Acute Bronchiolitis
Conditions
Keywords
Acute Bronchiolitis, High Flow Nasal Cannula, Standard Face Mask
Brief 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. 1. Standard face mask oxygen therapy (St-FMOT) 2. High-flow nasal cannula oxygen therapy (HFNCOT)
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.
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%.
Sponsors
Ege University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Months to 24 Months
Healthy volunteers
No
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time Taken to Reach the Normal Range for Heart Rate (Per-protocol Analysis) | through study completion, an average of 96 hours | The time that heart rate takes into the normal range for age between the groups (Per-protocol analysis). |
| Time Taken to Reach the Normal Range for Respiratory Rate (Per-protocol Analysis) | through study completion, an average of 96 hours | The time that the respiratory rate takes into the normal range for age between the groups (Per-protocol analysis). |
| Time Taken to Regress A Lower Clinical Respiratory Score (Per-protocol Analysis) | through study completion, an average of 96 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory Rate (Per-protocol Analysis) | Baseline, 1,2,4,12,24,48,72 and 96 hours | 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). |
| Clinical Respiratory Score (Intention-to-treat Analysis) | Baseline, 1,2,4,12,24,48,72 and 96 hours | 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. |
| Clinical Respiratory Score (Per-protocol Analysis) | Baseline, 1,2,4,12,24,48,72 and 96 hours | 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. |
| Oxygen Requirement (Intention-to-treat Analysis) | through study completion, an average of 168 hours | The total duration of oxygen therapy (Intention-to-treat analysis). |
| Oxygen Requirement (Per-protocol Analysis) | through study completion, an average of 168 hours | The total duration of oxygen therapy (Per-protocol analysis). |
| Heart Rate (Intention-to-treat Analysis) | Baseline, 1,2,4,12,24,48,72 and 96 hours | 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). |
| Length of Hospital Stay (Per-protocol Analysis) | through study completion, an average of 168 hours | The time from randomization to the patient's discharge (Per-protocol analysis). |
| Treatment Failure at 4 Hours (Intention-to-treat Analysis) | 4 hours | The number of treatment failures at 4 hours in each study arm (Intention-to-treat analysis). |
| Pediatric Intensive Care Unit Admission (Intention-to-treat Analysis). | through study completion, an average of 168 hours | The number of participants admitted to the intensive care unit for invasive mechanical ventilation (Intention-to-treat analysis). |
| Adverse Events of Therapy (Intention-to-treat Analysis) | through study completion, an average of 168 hours | The number of participants with any adverse events in therapy groups (Intention-to-treat analysis). |
| Length of Hospital Stay (Intention-to-treat Analysis) | through study completion, an average of 168 hours | The time from randomization to the patient's discharge (Intention-to-treat analysis). |
| Heart Rate (Per-protocol Analysis) | Baseline, 1,2,4,12,24,48,72 and 96 hours | 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). |
| Respiratory Rate (Intention-to-treat Analysis) | Baseline, 1,2,4,12,24,48,72 and 96 hours | 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). |
Countries
Turkey (Türkiye)
Participant flow
Recruitment details
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.
Pre-assignment details
No patients were excluded from the study after participant enrollment.
