CompletedNCT04245202Updated Feb 16, 2021Results posted

Comparison of High Flow Nasal Cannula and Standard Face Mask Oxygen Therapy in Children With Bronchiolitis

An interventional study of HFNCOT and St-FMOT in Acute Bronchiolitis, sponsored by Ege University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 1 Month to 24 Months. Per ClinicalTrials.gov, last updated 2021-02-16.

Sponsored by Ege University · Not applicable, Interventional, and Treatment

From the registry’s dates

Registered 2 years 10 months after the study started (first participant enrolled Mar 2017, registered Jan 2020).

Phase: Not applicable
Study type: Interventional
Enrollment: 87
Allocation: Randomized
Ages: 1 Month to 24 Months
Sex: All

Study summary

The study aims to compare the efficacy of two different oxygenation methods on decrease respiratory rate, heart rate, and clinical respiratory score in children with moderate to severe bronchiolitis requiring oxygen therapy.

Standard face mask oxygen therapy (St-FMOT)
High-flow nasal cannula oxygen therapy (HFNCOT)

Read the detailed description

Bronchiolitis is the most common cause of hospitalization for children under one year of age and, caused by respiratory viruses. Although several medications and interventions studied for bronchiolitis treatment, hydration and oxygenation are the main treatments. High-flow nasal cannula oxygen therapy (HFNCOT) has been widely used to provide respiratory support in children with acute respiratory diseases.

Patients had earlier improvement with HFNCOT to decrease the respiratory rate and respiratory effort than patients with standard low-flow oxygen therapy (SOT).

HFNCOT therapy reduced more effective in heart rate, respiratory effort, and length of supportive oxygen treatment (LOOT) compared with SOT. However, the length of hospital stay (LOS) and feeding ability had better consequences in patients with moderate and severe bronchiolitis treated with HFNCOT.

Another published study shows that in infants with acute bronchiolitis, which required oxygen therapy, there was no significant difference between therapy groups in terms of LOOT, LOS, and admission to the intensive care unit (ICU). HFNCOT was more efficient than SOT and reduced the rate of intubation/invasive ventilation in severe bronchiolitis management. Despite these beneficial effects of HFNCOT, it was not recommended by international guidelines yet. However, well designed, prospective randomized controlled trials are still needed to use this therapy in the wards.

Conditions studied

Acute Bronchiolitis

Keywords

Acute Bronchiolitis
High Flow Nasal Cannula
Standard Face Mask

In context

Lead sponsor

Ege University is the lead sponsor of 375 studies on the registry; 47 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 1 Month to 24 Months
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Children aged between 1-24 months applied with moderate and severe bronchiolitis requiring supplemental oxygen were eligible for the study.
The severity of bronchiolitis was assessed according to the clinical respiratory score (CRS) of Liu et al. (5). The patients with CRS ≥5 were included.
Peripheral oxyhemoglobin saturation is \< 92%.

Exclusion criteria

Exclusion criteria:

Children admitted to the ICU for urgent invasive mechanical ventilation;
those who received standard oxygen therapy (SOT) or HFNCOT at other facilities before arrival;
those with an underlying medical condition (such as congenital heart disease, chronic lung disease, neuromuscular disease, metabolic disease, or immunocompromised);
those who had a craniofacial malformation, an upper airway obstruction, pneumothorax, or nasal trauma, and missing parental consent or a refused permission of the participant.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 87 participants (actual)

Study arms

Active comparator
Active Comparator: HFNCOT
Set between 2 to 25 l/min, adjusted to obtain peripheral oxygen saturation \>92%.
Device: HFNCOT
Active comparator
Active Comparator: St-FMOT
To obtain oxygen saturation \>92%
Other: St-FMOT

Interventions

DeviceHFNCOT
The patient will receive a high flow nasal of humidified oxygen, set between 2 to 25 l/min. The inspired fraction of oxygen (FiO2) will be adjusted to obtain the oxygen saturation \>92%.
OtherSt-FMOT
The inspired fraction of oxygen (FiO2) will be adjusted to obtain the oxygen saturation \>92%.

