Skip to content

High Flow Nasal Cannula therapy for infants with Bronchiolitis: a randomized controlled trial

High Flow Nasal Cannula therapy for infants with Bronchiolitis: a randomized controlled trial - High flow in bronchiolitis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON42950
Enrollment
118
Registered
2016-11-10
Start date
2016-12-01
Completion date
Unknown
Last updated
2024-04-23

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

Conditions

Bronchiolitis luchtweginfectie

Interventions

Standard mode of oxygen delivery (in the control group) is through dry gas at a limited flow rate 99% relative humidity) of oxygen and air mixtures, comfortable oxygen delivery is allowed at flow ra

Sponsors

Isala Klinieken
Lead Sponsor

Eligibility

Age
2 Years to 11 Years

Inclusion criteria

Inclusion criteria: Patients

Exclusion criteria

Exclusion criteria: Bronchopulmonary dysplasia Congenital heart disease Congenital pulmonary abnormalities Syndromal disease (for example trisomie 21)

Design outcomes

Primary

MeasureTime frame
Decrease in dyspnoea severity, depicted by decrease in PEWS with >= 2 points within 24 hours. PEWS will be assessed at t=0, 1, 2 and 3 hours and thereafter at least every three hours during hospitalisation, or more frequent, as indicated.

Secondary

MeasureTime frame
Respiratory rate, retractions, heart rate, conscious state, oxygen saturation, FiO2, temperature, Comfort (FLACC), ability to feed, tube feeding, intravenous fluids, bloodgas analysis (in case of PEWS >= 8, or as indicated by the treating physician), mechanical ventilation, referral to PICU, length of hospitalization. By measuring these different variables we are able to compose several composite dyspnoea scores other than the PEWS (i.e. RDAI Respiratory Distress Assessment Instrument, PRAM Pediatric Respiratory Assessment Measurement). None of these scores is sufficiently validated, however by measuring the most frequently used, we will enable comparison of our data with other studies.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)