|
|
Virus detected
HRV
|
7 Participants
n=48 Participants
|
4 Participants
n=39 Participants
|
11 Participants
n=87 Participants
|
|
Virus detected
FLUA
|
2 Participants
n=48 Participants
|
1 Participants
n=39 Participants
|
3 Participants
n=87 Participants
|
|
Virus detected
PIV3
|
1 Participants
n=48 Participants
|
1 Participants
n=39 Participants
|
2 Participants
n=87 Participants
|
|
Virus detected
HBoV
|
4 Participants
n=48 Participants
|
3 Participants
n=39 Participants
|
7 Participants
n=87 Participants
|
|
Virus detected
hMPV
|
4 Participants
n=48 Participants
|
2 Participants
n=39 Participants
|
6 Participants
n=87 Participants
|
|
Virus detected
hCoV
|
0 Participants
n=48 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=87 Participants
|
|
Virus detected
RSV+HRV
|
0 Participants
n=48 Participants
|
2 Participants
n=39 Participants
|
2 Participants
n=87 Participants
|
|
Virus detected
RSV+PIV2
|
1 Participants
n=48 Participants
|
1 Participants
n=39 Participants
|
2 Participants
n=87 Participants
|
|
Virus detected
RSV+PIV3
|
1 Participants
n=48 Participants
|
1 Participants
n=39 Participants
|
2 Participants
n=87 Participants
|
|
Virus detected
RSV+FLUA
|
2 Participants
n=48 Participants
|
0 Participants
n=39 Participants
|
2 Participants
n=87 Participants
|
|
Virus detected
RSV+hCOV
|
1 Participants
n=48 Participants
|
0 Participants
n=39 Participants
|
1 Participants
n=87 Participants
|
|
Virus detected
HBoV+hCOV
|
0 Participants
n=48 Participants
|
1 Participants
n=39 Participants
|
1 Participants
n=87 Participants
|
|
Virus detected
hMPV+hCOV
|
1 Participants
n=48 Participants
|
0 Participants
n=39 Participants
|
1 Participants
n=87 Participants
|
|
Virus detected
hCOV+hAV
|
1 Participants
n=48 Participants
|
1 Participants
n=39 Participants
|
2 Participants
n=87 Participants
|
|
Virus detected
RSV+HBoV
|
1 Participants
n=48 Participants
|
0 Participants
n=39 Participants
|
1 Participants
n=87 Participants
|
|
Virus detected
HRV+FLUA
|
0 Participants
n=48 Participants
|
1 Participants
n=39 Participants
|
1 Participants
n=87 Participants
|
|
Virus detected
HRV+HBoV
|
1 Participants
n=48 Participants
|
0 Participants
n=39 Participants
|
1 Participants
n=87 Participants
|
|
Virus detected
No virus
|
2 Participants
n=48 Participants
|
0 Participants
n=39 Participants
|
2 Participants
n=87 Participants
|
PRIMARY outcome
Timeframe: through study completion, an average of 96 hoursPopulation: The population of the per-protocol.
The time that heart rate takes into the normal range for age between the groups (Per-protocol analysis).
Outcome measures
| Measure |
St-FMOT
n=38 Participants
Children who received Standard Face Mask Oxygen Therapy
|
HFNCOT
n=38 Participants
Children who received High-Flow Nasal Cannula Oxygen Therapy
|
|---|---|---|
|
Time Taken to Reach the Normal Range for Heart Rate (Per-protocol Analysis)
|
12 hour
Interval 2.0 to 24.0
|
2 hour
Interval 1.0 to 4.0
|
PRIMARY outcome
Timeframe: through study completion, an average of 96 hoursPopulation: The population of the per-protocol.
The time that the respiratory rate takes into the normal range for age between the groups (Per-protocol analysis).
Outcome measures
| Measure |
St-FMOT
n=38 Participants
Children who received Standard Face Mask Oxygen Therapy
|
HFNCOT
n=38 Participants
Children who received High-Flow Nasal Cannula Oxygen Therapy
|
|---|---|---|
|
Time Taken to Reach the Normal Range for Respiratory Rate (Per-protocol Analysis)
|
24 hour
Interval 4.0 to 48.0
|
4 hour
Interval 2.0 to 12.0
|
PRIMARY outcome
Timeframe: through study completion, an average of 96 hoursPopulation: The population of the per-protocol.