What researchers measure

Primary outcomes

Time Taken to Reach the Normal Range for Heart Rate (Per-protocol Analysis)
The time that heart rate takes into the normal range for age between the groups (Per-protocol analysis).
Time frame: through study completion, an average of 96 hours
Time Taken to Reach the Normal Range for Respiratory Rate (Per-protocol Analysis)
The time that the respiratory rate takes into the normal range for age between the groups (Per-protocol analysis).
Time frame: through study completion, an average of 96 hours
Time Taken to Regress A Lower Clinical Respiratory Score (Per-protocol Analysis)
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.
Time frame: through study completion, an average of 96 hours

Secondary outcomes

Heart Rate (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).
Time frame: Baseline, 1,2,4,12,24,48,72 and 96 hours
Heart Rate (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).
Time frame: Baseline, 1,2,4,12,24,48,72 and 96 hours
Respiratory Rate (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).
Time frame: Baseline, 1,2,4,12,24,48,72 and 96 hours
Respiratory Rate (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).
Time frame: Baseline, 1,2,4,12,24,48,72 and 96 hours
Clinical Respiratory Score (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.
Time frame: Baseline, 1,2,4,12,24,48,72 and 96 hours
Clinical Respiratory Score (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.
Time frame: Baseline, 1,2,4,12,24,48,72 and 96 hours
Oxygen Requirement (Intention-to-treat Analysis)
The total duration of oxygen therapy (Intention-to-treat analysis).
Time frame: through study completion, an average of 168 hours
Oxygen Requirement (Per-protocol Analysis)
The total duration of oxygen therapy (Per-protocol analysis).
Time frame: through study completion, an average of 168 hours
Length of Hospital Stay (Intention-to-treat Analysis)
The time from randomization to the patient's discharge (Intention-to-treat analysis).
Time frame: through study completion, an average of 168 hours
Length of Hospital Stay (Per-protocol Analysis)
The time from randomization to the patient's discharge (Per-protocol analysis).
Time frame: through study completion, an average of 168 hours
Treatment Failure at 4 Hours (Intention-to-treat Analysis)
The number of treatment failures at 4 hours in each study arm (Intention-to-treat analysis).
Time frame: 4 hours
Pediatric Intensive Care Unit Admission (Intention-to-treat Analysis).
The number of participants admitted to the intensive care unit for invasive mechanical ventilation (Intention-to-treat analysis).
Time frame: through study completion, an average of 168 hours
Adverse Events of Therapy (Intention-to-treat Analysis)
The number of participants with any adverse events in therapy groups (Intention-to-treat analysis).
Time frame: through study completion, an average of 168 hours

Results

Posted Feb 16, 2021

Limitations and caveats

The study was performed in a single center and had a limited sample size. We did not blind the allocation of oxygen therapies to introduce the risk of performance bias. We did not reach the number of participants calculated with the power analysis because of the financial support problem. Therefore, we used effect size for each of the primary outcomes. Patients were not allocated to receive therapy in a ratio of 1:1. Hence, a numerical difference occurred between the two groups.

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.

Participant flow — Overall Study
Milestone	St-FMOT	HFNCOT
Started	48	39
Completed	38	38
Not completed	10	1
Withdrew: Lack of efficacy	10	1

Outcome measures

PrimaryTime Taken to Reach the Normal Range for Heart Rate (Per-protocol Analysis)

The time that heart rate takes into the normal range for age between the groups (Per-protocol analysis).

Time frame:: through study completion, an average of 96 hours
Reported as:: Median · hour

Time Taken to Reach the Normal Range for Heart Rate (Per-protocol Analysis)
hour	St-FMOT	HFNCOT
Time Taken to Reach the Normal Range for Heart Rate (Per-protocol Analysis)	12 (2 to 24)	2 (1 to 4)

Statistical analysis

St-FMOT vs HFNCOT · Wilcoxon (Mann-Whitney) · p = <0.001

PrimaryTime Taken to Reach the Normal Range for Respiratory Rate (Per-protocol Analysis)

The time that the respiratory rate takes into the normal range for age between the groups (Per-protocol analysis).

Time frame:: through study completion, an average of 96 hours
Reported as:: Median · hour

Time Taken to Reach the Normal Range for Respiratory Rate (Per-protocol Analysis)
hour	St-FMOT	HFNCOT
Time Taken to Reach the Normal Range for Respiratory Rate (Per-protocol Analysis)	24 (4 to 48)	4 (2 to 12)

Statistical analysis

St-FMOT vs HFNCOT · Wilcoxon (Mann-Whitney) · p = <0.001

PrimaryTime Taken to Regress A Lower Clinical Respiratory Score (Per-protocol Analysis)

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.

