High Flow Nasal Cannula vs Low Flow Oxygen Therapy in Bronchiolitis

Bronchiolitis Clinical Trial

Official title:

Randomized Controlled Trial to Compare the Efficacy of High Flow Nasal Cannula Oxygen Therapy vs Low Flow Oxygen Therapy in Bronchiolitis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03015051
• Other study ID #: High flow RCT
• Status: Terminated
• Phase: Phase 4
• Start date: January 2017
• Est. completion date: December 2019

Study information

• Verified date: September 2020
• Source: IRCCS Burlo Garofolo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Bronchiolitis is the most common respiratory infection of the lower respiratory tract that affects 11-12% of infants in their first year of life. Approximately 1-2% of patients with bronchiolitis require hospital admission because of poor feeding and/or breathing difficulties. The standard treatment for bronchiolitis is represented by oxygen-therapy and hydration while neither steroids nor epinephrine nor bronchodilators are recommended. One of the techniques of administration of oxygen in bronchiolitis is represented by the high flow (HFNC) or by a system in which oxygen is delivered to 2L/kg through nasal cannulas. The HFNC provides humidification, heating and oxygen, ensuring a minimum positive pressure, reduces breathing load and allows for better nutrition. The main aim of therapy with high flows is to reduce the days of oxygen therapy and the cases of intubation. However, up to now, there have been few studies on the use of HFNC in Pediatric Emergency Units. The Cochrane review on this topic, updated in May 2013, included only one randomized controlled trial (RCT) on a pilot study of 19 subjects comparing HFNC with oxygen administered via "head box". The oxygen saturation was higher in children HFNC after 8 (00% versus 96%, p=0.04) and 12 hours (99% vs 96%, p=0.04) but similar in both groups at 24 hours. The authors concluded that the available evidence is insufficient to determine the effectiveness of HFNC.

The aim of this study is to evaluate in a large number of cases the effectiveness of treatment with high flow versus standard treatment, in children with bronchiolitis referred to a Pediatric Emergency Department.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Months

Eligibility

Inclusion Criteria:

• diagnosis of bronchiolitis

• age >28 days and <6 months

• Oxygen saturation (SaO2) <92%

• respiratory rate >60 breaths/min

• dyspnea with respiratory distress assessment instrument (RDAI) score =8

• daily milk or food intake less than 2/3 than normally assumed

Exclusion Criteria:

• chronic diseases or syndromes

• respiratory diseases (i.e. bronchopulmonary dysplasia)

• heart diseases

• preterm birth (before 36 weeks of gestational age)

Related Conditions & MeSH terms

• Bronchiolitis

Intervention

Drug:
• Oxygen

Locations

Country	Name	City	State
Italy	Ospedale Maggiore	Bologna	Emilia Romagna
Italy	Ospedale A. Cardarelli	Campobasso	Molise
Italy	Ospedale Morgagni-Pierantoni	Forlì	Emilia Romagna
Italy	Istituto G. Gaslini	Genova	Liguria
Italy	Ospedale Provinciale di Macerata	Macerata	Marche
Italy	Fondazione MBBM c/o Ospedale San Gerardo	Monza	Lombardia
Italy	Ospedale Giovanni Paolo II	Olbia	Sardegna
Italy	Azienda Ospedaliera di Padova	Padova	Veneto
Italy	Ospedale Santa Maria degli Angeli	Pordenone	Friuli Venezia Giulia
Italy	Ospedale Ravenna AUSL Romagna	Ravenna	Emilia Romagna
Italy	Ospedale Pediatrico IRCCS Bambino Gesú	Rome	Lazio
Italy	Ospedale Principe di Piemonte Area Vasta 2	Senigallia	Marche
Italy	Ospedale Infantile Regina Margherita	Torino	Piemonte
Italy	Pediatric Emergency Department, IRCCS Burlo Garofolo	Trieste	Friuli Venezia Giulia
Italy	Ospedale Castelli	Verbania	Piemonte

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Burlo Garofolo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hours of oxygen therapy		up to 5 days
Secondary	Number of subject admitted in intensive care unit		up to 5 days
Secondary	Number of patients needing intubation		up to 5 days
Secondary	Days of parenteral hydration or nasogastric enteral feeding	Number of days	up to 5 days
Secondary	Adverse events	Number and type. Frequency of possible complication such as pneumothorax, pneumomediastinum or atelectasis will be evaluated	up to 15 days