Participants by arm
| Arm | Count |
|---|---|
| St-FMOT Children who received standard face mask oxygen treatment | 48 |
| HFNCOT Children who received high flow nasal cannula oxygen treatment | 39 |
| Total | 87 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lack of Efficacy | 10 | 1 |
Baseline characteristics
| Characteristic | St-FMOT | HFNCOT | Total |
|---|---|---|---|
| Age, Continuous | 6.5 months | 6.0 months | 6.0 months |
| Baseline clinical respiratory score | 9.0 score on a scale | 9.5 score on a scale | 9.0 score on a scale |
| Baseline heart rate | 174.0 beat per minute | 170.0 beat per minute | 173.0 beat per minute |
| Baseline Oxygen Saturation | 88.0 percentage of saturated oxygen | 87.0 percentage of saturated oxygen | 88.0 percentage of saturated oxygen |
| Baseline respiratory rate | 64.5 Breaths per minute | 66.0 Breaths per minute | 66.0 Breaths per minute |
| Gestational age at birth Prematurity (< 37 weeks) | 7 Participants | 8 Participants | 15 Participants |
| Gestational age at birth Term infant (> 36 weeks) | 41 Participants | 31 Participants | 72 Participants |
| Number of detected virus 1 virus | 39 Participants | 32 Participants | 71 Participants |
| Number of detected virus 2 viruses | 7 Participants | 7 Participants | 14 Participants |
| Number of detected virus No virus | 2 Participants | 0 Participants | 2 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Turkey | 48 participants | 39 participants | 87 participants |
| Season admitted Autumn | 9 Participants | 7 Participants | 16 Participants |
| Season admitted Spring | 7 Participants | 4 Participants | 11 Participants |
| Season admitted Summer | 4 Participants | 3 Participants | 7 Participants |
| Season admitted Winter | 28 Participants | 25 Participants | 53 Participants |
| Severity of clinical respiratory score Moderate | 18 Participants | 9 Participants | 27 Participants |
| Severity of clinical respiratory score Severe | 30 Participants | 30 Participants | 60 Participants |
| Sex: Female, Male Female | 21 Participants | 15 Participants | 36 Participants |
| Sex: Female, Male Male | 27 Participants | 24 Participants | 51 Participants |
| Virus detected FLUA | 2 Participants | 1 Participants | 3 Participants |
| Virus detected HBoV | 4 Participants | 3 Participants | 7 Participants |
| Virus detected HBoV+hCOV | 0 Participants | 1 Participants | 1 Participants |
| Virus detected hCoV | 0 Participants | 0 Participants | 0 Participants |
| Virus detected hCOV+hAV | 1 Participants | 1 Participants | 2 Participants |
| Virus detected hMPV | 4 Participants | 2 Participants | 6 Participants |
| Virus detected hMPV+hCOV | 1 Participants | 0 Participants | 1 Participants |
| Virus detected HRV | 7 Participants | 4 Participants | 11 Participants |
| Virus detected HRV+FLUA | 0 Participants | 1 Participants | 1 Participants |
| Virus detected HRV+HBoV | 1 Participants | 0 Participants | 1 Participants |
| Virus detected No virus | 2 Participants | 0 Participants | 2 Participants |
| Virus detected PIV3 | 1 Participants | 1 Participants | 2 Participants |
| Virus detected RSV | 19 Participants | 21 Participants | 40 Participants |
| Virus detected RSV+FLUA | 2 Participants | 0 Participants | 2 Participants |
| Virus detected RSV+HBoV | 1 Participants | 0 Participants | 1 Participants |
| Virus detected RSV+hCOV | 1 Participants | 0 Participants | 1 Participants |
| Virus detected RSV+HRV | 0 Participants | 2 Participants | 2 Participants |
| Virus detected RSV+PIV2 | 1 Participants | 1 Participants | 2 Participants |
| Virus detected RSV+PIV3 | 1 Participants | 1 Participants | 2 Participants |
| Weight at the admission (kg) | 7.4 kilogram | 8.0 kilogram | 8.0 kilogram |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 39 | 0 / 48 |
| other Total, other adverse events | 5 / 39 | 1 / 48 |
| serious Total, serious adverse events | 0 / 39 | 0 / 48 |