Time frame:: through study completion, an average of 96 hours
Reported as:: Median · hour

Time Taken to Regress A Lower Clinical Respiratory Score (Per-protocol Analysis)
hour	St-FMOT	HFNCT
Time Taken to Regress A Lower Clinical Respiratory Score (Per-protocol Analysis)	4 (2 to 24)	2 (1 to 4)

Statistical analysis

St-FMOT vs HFNCT · Wilcoxon (Mann-Whitney) · p = 0.003

SecondaryHeart Rate (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).

Time frame:: Baseline, 1,2,4,12,24,48,72 and 96 hours
Reported as:: Least squares mean · beats per minute

Heart Rate (Intention-to-treat Analysis)
beats per minute	St-FMOT	HFNCOT
Baseline	172.90 (167.68 to 178.64)	171.05 (165.26 to 176.84)
1 hour	166.21 (160.99 to 171.43)	151.28 (145.49 to 157.07)
2 hours	164.00 (158.78 to 169.22)	146.59 (140.80 to 152.38)
4 hours	159.65 (154.43 to 164.86)	138.05 (132.26 to 143.84)
12 hours	153.43 (147.88 to 158.98)	132.47 (126.64 to 138.29)
24 hours	142.96 (137.25 to 148.67)	132.56 (126.71 to 138.40)
48 hours	139.21 (133.42 to 145.00)	128.48 (122.63 to 134.34)
72 hours	135.99 (130.09 to 141.90)	124.96 (118.92 to 130.99)
96 hours	133.61 (127.60 to 139.62)	119.47 (113.15 to 125.80)

Statistical analysis

St-FMOT vs HFNCOT · Mixed Models Analysis · p = <0.001 (The p-Value of the interaction between time and groups was given. In all analyses, p values \<0·05 were considered being statistically significant.) · Mean difference (net): -12.29 · 95% CI -23.53 to -1.05Treatment difference= High-Flow Nasal Cannula Oxygen Therapy (96-0 h) - Standard Face Mask Oxygen Therapy (96-0 h) (based on least-square means)

SecondaryHeart Rate (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).

Time frame:: Baseline, 1,2,4,12,24,48,72 and 96 hours
Reported as:: Least squares mean · beats per minute

Heart Rate (Per-protocol Analysis)
beats per minute	St-FMOT	HFNCOT
Baseline	169.03 (164.22 to 173.83)	170.37 (165.56 to 175.17)
1 hour	160.76 (155.96 to 165.57)	150.37 (145.56 to 155.17)
2 hours	157.58 (152.77 to 162.38)	145.39 (140.59 to 150.20)
4 hours	150.66 (145.85 to 155.46)	136.42 (131.62 to 141.23)
12 hours	147.08 (142.27 to 151.88)	131.32 (126.51 to 136.54)
24 hours	138.45 (133.64 to 143.25)	131.74 (126.93 to 136.54)
48 hours	135.97 (131.17 to 140.78)	127.89 (123.09 to 132.70)
72 hours	136.43 (131.54 to 141.31)	124.57 (119.60 to 129.54)
96 hours	133.85 (128.90 to 138.81)	122.53 (117.30 to 127.76)

Statistical analysis

St-FMOT vs HFNCOT · Mixed Models Analysis · p = <0.001 · Mean difference (net): -12.66 · 95% CI -22.05 to -3.28Treatment difference= High-Flow Nasal Cannula Oxygen Therapy (96-0 h) - Standard Face Mask Oxygen Therapy (96-0 h) (based on least-square means)

SecondaryRespiratory Rate (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).

Time frame:: Baseline, 1,2,4,12,24,48,72 and 96 hours
Reported as:: Median · Breaths per minute

Respiratory Rate (Intention-to-treat Analysis)
Breaths per minute	St-FMOT	HFNCOT
Baseline	65.08 (62.77 to 67.39)	66.71 (64.15 to 69.27)
1 hour	60.20 (57.89 to 62.51)	56.84 (54.28 to 59.40)
2 hours	57.45 (55.14 to 59.76)	51.10 (48.54 to 53.66)
4 hours	55.54 (53.23 to 57.85)	46.56 (44.00 to 49.12)
12 hours	51.06 (48.63 to 53.48)	44.15 (41.57 to 46.72)
24 hours	46.54 (44.05 to 49.03)	40.82 (38.24 to 43.40)
48 hours	41.89 (39.36 to 44.42)	39.32 (36.74 to 41.91)
72 hours	39.24 (36.65 to 41.82)	36.70 (34.07 to 39.34)
96 hours	37.75 (35.12 to 40.38)	35.47 (32.79 to 38.22)

