Clinical trial NCT04245202: Comparison of High Flow Nasal Cannula and Standard Face Mask Oxygen Therapy in Children With Bronchiolitis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Bronchiolitis
Keywords: Acute Bronchiolitis
High Flow Nasal Cannula
Standard Face Mask
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2020-01-28
Enrollment: 87
Sex: ALL
Minimum age (years): 1
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time Taken to Reach the Normal Range for Heart Rate (Per-protocol Analysis)
timeFrame: through study completion, an average of 96 hours
measure: Time Taken to Reach the Normal Range for Respiratory Rate (Per-protocol Analysis)
timeFrame: through study completion, an average of 96 hours
measure: Time Taken to Regress A Lower Clinical Respiratory Score (Per-protocol Analysis)
timeFrame: through study completion, an average of 96 hours
Secondary outcomes:
measure: Heart Rate (Intention-to-treat Analysis)
timeFrame: Baseline, 1,2,4,12,24,48,72 and 96 hours
measure: Heart Rate (Per-protocol Analysis)
timeFrame: Baseline, 1,2,4,12,24,48,72 and 96 hours
measure: Respiratory Rate (Intention-to-treat Analysis)
timeFrame: Baseline, 1,2,4,12,24,48,72 and 96 hours
measure: Respiratory Rate (Per-protocol Analysis)
timeFrame: Baseline, 1,2,4,12,24,48,72 and 96 hours
measure: Clinical Respiratory Score (Intention-to-treat Analysis)
timeFrame: Baseline, 1,2,4,12,24,48,72 and 96 hours
measure: Clinical Respiratory Score (Per-protocol Analysis)
timeFrame: Baseline, 1,2,4,12,24,48,72 and 96 hours
measure: Oxygen Requirement (Intention-to-treat Analysis)
timeFrame: through study completion, an average of 168 hours
measure: Oxygen Requirement (Per-protocol Analysis)
timeFrame: through study completion, an average of 168 hours
measure: Length of Hospital Stay (Intention-to-treat Analysis)
timeFrame: through study completion, an average of 168 hours
measure: Length of Hospital Stay (Per-protocol Analysis)
timeFrame: through study completion, an average of 168 hours
measure: Treatment Failure at 4 Hours (Intention-to-treat Analysis)
timeFrame: 4 hours
measure: Pediatric Intensive Care Unit Admission (Intention-to-treat Analysis).
timeFrame: through study completion, an average of 168 hours
measure: Adverse Events of Therapy (Intention-to-treat Analysis)
timeFrame: through study completion, an average of 168 hours
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Ege University Medical Faculty
state: Select A State
Study officials:
affiliation: Ege University Medical Study
name: Aykut Eşki, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.