Unabbreviated scale title: Clinical Respiratory Score (Per-protocol analysis). The time that takes from severe bronchiolitis (9-12 points) to moderate bronchiolitis (5-8 points) or from moderate bronchiolitis (5-8 points) to mild bronchiolitis (0-4 points) between the groups. Higher scores mean a worse outcome. The score ranges from 0-12.
Outcome measures
| Measure |
St-FMOT
n=38 Participants
Children who received Standard Face Mask Oxygen Therapy
|
HFNCOT
n=38 Participants
Children who received High-Flow Nasal Cannula Oxygen Therapy
|
|---|---|---|
|
Time Taken to Regress A Lower Clinical Respiratory Score (Per-protocol Analysis)
|
4 hour
Interval 2.0 to 24.0
|
2 hour
Interval 1.0 to 4.0
|
SECONDARY outcome
Timeframe: Baseline, 1,2,4,12,24,48,72 and 96 hoursPopulation: Intention to treat analysis
Any differences in the time any recorded changes in heart rate from randomization to the patients' discharge within the groups and between the groups (Intention-to-treat analysis).
Outcome measures
| Measure |
St-FMOT
n=48 Participants
Children who received Standard Face Mask Oxygen Therapy
|
HFNCOT
n=39 Participants
Children who received High-Flow Nasal Cannula Oxygen Therapy
|
|---|---|---|
|
Heart Rate (Intention-to-treat Analysis)
Baseline
|
172.90 beats per minute
Interval 167.68 to 178.64
|
171.05 beats per minute
Interval 165.26 to 176.84
|
|
Heart Rate (Intention-to-treat Analysis)
1 hour
|
166.21 beats per minute
Interval 160.99 to 171.43
|
151.28 beats per minute
Interval 145.49 to 157.07
|
|
Heart Rate (Intention-to-treat Analysis)
2 hours
|
164.00 beats per minute
Interval 158.78 to 169.22
|
146.59 beats per minute
Interval 140.8 to 152.38
|
|
Heart Rate (Intention-to-treat Analysis)
4 hours
|
159.65 beats per minute
Interval 154.43 to 164.86
|
138.05 beats per minute
Interval 132.26 to 143.84
|
|
Heart Rate (Intention-to-treat Analysis)
12 hours
|
153.43 beats per minute
Interval 147.88 to 158.98
|
132.47 beats per minute
Interval 126.64 to 138.29
|
|
Heart Rate (Intention-to-treat Analysis)
24 hours
|
142.96 beats per minute
Interval 137.25 to 148.67
|
132.56 beats per minute
Interval 126.71 to 138.4
|
|
Heart Rate (Intention-to-treat Analysis)
48 hours
|
139.21 beats per minute
Interval 133.42 to 145.0
|
128.48 beats per minute
Interval 122.63 to 134.34
|
|
Heart Rate (Intention-to-treat Analysis)
72 hours
|
135.99 beats per minute
Interval 130.09 to 141.9
|
124.96 beats per minute
Interval 118.92 to 130.99
|
|
Heart Rate (Intention-to-treat Analysis)
96 hours
|
133.61 beats per minute
Interval 127.6 to 139.62
|
119.47 beats per minute
Interval 113.15 to 125.8
|
SECONDARY outcome
Timeframe: Baseline, 1,2,4,12,24,48,72 and 96 hoursPopulation: Per-protocol analysis
Any differences in the time any recorded changes in heart rate from randomization to the patients' discharge within the groups and between the groups (Per-protocol analysis).