Statistical analysis

St-FMOT vs HFNCOT · Mixed Models Analysis · p = <0.001 (The p-Value of the interaction between time and groups was given. In all analysis, p values \<0.05 were considered being statistically significant.) · Mean difference (net): -3.91 · 95% CI -8.68 to 0.86Treatment difference= High-Flow Nasal Cannula Oxygen Therapy (96-0 h) - Standard Face Mask Oxygen Therapy (96-0 h) (based on least-square means)

SecondaryRespiratory Rate (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).

Time frame:: Baseline, 1,2,4,12,24,48,72 and 96 hours
Reported as:: Median · breaths per minute

Respiratory Rate (Per-protocol Analysis)
breaths per minute	St-FMOT	HFNCOT
Baseline	65.52 (63.15 to 67.89)	66.68 (64.31 to 69.05)
1 hour	59.50 (57.12 to 61.87)	56.60 (54.23 to 58.97)
2 hours	55.34 (52.96 to 57.71)	50.65 (48.28 to 53.03)
4 hours	51.81 (49.44 to 54.18)	46.00 (43.62 to 48.37)
12 hours	48.13 (45.75 to 50.50)	43.71 (41.33 to 46.08)
24 hours	44.23 (41.86 to 46.60)	40.47 (38.10 to 42.84)
48 hours	40.07 (37.70 to 42.45)	39.05 (36.68 to 41.42)
72 hours	37.82 (35.42 to 40.22)	36.51 (34.09 to 38.92)
96 hours	36.63 (34.20 to 39.06)	35.37 (32.85 to 37.89)

Statistical analysis

St-FMOT vs HFNCOT · Mixed Models Analysis · p = 0.003 · Mean difference (net): -2.41 · 95% CI -6.62 to 1.78Treatment difference= High-Flow Nasal Cannula Oxygen Therapy (96-0 h) - Standard Face Mask Oxygen Therapy (96-0 h) (based on least-square means)

SecondaryClinical Respiratory Score (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.

Time frame:: Baseline, 1,2,4,12,24,48,72 and 96 hours
Reported as:: Median · score on a scale

Clinical Respiratory Score (Intention-to-treat Analysis)
score on a scale	St-FMOT	HFNCOT
Baseline	9.0 (7.0 to 10.0)	10.0 (9.0 to 11.0)
1 hour	8.0 (6.5 to 10.0)	7.0 (7.0 to 9.0)
2 hours	8.0 (6.0 to 10.0)	6.0 (5.0 to 8.0)
4 hours	7.0 (6.0 to 9.5)	5.0 (4.0 to 7.0)
12 hours	5.0 (4.0 to 7.0)	5.0 (3.0 to 6.0)
24 hours	4.5 (3.0 to 6.0)	4.0 (2.0 to 5.0)
48 hours	3.5 (2.0 to 5.0)	2.0 (1.0 to 4.0)
72 hours	2.0 (1.0 to 4.0)	2.0 (1.0 to 3.0)
96 hours	1.0 (0.0 to 3.0)	1.0 (0.0 to 2.0)

Statistical analysis

St-FMOT vs HFNCOT · Brunner-Langer Method · p = 0.002 (The p-Value of the interaction between time and groups was given. In all analysis, p values \<0.05 were considered being statistically significant.) · Relative treatment effect difference: -0.07Relative Treatment Effect Difference= High-Flow Nasal Cannula Oxygen Therapy (96-0 h) - Standard Face Mask Oxygen Therapy (96-0 h) (based on least-square means)

SecondaryClinical Respiratory Score (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.