Outcome results
Primary
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
Population: The population of the per-protocol.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| St-FMOT | Time Taken to Reach the Normal Range for Heart Rate (Per-protocol Analysis) | 12 hour |
| HFNCOT | Time Taken to Reach the Normal Range for Heart Rate (Per-protocol Analysis) | 2 hour |
p-value: <0.001Wilcoxon (Mann-Whitney)
Primary
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
Population: The population of the per-protocol.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| St-FMOT | Time Taken to Reach the Normal Range for Respiratory Rate (Per-protocol Analysis) | 24 hour |
| HFNCOT | Time Taken to Reach the Normal Range for Respiratory Rate (Per-protocol Analysis) | 4 hour |
p-value: <0.001Wilcoxon (Mann-Whitney)
Primary
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
Population: The population of the per-protocol.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| St-FMOT | Time Taken to Regress A Lower Clinical Respiratory Score (Per-protocol Analysis) | 4 hour |
| HFNCOT | Time Taken to Regress A Lower Clinical Respiratory Score (Per-protocol Analysis) | 2 hour |
p-value: 0.003Wilcoxon (Mann-Whitney)
Secondary
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
Population: Intention to treat analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| St-FMOT | Adverse Events of Therapy (Intention-to-treat Analysis) | 1 Participants |
| HFNCOT | Adverse Events of Therapy (Intention-to-treat Analysis) | 5 Participants |
p-value: 0.08Fisher Exact
Secondary
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
Population: Intention to treat analysis.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| St-FMOT | Clinical Respiratory Score (Intention-to-treat Analysis) | 1 hour | 8.0 score on a scale |
| St-FMOT | Clinical Respiratory Score (Intention-to-treat Analysis) | 24 hours | 4.5 score on a scale |
| St-FMOT | Clinical Respiratory Score (Intention-to-treat Analysis) | 4 hours | 7.0 score on a scale |
| St-FMOT | Clinical Respiratory Score (Intention-to-treat Analysis) | 48 hours | 3.5 score on a scale |
| St-FMOT | Clinical Respiratory Score (Intention-to-treat Analysis) | 2 hours | 8.0 score on a scale |
| St-FMOT | Clinical Respiratory Score (Intention-to-treat Analysis) | 72 hours | 2.0 score on a scale |
| St-FMOT | Clinical Respiratory Score (Intention-to-treat Analysis) | 12 hours | 5.0 score on a scale |
| St-FMOT | Clinical Respiratory Score (Intention-to-treat Analysis) | 96 hours | 1.0 score on a scale |
| St-FMOT | Clinical Respiratory Score (Intention-to-treat Analysis) | Baseline | 9.0 score on a scale |
| HFNCOT | Clinical Respiratory Score (Intention-to-treat Analysis) | 96 hours | 1.0 score on a scale |
| HFNCOT | Clinical Respiratory Score (Intention-to-treat Analysis) | Baseline | 10.0 score on a scale |
| HFNCOT | Clinical Respiratory Score (Intention-to-treat Analysis) | 1 hour | 7.0 score on a scale |
| HFNCOT | Clinical Respiratory Score (Intention-to-treat Analysis) | 2 hours | 6.0 score on a scale |
| HFNCOT | Clinical Respiratory Score (Intention-to-treat Analysis) | 4 hours | 5.0 score on a scale |
| HFNCOT | Clinical Respiratory Score (Intention-to-treat Analysis) | 12 hours | 5.0 score on a scale |
| HFNCOT | Clinical Respiratory Score (Intention-to-treat Analysis) | 24 hours | 4.0 score on a scale |
| HFNCOT | Clinical Respiratory Score (Intention-to-treat Analysis) | 48 hours | 2.0 score on a scale |
| HFNCOT | Clinical Respiratory Score (Intention-to-treat Analysis) | 72 hours | 2.0 score on a scale |
p-value: 0.002Brunner-Langer Method
Secondary
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
Population: Per-protocol analysis.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| St-FMOT | Clinical Respiratory Score (Per-protocol Analysis) | 1 hour | 8.0 score on a scale |