Outcome measures
| Measure |
St-FMOT
n=38 Participants
Children who received Standard Face Mask Oxygen Therapy
|
HFNCOT
n=38 Participants
Children who received High-Flow Nasal Cannula Oxygen Therapy
|
|---|---|---|
|
Heart Rate (Per-protocol Analysis)
Baseline
|
169.03 beats per minute
Interval 164.22 to 173.83
|
170.37 beats per minute
Interval 165.56 to 175.17
|
|
Heart Rate (Per-protocol Analysis)
1 hour
|
160.76 beats per minute
Interval 155.96 to 165.57
|
150.37 beats per minute
Interval 145.56 to 155.17
|
|
Heart Rate (Per-protocol Analysis)
2 hours
|
157.58 beats per minute
Interval 152.77 to 162.38
|
145.39 beats per minute
Interval 140.59 to 150.2
|
|
Heart Rate (Per-protocol Analysis)
4 hours
|
150.66 beats per minute
Interval 145.85 to 155.46
|
136.42 beats per minute
Interval 131.62 to 141.23
|
|
Heart Rate (Per-protocol Analysis)
12 hours
|
147.08 beats per minute
Interval 142.27 to 151.88
|
131.32 beats per minute
Interval 126.51 to 136.54
|
|
Heart Rate (Per-protocol Analysis)
24 hours
|
138.45 beats per minute
Interval 133.64 to 143.25
|
131.74 beats per minute
Interval 126.93 to 136.54
|
|
Heart Rate (Per-protocol Analysis)
48 hours
|
135.97 beats per minute
Interval 131.17 to 140.78
|
127.89 beats per minute
Interval 123.09 to 132.7
|
|
Heart Rate (Per-protocol Analysis)
72 hours
|
136.43 beats per minute
Interval 131.54 to 141.31
|
124.57 beats per minute
Interval 119.6 to 129.54
|
|
Heart Rate (Per-protocol Analysis)
96 hours
|
133.85 beats per minute
Interval 128.9 to 138.81
|
122.53 beats per minute
Interval 117.3 to 127.76
|
SECONDARY outcome
Timeframe: Baseline, 1,2,4,12,24,48,72 and 96 hoursPopulation: Intention to treat analysis.
Any differences in the time any recorded changes in respiratory rate from randomization to the patients' discharge within the groups and between the groups (Intention-to-treat analysis).
Outcome measures
| Measure |
St-FMOT
n=48 Participants
Children who received Standard Face Mask Oxygen Therapy
|
HFNCOT
n=39 Participants
Children who received High-Flow Nasal Cannula Oxygen Therapy
|
|---|---|---|
|
Respiratory Rate (Intention-to-treat Analysis)
Baseline
|
65.08 Breaths per minute
Interval 62.77 to 67.39
|
66.71 Breaths per minute
Interval 64.15 to 69.27
|
|
Respiratory Rate (Intention-to-treat Analysis)
1 hour
|
60.20 Breaths per minute
Interval 57.89 to 62.51
|
56.84 Breaths per minute
Interval 54.28 to 59.4
|
|
Respiratory Rate (Intention-to-treat Analysis)
2 hours
|
57.45 Breaths per minute
Interval 55.14 to 59.76
|
51.10 Breaths per minute
Interval 48.54 to 53.66
|
|
Respiratory Rate (Intention-to-treat Analysis)
4 hours
|
55.54 Breaths per minute
Interval 53.23 to 57.85
|
46.56 Breaths per minute
Interval 44.0 to 49.12
|
|
Respiratory Rate (Intention-to-treat Analysis)
12 hours
|
51.06 Breaths per minute
Interval 48.63 to 53.48
|
44.15 Breaths per minute
Interval 41.57 to 46.72
|
|
Respiratory Rate (Intention-to-treat Analysis)
24 hours
|
46.54 Breaths per minute
Interval 44.05 to 49.03
|
40.82 Breaths per minute
Interval 38.24 to 43.4
|
|
Respiratory Rate (Intention-to-treat Analysis)
48 hours
|
41.89 Breaths per minute
Interval 39.36 to 44.42
|
39.32 Breaths per minute
Interval 36.74 to 41.91
|
|
Respiratory Rate (Intention-to-treat Analysis)
72 hours
|
39.24 Breaths per minute
Interval 36.65 to 41.82
|
36.70 Breaths per minute
Interval 34.07 to 39.34
|
|
Respiratory Rate (Intention-to-treat Analysis)
96 hours
|
37.75 Breaths per minute
Interval 35.12 to 40.38
|
35.47 Breaths per minute
Interval 32.79 to 38.22
|
SECONDARY outcome
Timeframe: Baseline, 1,2,4,12,24,48,72 and 96 hoursPopulation: Per-protocol analysis.
Any differences in the time any recorded changes in respiratory rate from randomization to the patients' discharge within the groups and between the groups (Per-protocol analysis).