Time frame:: Baseline, 1,2,4,12,24,48,72 and 96 hours
Reported as:: Median · score on a scale

Clinical Respiratory Score (Per-protocol Analysis)
score on a scale	St-FMOT	HFNCOT
Baseline	9.0 (7.0 to 10.2)	9.5 (8.7 to 11.0)
1 hour	8.0 (6.0 to 9.0)	7.0 (7.0 to 9.0)
2 hours	7.0 (5.7 to 8.0)	6.0 (5.0 to 8.0)
4 hours	6.0 (5.0 to 8.0)	5.0 (4.0 to 6.2)
12 hours	5.0 (4.0 to 7.0)	5.0 (3.0 to 6.0)
24 hours	4.5 (2.7 to 6.0)	4.0 (2.0 to 5.0)
48 hours	3.5 (2.0 to 5.0)	2.0 (1.0 to 4.0)
72 hours	2.0 (1.0 to 4.0)	2.0 (1.0 to 3.0)
96 hours	1.0 (0.0 to 3.0)	1.0 (0.0 to 2.0)

Statistical analysis

St-FMOT vs HFNCOT · Brunner-Langer Method · p = 0.001 (The p-Value of the interaction between time and groups was given. In all analysis, p values \<0.05 were considered being statistically significant.) · Relative treatment effect difference: -0.08Relative Treatment Effect Difference= High-Flow Nasal Cannula Oxygen Therapy (96-0 h) - Standard Face Mask Oxygen Therapy (96-0 h) (based on least-square means)

SecondaryOxygen Requirement (Intention-to-treat Analysis)

The total duration of oxygen therapy (Intention-to-treat analysis).

Time frame:: through study completion, an average of 168 hours
Reported as:: Median · hour

Oxygen Requirement (Intention-to-treat Analysis)
hour	St-FMOT	HFNCOT
Oxygen Requirement (Intention-to-treat Analysis)	29.5 (14.0 to 45.7)	19.0 (4.0 to 30.0)

SecondaryOxygen Requirement (Per-protocol Analysis)

The total duration of oxygen therapy (Per-protocol analysis).

Time frame:: through study completion, an average of 168 hours
Reported as:: Median · hour

Oxygen Requirement (Per-protocol Analysis)
hour	St-FMOT	HFNCOT
Oxygen Requirement (Per-protocol Analysis)	24.0 (12.0 to 38.5)	18.5 (4.0 to 30.0)

Statistical analysis

St-FMOT vs HFNCOT · Wilcoxon (Mann-Whitney) · p = 0.08

SecondaryLength of Hospital Stay (Intention-to-treat Analysis)

The time from randomization to the patient's discharge (Intention-to-treat analysis).

Time frame:: through study completion, an average of 168 hours
Reported as:: Median · day

Length of Hospital Stay (Intention-to-treat Analysis)
day	St-FMOT	HFNCOT
Length of Hospital Stay (Intention-to-treat Analysis)	5.5 (4.0 to 7.7)	5.0 (4.0 to 7.0)

Statistical analysis

St-FMOT vs HFNCOT · Wilcoxon (Mann-Whitney) · p = 0.22

SecondaryLength of Hospital Stay (Per-protocol Analysis)

The time from randomization to the patient's discharge (Per-protocol analysis).

Time frame:: through study completion, an average of 168 hours
Reported as:: Median · day

Length of Hospital Stay (Per-protocol Analysis)
day	St-FMOT	HFNCOT
Length of Hospital Stay (Per-protocol Analysis)	5 (4 to 6)	5 (4 to 7)

Statistical analysis

St-FMOT vs HFNCOT · Wilcoxon (Mann-Whitney) · p = 0.99

SecondaryTreatment Failure at 4 Hours (Intention-to-treat Analysis)

The number of treatment failures at 4 hours in each study arm (Intention-to-treat analysis).

Time frame:: 4 hours
Reported as:: Count of participants · Participants

Treatment Failure at 4 Hours (Intention-to-treat Analysis)
Participants	St-FMOT	HFNCOT
Treatment Failure at 4 Hours (Intention-to-treat Analysis)	10	1

Statistical analysis

St-FMOT vs HFNCOT · Fisher Exact · p = 0.02

SecondaryPediatric Intensive Care Unit Admission (Intention-to-treat Analysis).

The number of participants admitted to the intensive care unit for invasive mechanical ventilation (Intention-to-treat analysis).

Time frame:: through study completion, an average of 168 hours
Reported as:: Count of participants · Participants

Pediatric Intensive Care Unit Admission (Intention-to-treat Analysis).
Participants	St-FMOT	HFNCOT
Pediatric Intensive Care Unit Admission (Intention-to-treat Analysis).	10	1

Statistical analysis

St-FMOT vs HFNCOT · Fisher Exact · p = 0.02

SecondaryAdverse Events of Therapy (Intention-to-treat Analysis)

The number of participants with any adverse events in therapy groups (Intention-to-treat analysis).

