Acute BronchiolitisNCT04245202

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

A study testing HFNCOT and St-FMOT in people with Acute Bronchiolitis, run by Ege University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 1 month to 24 months
Conditions the study is for: Acute Bronchiolitis
What is being tested?: HFNCOT and St-FMOT
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 87 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 14 Mar 2017to 10 Mar 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 1 month to 24 months
All sexes
No healthy volunteers
Child

Who may be able to join

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%.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Ege University Medical Faculty
Izmir, Select A State, 35100

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of High Flow Nasal Cannula and Standard Face Mask Oxygen Therapy in Children With Moderate and Severe Bronchiolitis; a Randomized Controlled Trial

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: Acute Bronchiolitis
Being tested: HFNCOT, St-FMOT
Keywords: Acute Bronchiolitis, High Flow Nasal Cannula, Standard Face Mask

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HFNCOTDevice
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%.
St-FMOTOther
The inspired fraction of oxygen (FiO2) will be adjusted to obtain the oxygen saturation >92%.

Study groups in NCT04245202
Study group	Role	What they receive
Active Comparator: HFNCOT	Active comparator	Set between 2 to 25 l/min, adjusted to obtain peripheral oxygen saturation >92%. Receives: Device: HFNCOT
Active Comparator: St-FMOT	Active comparator	To obtain oxygen saturation >92% Receives: Other: St-FMOT

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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).
Measured: 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.
Measured: through study completion, an average of 96 hours

Secondary outcomes (13)

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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: through study completion, an average of 168 hours
Oxygen Requirement (Per-protocol Analysis)
The total duration of oxygen therapy (Per-protocol analysis).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: through study completion, an average of 168 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Mar 201710 Mar 2020

First posted28 Jan 2020
Study start14 Mar 2017
Primary completion10 Mar 2020
Study completion10 Mar 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (13)Papers the sponsor has linked to this study.
Other trials for Acute BronchiolitisStudies of the same condition, open and under way.
More trials run by Ege UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 87 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04245202
Sponsor's protocol ID: 17-TIP-012
Status last verified: Feb 2021
First submitted: 23 Jan 2020
Last updated: 16 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of High Flow Nasal Cannula and Standard Face Mask Oxygen Therapy in Children With Moderate and Severe Bronchiolitis; a Randomized Controlled Trial
ClinicalTrials.gov ID: NCT04245202
Acronym / sponsor ID: 17-TIP-012
Conditions: Acute Bronchiolitis
Keywords: Acute Bronchiolitis, High Flow Nasal Cannula, Standard Face Mask
Study type: Interventional
Recruitment status: Completed
Enrolment: 87 participants (actual)
Lead sponsor: Ege UniversityUniversity, hospital or other
Study start: 14 Mar 2017 (actual)
Primary completion: 10 Mar 2020 (actual)
Study completion: 10 Mar 2020 (actual)
First posted: 28 Jan 2020 (actual)
Results: Posted 16 Feb 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Active Comparator: HFNCOT	Active comparator	Device: HFNCOTSet between 2 to 25 l/min, adjusted to obtain peripheral oxygen saturation >92%.
Active Comparator: St-FMOT	Active comparator	Other: St-FMOTTo obtain oxygen saturation >92%

Who may qualify

Ages: 1 month to 24 months
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

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%.

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
HFNCOTThe 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%.	Device	Active Comparator: HFNCOT
St-FMOTThe inspired fraction of oxygen (FiO2) will be adjusted to obtain the oxygen saturation >92%.	Other	Active Comparator: St-FMOT

Primary outcome

Time Taken to Reach the Normal Range for Heart Rate (Per-protocol Analysis)
Time frame: 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)
Time frame: 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)
Time frame: 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.

