Viral respiratory distress in infants < 6 months treated with high or low fluxes of oxygen

Randomized controlled trial to evaluate the efficacy of high flow versus low flow oxygen therapy in bronchiolitis - High or low fluxes of Oxygen in Bronchiolitis

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-003093-32-IT

Enrollment

130

Registered

2016-01-14

Start date

2016-06-15

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchiolitis MedDRA version: 18.1 Level: PT Classification code 10006448 Term: Bronchiolitis System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: OSSIGENO AIR LIQUIDE SANITÀ 200 BAR GAS MEDICINALE COMPRESSO Product Name: OSSIGENO AIR LIQUIDE SANITÀ 200 BAR GAS MEDICINALE COMPRESSO Pharmaceutical Form: Inhalation solution Trade Name

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Subjects diagnosed with bronchiolitis who present at the Emergency Departments with the following inclusion criteria: • Diagnosis of bronchiolitis • Age 60 breaths / min • severe dyspnea (RDAI score =8) Are the trial subjects under 18? yes Number of subjects for this age range: 130 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Exclusion criteria will be the presence of: • syndromes and chronic diseases • respiratory diseases (eg. Broncodisplasie) • heart disease • preterm birth (patients born before 36 weeks of gestational age)

Design outcomes

Primary

Measure	Time frame
Primary end point(s): Primary endpoint of the study is the time (measured in hours) of oxygen from its beginning to the suspension related to clinical improvement, defined as persistent for at least 3 hours in the air environment SaO2> 92% associated with respiratory and heart rate within the 90th percentile by age. Therefore, since the start of oxygen every two hours in the first six hours and then every 6 hours until the suspension of oxygen, the vital signs of the children enrolled will be assessed, trying to lower the administration of gas (l / minute or FI02) so to obtain a saturation> 92% with the lowest possible concentration of oxygen, up to a complete suspension.;Timepoint(s) of evaluation of this end point: 3 days;Main Objective: Evaluate the effectiveness of treatment with high flow than the standard in children with bronchiolitis admitted to a pediatric emergency department.;Secondary Objective: Not applicable	—

Measure

Time frame

Primary end point(s): Primary endpoint of the study is the time (measured in hours) of oxygen from its beginning to the suspension related to clinical improvement, defined as persistent for at least 3 hours in the air environment SaO2> 92% associated with respiratory and heart rate within the 90th percentile by age. Therefore, since the start of oxygen every two hours in the first six hours and then every 6 hours until the suspension of oxygen, the vital signs of the children enrolled will be assessed, trying to lower the administration of gas (l / minute or FI02) so to obtain a saturation> 92% with the lowest possible concentration of oxygen, up to a complete suspension.;Timepoint(s) of evaluation of this end point: 3 days;Main Objective: Evaluate the effectiveness of treatment with high flow than the standard in children with bronchiolitis admitted to a pediatric emergency department.;Secondary Objective: Not applicable

—

Secondary

Measure	Time frame
Secondary end point(s): Secondary endpoints: or the number of patients referred to intensive care or number of patients intubated; or the number and type of complications; or number of days of parenteral hydration or nutrition through a nasogastric tube.;Timepoint(s) of evaluation of this end point: 7 days	—

Countries

Italy

Contacts

Public ContactDr. Alessandra Maestro

IRCCS Burlo Garofolo

alessandra.maestro@burlo.trieste.it00390403785418

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026