HFNC Versus NCPAP/ NPPV in Infants With Severe Bronchiolitis

NCT04650230 | Completed

• 1 other identifier: RPP1
• Study Type: interventional
• Target: 268
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the study was to test the null hypothesis that there is no difference between nasal continuous positive airway pressure / nasal positive pressure ventilation (NCPAP/NPPV) and high flow nasal cannula (HFNC) devices when applied as a first non-invasive respiratory support mode for severe bronchiolitis

Conditions

Bronchiolitis

Outcome Measures

Primary Outcomes (2)

• Number of participants with HFNC success

  success was defined by no need of another respiratory support device

  during hospitalization, approximatly 6 days

• Number of participants with CPAP/NPPV success

  success was defined by no need of another support device

  during hospitalization, approximatly 6 days

Secondary Outcomes (1)

• rate of intubation

  during hospitalization, approximatly 6 days

Study Arms (2)

high flow nasal cannula (HFNC)

ACTIVE COMPARATOR

Participants in the HFNC group received heated and humidified gas flow with the Fisher \& Paykel Healthcare HFNC system. The flow rate was usually started at the maximum flow rate for the size of cannula and a constant flow temperature of 37 °C.The flow rate will be progressively decreased when inspired fraction of oxygen (FiO2) was inferior to 30 percent (%).

Device: nasal continuous positive airway pressure / nasal positive pressure ventilation (NCPAP/NPPV) and high flow nasal cannula (HFNC) devices

nasal continuous positive airway pressure / nasal positive pressure ventilation (NCPAP/NPPV)

ACTIVE COMPARATOR

Participants in the CPAP/NPPV group received for first CPAP using a neonatal ventilator. The recommended starting pressure for CPAP was +6 centimeter of water (cmH2O). Positive continuous pressure could be increased to a maximum of +8 cmH2O. Optimal positive end expiratory pressure (PEEP) was what could maintain SpO2 at 94 per cent using the lowest fraction of inspired oxygen. PEEP will be decreased progressively of 1cmH2O every 6 hours from the optimal PEEP when FiO2 was inferior to 30% and there is no increase of work of breath.

Device: nasal continuous positive airway pressure / nasal positive pressure ventilation (NCPAP/NPPV) and high flow nasal cannula (HFNC) devices

Interventions

nasal continuous positive airway pressure / nasal positive pressure ventilation (NCPAP/NPPV) and high flow nasal cannula (HFNC) devices DEVICE

high flow nasal cannula (HFNC); nasal continuous positive airway pressure / nasal positive pressure ventilation (NCPAP/NPPV)

Eligibility Criteria

• Age: 7 Days - 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Clinical diagnosis of bronchiolitis defined as the first viral episode of respiratory distress before 2 years of aging, presenting with rhinitis, tachypnea, cough, wheezing, prolonged expiratory time, crackles and use of accessory muscles, with or without fever, with or without infiltrate on the chest X ray
• bronchiolitis severity Wang modified score ≥ 10

You may not qualify if:

• recurrent wheezing
• heart disease
• chronic lung disease
• neuromuscular disease
• primary diagnosis was not bronchiolitis (pneumonia, pertussis)
• critically ill infants who had an immediate need of intubation

Sponsors & Collaborators

• Children's Hospital of Tunis: lead

MeSH Terms

Conditions

Bronchiolitis

Interventions

Continuous Positive Airway Pressure; Equipment and Supplies

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 25, 2020
• First Posted: December 2, 2020
• Study Start: December 1, 2013
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share