| St-FMOT | Clinical Respiratory Score (Per-protocol Analysis) | 24 hours | 4.5 score on a scale |
| St-FMOT | Clinical Respiratory Score (Per-protocol Analysis) | 4 hours | 6.0 score on a scale |
| St-FMOT | Clinical Respiratory Score (Per-protocol Analysis) | 48 hours | 3.5 score on a scale |
| St-FMOT | Clinical Respiratory Score (Per-protocol Analysis) | 2 hours | 7.0 score on a scale |
| St-FMOT | Clinical Respiratory Score (Per-protocol Analysis) | 72 hours | 2.0 score on a scale |
| St-FMOT | Clinical Respiratory Score (Per-protocol Analysis) | 12 hours | 5.0 score on a scale |
| St-FMOT | Clinical Respiratory Score (Per-protocol Analysis) | 96 hours | 1.0 score on a scale |
| St-FMOT | Clinical Respiratory Score (Per-protocol Analysis) | Baseline | 9.0 score on a scale |
| HFNCOT | Clinical Respiratory Score (Per-protocol Analysis) | 96 hours | 1.0 score on a scale |
| HFNCOT | Clinical Respiratory Score (Per-protocol Analysis) | Baseline | 9.5 score on a scale |
| HFNCOT | Clinical Respiratory Score (Per-protocol Analysis) | 1 hour | 7.0 score on a scale |
| HFNCOT | Clinical Respiratory Score (Per-protocol Analysis) | 2 hours | 6.0 score on a scale |
| HFNCOT | Clinical Respiratory Score (Per-protocol Analysis) | 4 hours | 5.0 score on a scale |
| HFNCOT | Clinical Respiratory Score (Per-protocol Analysis) | 12 hours | 5.0 score on a scale |
| HFNCOT | Clinical Respiratory Score (Per-protocol Analysis) | 24 hours | 4.0 score on a scale |
| HFNCOT | Clinical Respiratory Score (Per-protocol Analysis) | 48 hours | 2.0 score on a scale |
| HFNCOT | Clinical Respiratory Score (Per-protocol Analysis) | 72 hours | 2.0 score on a scale |
p-value: 0.001Brunner-Langer Method
Secondary
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
Population: Intention to treat analysis
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| St-FMOT | Heart Rate (Intention-to-treat Analysis) | 1 hour | 166.21 beats per minute |
| St-FMOT | Heart Rate (Intention-to-treat Analysis) | 24 hours | 142.96 beats per minute |
| St-FMOT | Heart Rate (Intention-to-treat Analysis) | 4 hours | 159.65 beats per minute |
| St-FMOT | Heart Rate (Intention-to-treat Analysis) | 48 hours | 139.21 beats per minute |
| St-FMOT | Heart Rate (Intention-to-treat Analysis) | 2 hours | 164.00 beats per minute |
| St-FMOT | Heart Rate (Intention-to-treat Analysis) | 72 hours | 135.99 beats per minute |
| St-FMOT | Heart Rate (Intention-to-treat Analysis) | 12 hours | 153.43 beats per minute |
| St-FMOT | Heart Rate (Intention-to-treat Analysis) | 96 hours | 133.61 beats per minute |
| St-FMOT | Heart Rate (Intention-to-treat Analysis) | Baseline | 172.90 beats per minute |
| HFNCOT | Heart Rate (Intention-to-treat Analysis) | 96 hours | 119.47 beats per minute |
| HFNCOT | Heart Rate (Intention-to-treat Analysis) | Baseline | 171.05 beats per minute |
| HFNCOT | Heart Rate (Intention-to-treat Analysis) | 1 hour | 151.28 beats per minute |
| HFNCOT | Heart Rate (Intention-to-treat Analysis) | 2 hours | 146.59 beats per minute |
| HFNCOT | Heart Rate (Intention-to-treat Analysis) | 4 hours | 138.05 beats per minute |
| HFNCOT | Heart Rate (Intention-to-treat Analysis) | 12 hours | 132.47 beats per minute |
| HFNCOT | Heart Rate (Intention-to-treat Analysis) | 24 hours | 132.56 beats per minute |
| HFNCOT | Heart Rate (Intention-to-treat Analysis) | 48 hours | 128.48 beats per minute |
| HFNCOT | Heart Rate (Intention-to-treat Analysis) | 72 hours | 124.96 beats per minute |
p-value: <0.00195% CI: [-23.53, -1.05]Mixed Models Analysis
Secondary
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
Population: Per-protocol analysis
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| St-FMOT | Heart Rate (Per-protocol Analysis) | 1 hour | 160.76 beats per minute |
| St-FMOT | Heart Rate (Per-protocol Analysis) | 24 hours | 138.45 beats per minute |