Time frame:: through study completion, an average of 168 hours
Reported as:: Count of participants · Participants

Adverse Events of Therapy (Intention-to-treat Analysis)
Participants	St-FMOT	HFNCOT
Adverse Events of Therapy (Intention-to-treat Analysis)	1	5

Statistical analysis

St-FMOT vs HFNCOT · Fisher Exact · p = 0.08

Adverse events

Collected over Adverse event data were collected for 6 weeks.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Active Comparator: High-Flow Nasal Cannula Oxygen Therapy	0/39 (0%)	0/39 (0%)	5/39 (12.8%)
Active Comparator: Standard Face Mask Oxygen Therapy	0/48 (0%)	0/48 (0%)	1/48 (2.1%)

Most frequent other events

Most frequent other events
Event	Active Comparator: High-Flow Nasal Cannula Oxygen Therapy	Active Comparator: Standard Face Mask Oxygen Therapy
Transient bradicardiaCardiac disorders	3/39	1/48
EpistaxisGeneral disorders	2/39	0/48

Baseline characteristics

Baseline demographic characteristics of participants according to allocation (Intention-to-treat analysis)

Age, Continuous
Age, Continuous(months)	St-FMOT	HFNCOT	Total
Median	6.5 (3.6 to 11.0)	6.0 (3.0 to 12.0)	6.0 (3.5 to 11.0)

Sex: Female, Male
Sex: Female, Male(Participants)	St-FMOT	HFNCOT	Total
Female	21	15	36
Male	27	24	51

Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)	St-FMOT	HFNCOT	Total
Count of participants	—	—	0

Region of Enrollment
Region of Enrollment(participants)	St-FMOT	HFNCOT	Total
Turkey	48	39	87

Gestational age at birth
Gestational age at birth(Participants)	St-FMOT	HFNCOT	Total
Prematurity (< 37 weeks)	7	8	15
Term infant (> 36 weeks)	41	31	72

Weight at the admission (kg)
Weight at the admission (kg)(kilogram)	St-FMOT	HFNCOT	Total
Median	7.4 (6.0 to 9.5)	8.0 (5.1 to 10.0)	8.0 (6.0 to 9.7)

Baseline heart rate
Baseline heart rate(beat per minute)	St-FMOT	HFNCOT	Total
Median	174.0 (156.2 to 186.5)	170.0 (157.0 to 188.0)	173.0 (157.0 to 188.0)

Baseline respiratory rate
Baseline respiratory rate(Breaths per minute)	St-FMOT	HFNCOT	Total
Median	64.5 (60.0 to 70.0)	66.0 (60.0 to 72.0)	66.0 (60.0 to 70.0)

6 further baseline measures are reported on the registry.

Study locations

1 site

Ege University Medical Faculty
Izmir, Select A State 35100, Turkey (Türkiye)