Outcome measures
| Measure |
St-FMOT
n=38 Participants
Children who received Standard Face Mask Oxygen Therapy
|
HFNCOT
n=38 Participants
Children who received High-Flow Nasal Cannula Oxygen Therapy
|
|---|---|---|
|
Respiratory Rate (Per-protocol Analysis)
24 hours
|
44.23 breaths per minute
Interval 41.86 to 46.6
|
40.47 breaths per minute
Interval 38.1 to 42.84
|
|
Respiratory Rate (Per-protocol Analysis)
Baseline
|
65.52 breaths per minute
Interval 63.15 to 67.89
|
66.68 breaths per minute
Interval 64.31 to 69.05
|
|
Respiratory Rate (Per-protocol Analysis)
1 hour
|
59.50 breaths per minute
Interval 57.12 to 61.87
|
56.60 breaths per minute
Interval 54.23 to 58.97
|
|
Respiratory Rate (Per-protocol Analysis)
2 hours
|
55.34 breaths per minute
Interval 52.96 to 57.71
|
50.65 breaths per minute
Interval 48.28 to 53.03
|
|
Respiratory Rate (Per-protocol Analysis)
4 hours
|
51.81 breaths per minute
Interval 49.44 to 54.18
|
46.00 breaths per minute
Interval 43.62 to 48.37
|
|
Respiratory Rate (Per-protocol Analysis)
12 hours
|
48.13 breaths per minute
Interval 45.75 to 50.5
|
43.71 breaths per minute
Interval 41.33 to 46.08
|
|
Respiratory Rate (Per-protocol Analysis)
48 hours
|
40.07 breaths per minute
Interval 37.7 to 42.45
|
39.05 breaths per minute
Interval 36.68 to 41.42
|
|
Respiratory Rate (Per-protocol Analysis)
72 hours
|
37.82 breaths per minute
Interval 35.42 to 40.22
|
36.51 breaths per minute
Interval 34.09 to 38.92
|
|
Respiratory Rate (Per-protocol Analysis)
96 hours
|
36.63 breaths per minute
Interval 34.2 to 39.06
|
35.37 breaths per minute
Interval 32.85 to 37.89
|
SECONDARY outcome
Timeframe: Baseline, 1,2,4,12,24,48,72 and 96 hoursPopulation: Intention to treat analysis.
Unabbreviated scale title: Clinical Respiratory Score (Intention-to-treat analysis) Any differences in the time any recorded changes in the clinical respiratory score from randomization to the patients' discharge within the groups and between the groups. This clinical respiratory score includes respiratory rate, retraction, dyspnea/consciousness status, and wheezing. The severity of parameters is scored 0 to 3 points, and the patients with a clinical respiratory score of 0-4 points were defined as mild, moderate (5-8 points), and severe (9-12 point) bronchiolitis. Higher scores mean a worse outcome. The score ranges from 0-12.
Outcome measures
| Measure |
St-FMOT
n=48 Participants
Children who received Standard Face Mask Oxygen Therapy
|
HFNCOT
n=39 Participants
Children who received High-Flow Nasal Cannula Oxygen Therapy
|
|---|---|---|
|
Clinical Respiratory Score (Intention-to-treat Analysis)
Baseline
|
9.0 score on a scale
Interval 7.0 to 10.0
|
10.0 score on a scale
Interval 9.0 to 11.0
|
|
Clinical Respiratory Score (Intention-to-treat Analysis)
1 hour
|
8.0 score on a scale
Interval 6.5 to 10.0
|
7.0 score on a scale
Interval 7.0 to 9.0
|
|
Clinical Respiratory Score (Intention-to-treat Analysis)
2 hours
|
8.0 score on a scale
Interval 6.0 to 10.0
|
6.0 score on a scale
Interval 5.0 to 8.0
|
|
Clinical Respiratory Score (Intention-to-treat Analysis)
4 hours
|
7.0 score on a scale
Interval 6.0 to 9.5
|
5.0 score on a scale
Interval 4.0 to 7.0
|
|
Clinical Respiratory Score (Intention-to-treat Analysis)
12 hours
|
5.0 score on a scale
Interval 4.0 to 7.0
|
5.0 score on a scale
Interval 3.0 to 6.0
|
|
Clinical Respiratory Score (Intention-to-treat Analysis)
24 hours
|
4.5 score on a scale
Interval 3.0 to 6.0
|
4.0 score on a scale
Interval 2.0 to 5.0
|
|
Clinical Respiratory Score (Intention-to-treat Analysis)
48 hours
|
3.5 score on a scale
Interval 2.0 to 5.0
|
2.0 score on a scale
Interval 1.0 to 4.0
|
|
Clinical Respiratory Score (Intention-to-treat Analysis)
72 hours
|
2.0 score on a scale
Interval 1.0 to 4.0
|
2.0 score on a scale
Interval 1.0 to 3.0
|
|
Clinical Respiratory Score (Intention-to-treat Analysis)
96 hours
|
1.0 score on a scale
Interval 0.0 to 3.0
|
1.0 score on a scale
Interval 0.0 to 2.0
|
SECONDARY outcome
Timeframe: Baseline, 1,2,4,12,24,48,72 and 96 hoursPopulation: Per-protocol analysis.