13 secondary outcomes

Heart Rate (Intention-to-treat Analysis)
Time frame: Baseline, 1,2,4,12,24,48,72 and 96 hours
Heart Rate (Per-protocol Analysis)
Time frame: Baseline, 1,2,4,12,24,48,72 and 96 hours
Respiratory Rate (Intention-to-treat Analysis)
Time frame: Baseline, 1,2,4,12,24,48,72 and 96 hours
Respiratory Rate (Per-protocol Analysis)
Time frame: Baseline, 1,2,4,12,24,48,72 and 96 hours
Clinical Respiratory Score (Intention-to-treat Analysis)
Time frame: Baseline, 1,2,4,12,24,48,72 and 96 hours
Clinical Respiratory Score (Per-protocol Analysis)
Time frame: Baseline, 1,2,4,12,24,48,72 and 96 hours
Oxygen Requirement (Intention-to-treat Analysis)
Time frame: through study completion, an average of 168 hours
Oxygen Requirement (Per-protocol Analysis)
Time frame: through study completion, an average of 168 hours
Length of Hospital Stay (Intention-to-treat Analysis)
Time frame: through study completion, an average of 168 hours
Length of Hospital Stay (Per-protocol Analysis)
Time frame: through study completion, an average of 168 hours
Treatment Failure at 4 Hours (Intention-to-treat Analysis)
Time frame: 4 hours
Pediatric Intensive Care Unit Admission (Intention-to-treat Analysis).
Time frame: through study completion, an average of 168 hours
Adverse Events of Therapy (Intention-to-treat Analysis)
Time frame: through study completion, an average of 168 hours

Results and safety

Results posted to the registry on 16 Feb 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
St-FMOT	48	38
HFNCOT	39	38

Primary outcome: Time Taken to Reach the Normal Range for Heart Rate (Per-protocol Analysis)

Time frame: through study completion, an average of 96 hours. Median (Inter-Quartile Range). Unit: hour

Measure	St-FMOT n = 38	HFNCOT n = 38
Value	12 (2 to 24)	2 (1 to 4)

St-FMOT vs HFNCOT: p <0.001, Wilcoxon (Mann-Whitney)

Population analysed: The population of the per-protocol.

Primary outcome: Time Taken to Reach the Normal Range for Respiratory Rate (Per-protocol Analysis)

Time frame: through study completion, an average of 96 hours. Median (Inter-Quartile Range). Unit: hour

Measure	St-FMOT n = 38	HFNCOT n = 38
Value	24 (4 to 48)	4 (2 to 12)

St-FMOT vs HFNCOT: p <0.001, Wilcoxon (Mann-Whitney)

Population analysed: The population of the per-protocol.

Primary outcome: Time Taken to Regress A Lower Clinical Respiratory Score (Per-protocol Analysis)

Time frame: through study completion, an average of 96 hours. Median (Inter-Quartile Range). Unit: hour

Measure	St-FMOT n = 38	HFNCT n = 38
Value	4 (2 to 24)	2 (1 to 4)

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

Population analysed: The population of the per-protocol.

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected for 6 weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active Comparator: High-Flow Nasal Cannula Oxygen Therapy	0 of 39 (0%)	5 of 39 (12.8%)	0 of 39
Active Comparator: Standard Face Mask Oxygen Therapy	0 of 48 (0%)	1 of 48 (2.1%)	0 of 48

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 29562151Franklin 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.
Results publication: PubMed 26572729Franklin 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.
Results publication: PubMed 28353318Liu 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.
Results publication: PubMed 24846750Pham 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.
Results publication: PubMed 23900520Bressan 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.
Results publication: PubMed 30343318Milesi 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.
Results publication: PubMed 28903952Mace 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.
Results publication: PubMed 24912486Testa 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.
Results publication: PubMed 25593745Milesi 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.
Results publication: PubMed 27062623Schibler 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.
Results publication: PubMed 23809346Da 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.
Results publication: PubMed 24442856Beggs 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.

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Dental Cleaning to Prevent Chronic Graft-Versus-Host Disease
Chronic Graft Versus Host Disease, Acute Graft Versus Host Disease
RecruitingPhase 1
A Preliminary Clinical Study on the Efficacy of Cyclophosphamide and Sirolimus Combined With VIC-1911 in Preventing Graft-versus-Host Disease After Haploidentical Stem Cell Transplantation in Children
GVHD (Acute or Chronic)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Aykut Eşki, MD principal investigator

Ege University Medical Study

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing HFNCOT and St-FMOT in people with Acute Bronchiolitis, run by Ege University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time Taken to Reach the Normal Range for Heart Rate (Per-protocol Analysis) (time frame: through study completion, an average of 96 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04245202, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2021.