References and documents

Publications

Franklin D, Babl FE, Schlapbach LJ, Oakley E, Craig S, Neutze J, Furyk J, Fraser JF, Jones M, Whitty JA, Dalziel SR, Schibler A. A Randomized Trial of High-Flow Oxygen Therapy in Infants with Bronchiolitis. N Engl J Med. 2018 Mar 22;378(12):1121-1131. doi: 10.1056/NEJMoa1714855. PubMed 29562151 ↗
Franklin D, Dalziel S, Schlapbach LJ, Babl FE, Oakley E, Craig SS, Furyk JS, Neutze J, Sinn K, Whitty JA, Gibbons K, Fraser J, Schibler A; PARIS and PREDICT. Early high flow nasal cannula therapy in bronchiolitis, a prospective randomised control trial (protocol): A Paediatric Acute Respiratory Intervention Study (PARIS). BMC Pediatr. 2015 Nov 14;15:183. doi: 10.1186/s12887-015-0501-x. PubMed 26572729 ↗
Liu G, Fan C, Wu H. High-flow nasal cannula therapies for respiratory management in pediatric patients. Minerva Pediatr. 2018 Oct;70(5):488-492. doi: 10.23736/S0026-4946.17.04781-8. Epub 2017 Mar 27. PubMed 28353318 ↗
Pham TM, O'Malley L, Mayfield S, Martin S, Schibler A. The effect of high flow nasal cannula therapy on the work of breathing in infants with bronchiolitis. Pediatr Pulmonol. 2015 Jul;50(7):713-20. doi: 10.1002/ppul.23060. Epub 2014 May 21. PubMed 24846750 ↗
Bressan S, Balzani M, Krauss B, Pettenazzo A, Zanconato S, Baraldi E. High-flow nasal cannula oxygen for bronchiolitis in a pediatric ward: a pilot study. Eur J Pediatr. 2013 Dec;172(12):1649-56. doi: 10.1007/s00431-013-2094-4. Epub 2013 Jul 31. PubMed 23900520 ↗
Milesi C, Pierre AF, Deho A, Pouyau R, Liet JM, Guillot C, Guilbert AS, Rambaud J, Millet A, Afanetti M, Guichoux J, Genuini M, Mansir T, Bergounioux J, Michel F, Marcoux MO, Baleine J, Durand S, Durand P, Dauger S, Javouhey E, Leteurtre S, Brissaud O, Renolleau S, Portefaix A, Douillard A, Cambonie G; GFRUP Respiratory Study Group. A multicenter randomized controlled trial of a 3-L/kg/min versus 2-L/kg/min high-flow nasal cannula flow rate in young infants with severe viral bronchiolitis (TRAMONTANE 2). Intensive Care Med. 2018 Nov;44(11):1870-1878. doi: 10.1007/s00134-018-5343-1. Epub 2018 Oct 21. PubMed 30343318 ↗
Mace AO, Gibbons J, Schultz A, Knight G, Martin AC. Humidified high-flow nasal cannula oxygen for bronchiolitis: should we go with the flow? Arch Dis Child. 2018 Mar;103(3):303. doi: 10.1136/archdischild-2017-313950. Epub 2017 Sep 13. No abstract available. PubMed 28903952 ↗
Testa G, Iodice F, Ricci Z, Vitale V, De Razza F, Haiberger R, Iacoella C, Conti G, Cogo P. Comparative evaluation of high-flow nasal cannula and conventional oxygen therapy in paediatric cardiac surgical patients: a randomized controlled trial. Interact Cardiovasc Thorac Surg. 2014 Sep;19(3):456-61. doi: 10.1093/icvts/ivu171. Epub 2014 Jun 8. PubMed 24912486 ↗
Milesi C, Boubal M, Jacquot A, Baleine J, Durand S, Odena MP, Cambonie G. High-flow nasal cannula: recommendations for daily practice in pediatrics. Ann Intensive Care. 2014 Sep 30;4:29. doi: 10.1186/s13613-014-0029-5. eCollection 2014. PubMed 25593745 ↗
Schibler A, Franklin D. Respiratory support for children in the emergency department. J Paediatr Child Health. 2016 Feb;52(2):192-6. doi: 10.1111/jpc.13078. PubMed 27062623 ↗
Da Dalt L, Bressan S, Martinolli F, Perilongo G, Baraldi E. Treatment of bronchiolitis: state of the art. Early Hum Dev. 2013 Jun;89 Suppl 1:S31-6. doi: 10.1016/S0378-3782(13)70011-2. PubMed 23809346 ↗
Beggs S, Wong ZH, Kaul S, Ogden KJ, Walters JA. High-flow nasal cannula therapy for infants with bronchiolitis. Cochrane Database Syst Rev. 2014 Jan 20;2014(1):CD009609. doi: 10.1002/14651858.CD009609.pub2. PubMed 24442856 ↗
Eski A, Ozturk GK, Turan C, Ozgul S, Gulen F, Demir E. High-flow nasal cannula oxygen in children with bronchiolitis: A randomized controlled trial. Pediatr Pulmonol. 2022 Jun;57(6):1527-1534. doi: 10.1002/ppul.25893. Epub 2022 Mar 28. PubMed 35293153 ↗

Study documents

Protocol and statistical analysis plan · Mar 10, 2017

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Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 16, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

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Key details

Study ID: NCT04245202
Lead sponsor: Ege University
Responsible party: Aykut Eşki (Medical Doctor, Pediatric Pulmonology, Ege University) — Principal investigator
First posted: Jan 28, 2020
Start date: Mar 14, 2017
Primary completion: Mar 10, 2020
Completion: Mar 10, 2020
Results posted: Feb 16, 2021
Last update: Feb 16, 2021

Study contacts

Aykut Eşki, MD

principal investigator · Ege University Medical Study

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FDA-regulated drug: No
FDA-regulated device: No

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Comparison of High Flow Nasal Cannula and Standard Face Mask Oxygen Therapy in Children With Bronchiolitis

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