Unabbreviated scale title: Clinical Respiratory Score (Per-protocol analysis). Any differences in the time any recorded changes in the clinical respiratory score from randomization to the patients' discharge within the groups and between the groups. This clinical respiratory score includes respiratory rate, retraction, dyspnea/consciousness status, and wheezing. The severity of parameters is scored 0 to 3 points, and the patients with a clinical respiratory score of 0-4 points were defined as mild, moderate (5-8 points), and severe (9-12 point) bronchiolitis. Higher scores mean a worse outcome. The score ranges from 0-12.
Outcome measures
| Measure |
St-FMOT
n=38 Participants
Children who received Standard Face Mask Oxygen Therapy
|
HFNCOT
n=38 Participants
Children who received High-Flow Nasal Cannula Oxygen Therapy
|
|---|---|---|
|
Clinical Respiratory Score (Per-protocol Analysis)
Baseline
|
9.0 score on a scale
Interval 7.0 to 10.2
|
9.5 score on a scale
Interval 8.7 to 11.0
|
|
Clinical Respiratory Score (Per-protocol Analysis)
1 hour
|
8.0 score on a scale
Interval 6.0 to 9.0
|
7.0 score on a scale
Interval 7.0 to 9.0
|
|
Clinical Respiratory Score (Per-protocol Analysis)
2 hours
|
7.0 score on a scale
Interval 5.7 to 8.0
|
6.0 score on a scale
Interval 5.0 to 8.0
|
|
Clinical Respiratory Score (Per-protocol Analysis)
4 hours
|
6.0 score on a scale
Interval 5.0 to 8.0
|
5.0 score on a scale
Interval 4.0 to 6.2
|
|
Clinical Respiratory Score (Per-protocol Analysis)
12 hours
|
5.0 score on a scale
Interval 4.0 to 7.0
|
5.0 score on a scale
Interval 3.0 to 6.0
|
|
Clinical Respiratory Score (Per-protocol Analysis)
24 hours
|
4.5 score on a scale
Interval 2.7 to 6.0
|
4.0 score on a scale
Interval 2.0 to 5.0
|
|
Clinical Respiratory Score (Per-protocol Analysis)
48 hours
|
3.5 score on a scale
Interval 2.0 to 5.0
|
2.0 score on a scale
Interval 1.0 to 4.0
|
|
Clinical Respiratory Score (Per-protocol Analysis)
72 hours
|
2.0 score on a scale
Interval 1.0 to 4.0
|
2.0 score on a scale
Interval 1.0 to 3.0
|
|
Clinical Respiratory Score (Per-protocol Analysis)
96 hours
|
1.0 score on a scale
Interval 0.0 to 3.0
|
1.0 score on a scale
Interval 0.0 to 2.0
|
SECONDARY outcome
Timeframe: through study completion, an average of 168 hoursPopulation: Intention to treat analysis
The total duration of oxygen therapy (Intention-to-treat analysis).
Outcome measures
| Measure |
St-FMOT
n=48 Participants
Children who received Standard Face Mask Oxygen Therapy
|
HFNCOT
n=39 Participants
Children who received High-Flow Nasal Cannula Oxygen Therapy
|
|---|---|---|
|
Oxygen Requirement (Intention-to-treat Analysis)
|
29.5 hour
Interval 14.0 to 45.7
|
19.0 hour
Interval 4.0 to 30.0
|
SECONDARY outcome
Timeframe: through study completion, an average of 168 hoursPopulation: Per-protocol analysis.
The total duration of oxygen therapy (Per-protocol analysis).
Outcome measures
| Measure |
St-FMOT
n=38 Participants
Children who received Standard Face Mask Oxygen Therapy
|
HFNCOT
n=38 Participants
Children who received High-Flow Nasal Cannula Oxygen Therapy
|
|---|---|---|
|
Oxygen Requirement (Per-protocol Analysis)
|
24.0 hour
Interval 12.0 to 38.5
|
18.5 hour
Interval 4.0 to 30.0
|
SECONDARY outcome
Timeframe: through study completion, an average of 168 hoursPopulation: Intention to treat analysis.
The time from randomization to the patient's discharge (Intention-to-treat analysis).