| St-FMOT | Heart Rate (Per-protocol Analysis) | 4 hours | 150.66 beats per minute |
| St-FMOT | Heart Rate (Per-protocol Analysis) | 48 hours | 135.97 beats per minute |
| St-FMOT | Heart Rate (Per-protocol Analysis) | 2 hours | 157.58 beats per minute |
| St-FMOT | Heart Rate (Per-protocol Analysis) | 72 hours | 136.43 beats per minute |
| St-FMOT | Heart Rate (Per-protocol Analysis) | 12 hours | 147.08 beats per minute |
| St-FMOT | Heart Rate (Per-protocol Analysis) | 96 hours | 133.85 beats per minute |
| St-FMOT | Heart Rate (Per-protocol Analysis) | Baseline | 169.03 beats per minute |
| HFNCOT | Heart Rate (Per-protocol Analysis) | 96 hours | 122.53 beats per minute |
| HFNCOT | Heart Rate (Per-protocol Analysis) | Baseline | 170.37 beats per minute |
| HFNCOT | Heart Rate (Per-protocol Analysis) | 1 hour | 150.37 beats per minute |
| HFNCOT | Heart Rate (Per-protocol Analysis) | 2 hours | 145.39 beats per minute |
| HFNCOT | Heart Rate (Per-protocol Analysis) | 4 hours | 136.42 beats per minute |
| HFNCOT | Heart Rate (Per-protocol Analysis) | 12 hours | 131.32 beats per minute |
| HFNCOT | Heart Rate (Per-protocol Analysis) | 24 hours | 131.74 beats per minute |
| HFNCOT | Heart Rate (Per-protocol Analysis) | 48 hours | 127.89 beats per minute |
| HFNCOT | Heart Rate (Per-protocol Analysis) | 72 hours | 124.57 beats per minute |
Comparison: The p-Value of the interaction between time and groups was given. In all analyses, p values \<0·05 were considered being statistically significant.p-value: <0.00195% CI: [-22.05, -3.28]Mixed Models Analysis
Secondary
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
Population: Intention to treat analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| St-FMOT | Length of Hospital Stay (Intention-to-treat Analysis) | 5.5 day |
| HFNCOT | Length of Hospital Stay (Intention-to-treat Analysis) | 5.0 day |
p-value: 0.22Wilcoxon (Mann-Whitney)
Secondary
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
Population: Per-protocol analysis
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| St-FMOT | Length of Hospital Stay (Per-protocol Analysis) | 5 day |
| HFNCOT | Length of Hospital Stay (Per-protocol Analysis) | 5 day |
p-value: 0.99Wilcoxon (Mann-Whitney)
Secondary
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
Population: Intention to treat analysis
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| St-FMOT | Oxygen Requirement (Intention-to-treat Analysis) | 29.5 hour |
| HFNCOT | Oxygen Requirement (Intention-to-treat Analysis) | 19.0 hour |
Secondary
Oxygen Requirement (Per-protocol Analysis)
The total duration of oxygen therapy (Per-protocol analysis).
Time frame: through study completion, an average of 168 hours
Population: Per-protocol analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| St-FMOT | Oxygen Requirement (Per-protocol Analysis) | 24.0 hour |
| HFNCOT | Oxygen Requirement (Per-protocol Analysis) | 18.5 hour |
p-value: 0.08Wilcoxon (Mann-Whitney)
Secondary
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
Population: Intention to treat analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| St-FMOT | Pediatric Intensive Care Unit Admission (Intention-to-treat Analysis). | 10 Participants |
| HFNCOT | Pediatric Intensive Care Unit Admission (Intention-to-treat Analysis). | 1 Participants |
p-value: 0.02Fisher Exact
Secondary
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
Population: Intention to treat analysis.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| St-FMOT | Respiratory Rate (Intention-to-treat Analysis) | 1 hour | 60.20 Breaths per minute |
| St-FMOT | Respiratory Rate (Intention-to-treat Analysis) | 24 hours | 46.54 Breaths per minute |
| St-FMOT | Respiratory Rate (Intention-to-treat Analysis) | 4 hours | 55.54 Breaths per minute |