Outcome measures
| Measure |
St-FMOT
n=48 Participants
Children who received Standard Face Mask Oxygen Therapy
|
HFNCOT
n=39 Participants
Children who received High-Flow Nasal Cannula Oxygen Therapy
|
|---|---|---|
|
Length of Hospital Stay (Intention-to-treat Analysis)
|
5.5 day
Interval 4.0 to 7.7
|
5.0 day
Interval 4.0 to 7.0
|
SECONDARY outcome
Timeframe: through study completion, an average of 168 hoursPopulation: Per-protocol analysis
The time from randomization to the patient's discharge (Per-protocol analysis).
Outcome measures
| Measure |
St-FMOT
n=38 Participants
Children who received Standard Face Mask Oxygen Therapy
|
HFNCOT
n=38 Participants
Children who received High-Flow Nasal Cannula Oxygen Therapy
|
|---|---|---|
|
Length of Hospital Stay (Per-protocol Analysis)
|
5 day
Interval 4.0 to 6.0
|
5 day
Interval 4.0 to 7.0
|
SECONDARY outcome
Timeframe: 4 hoursPopulation: The population of the intention to treat.
The number of treatment failures at 4 hours in each study arm (Intention-to-treat analysis).
Outcome measures
| Measure |
St-FMOT
n=48 Participants
Children who received Standard Face Mask Oxygen Therapy
|
HFNCOT
n=39 Participants
Children who received High-Flow Nasal Cannula Oxygen Therapy
|
|---|---|---|
|
Treatment Failure at 4 Hours (Intention-to-treat Analysis)
|
10 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: through study completion, an average of 168 hoursPopulation: Intention to treat analysis.
The number of participants admitted to the intensive care unit for invasive mechanical ventilation (Intention-to-treat analysis).
Outcome measures
| Measure |
St-FMOT
n=48 Participants
Children who received Standard Face Mask Oxygen Therapy
|
HFNCOT
n=39 Participants
Children who received High-Flow Nasal Cannula Oxygen Therapy
|
|---|---|---|
|
Pediatric Intensive Care Unit Admission (Intention-to-treat Analysis).
|
10 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: through study completion, an average of 168 hoursPopulation: Intention to treat analysis.
The number of participants with any adverse events in therapy groups (Intention-to-treat analysis).
Outcome measures
| Measure |
St-FMOT
n=48 Participants
Children who received Standard Face Mask Oxygen Therapy
|
HFNCOT
n=39 Participants
Children who received High-Flow Nasal Cannula Oxygen Therapy
|
|---|---|---|
|
Adverse Events of Therapy (Intention-to-treat Analysis)
|
1 Participants
|
5 Participants
|
Adverse Events
Active Comparator: High-Flow Nasal Cannula Oxygen Therapy
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Active Comparator: Standard Face Mask Oxygen Therapy
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active Comparator: High-Flow Nasal Cannula Oxygen Therapy
n=39 participants at risk
Children in the high-flow group received heated and humidified high-flow oxygen at a rate of 2 L\*kg/min (maximum 25 L/min), using an age-appropriate Optiflow Junior cannula and Airvo 2 high-flow system (Fisher and Paykel Healthcare). The initial fraction of inspired oxygen (FiO2) was set at 40%. The starting flow rate continued for a minimum of 4 hours. According to the patients' clinical response, the flow rate was decreased by 0.5 L\*kg/min per hour. The FiO2 was adjusted to obtain the oxygen saturation levels between 92-98%. When the flow rate was at 0.5 L\*kg/min, and the FiO2 was equal to the ambient oxygen concentration, High-Flow nasal cannula oxygen therapy was stopped.
|
Active Comparator: Standard Face Mask Oxygen Therapy
n=48 participants at risk
Children in the standard-therapy group received supplemental oxygen via a simple face mask, a range of 6-10 L/min, to maintain the oxygen saturation level between 92-98%. Those who sustained the oxygen saturation \>92% in the ambient oxygen concentration were weaned off Standard Face Mask Oxygen Therapy.
|
|---|---|---|
|
Cardiac disorders
Transient bradicardia
|
7.7%
3/39 • Adverse event data were collected for 6 weeks.
|
2.1%
1/48 • Adverse event data were collected for 6 weeks.
|
|
General disorders
Epistaxis
|
5.1%
2/39 • Adverse event data were collected for 6 weeks.
|
0.00%
0/48 • Adverse event data were collected for 6 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place