| St-FMOT | Respiratory Rate (Intention-to-treat Analysis) | 48 hours | 41.89 Breaths per minute |
| St-FMOT | Respiratory Rate (Intention-to-treat Analysis) | 2 hours | 57.45 Breaths per minute |
| St-FMOT | Respiratory Rate (Intention-to-treat Analysis) | 72 hours | 39.24 Breaths per minute |
| St-FMOT | Respiratory Rate (Intention-to-treat Analysis) | 12 hours | 51.06 Breaths per minute |
| St-FMOT | Respiratory Rate (Intention-to-treat Analysis) | 96 hours | 37.75 Breaths per minute |
| St-FMOT | Respiratory Rate (Intention-to-treat Analysis) | Baseline | 65.08 Breaths per minute |
| HFNCOT | Respiratory Rate (Intention-to-treat Analysis) | 96 hours | 35.47 Breaths per minute |
| HFNCOT | Respiratory Rate (Intention-to-treat Analysis) | Baseline | 66.71 Breaths per minute |
| HFNCOT | Respiratory Rate (Intention-to-treat Analysis) | 1 hour | 56.84 Breaths per minute |
| HFNCOT | Respiratory Rate (Intention-to-treat Analysis) | 2 hours | 51.10 Breaths per minute |
| HFNCOT | Respiratory Rate (Intention-to-treat Analysis) | 4 hours | 46.56 Breaths per minute |
| HFNCOT | Respiratory Rate (Intention-to-treat Analysis) | 12 hours | 44.15 Breaths per minute |
| HFNCOT | Respiratory Rate (Intention-to-treat Analysis) | 24 hours | 40.82 Breaths per minute |
| HFNCOT | Respiratory Rate (Intention-to-treat Analysis) | 48 hours | 39.32 Breaths per minute |
| HFNCOT | Respiratory Rate (Intention-to-treat Analysis) | 72 hours | 36.70 Breaths per minute |
p-value: <0.00195% CI: [-8.68, 0.86]Mixed Models Analysis
Secondary
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
Population: Per-protocol analysis.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| St-FMOT | Respiratory Rate (Per-protocol Analysis) | Baseline | 65.52 breaths per minute |
| St-FMOT | Respiratory Rate (Per-protocol Analysis) | 12 hours | 48.13 breaths per minute |
| St-FMOT | Respiratory Rate (Per-protocol Analysis) | 2 hours | 55.34 breaths per minute |
| St-FMOT | Respiratory Rate (Per-protocol Analysis) | 48 hours | 40.07 breaths per minute |
| St-FMOT | Respiratory Rate (Per-protocol Analysis) | 1 hour | 59.50 breaths per minute |
| St-FMOT | Respiratory Rate (Per-protocol Analysis) | 72 hours | 37.82 breaths per minute |
| St-FMOT | Respiratory Rate (Per-protocol Analysis) | 4 hours | 51.81 breaths per minute |
| St-FMOT | Respiratory Rate (Per-protocol Analysis) | 96 hours | 36.63 breaths per minute |
| St-FMOT | Respiratory Rate (Per-protocol Analysis) | 24 hours | 44.23 breaths per minute |
| HFNCOT | Respiratory Rate (Per-protocol Analysis) | 96 hours | 35.37 breaths per minute |
| HFNCOT | Respiratory Rate (Per-protocol Analysis) | 24 hours | 40.47 breaths per minute |
| HFNCOT | Respiratory Rate (Per-protocol Analysis) | Baseline | 66.68 breaths per minute |
| HFNCOT | Respiratory Rate (Per-protocol Analysis) | 1 hour | 56.60 breaths per minute |
| HFNCOT | Respiratory Rate (Per-protocol Analysis) | 2 hours | 50.65 breaths per minute |
| HFNCOT | Respiratory Rate (Per-protocol Analysis) | 4 hours | 46.00 breaths per minute |
| HFNCOT | Respiratory Rate (Per-protocol Analysis) | 12 hours | 43.71 breaths per minute |
| HFNCOT | Respiratory Rate (Per-protocol Analysis) | 48 hours | 39.05 breaths per minute |
| HFNCOT | Respiratory Rate (Per-protocol Analysis) | 72 hours | 36.51 breaths per minute |
Comparison: The p-Value of the interaction between time and groups was given. In all analysis, p values \<0.05 were considered being statistically significant.p-value: 0.00395% CI: [-6.62, 1.78]Mixed Models Analysis
Secondary
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
Population: The population of the intention to treat.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| St-FMOT | Treatment Failure at 4 Hours (Intention-to-treat Analysis) | 10 Participants |
| HFNCOT | Treatment Failure at 4 Hours (Intention-to-treat Analysis) | 1 Participants |
p-value: 0.02Fisher Exact