Bilevel Noninvasive Ventilation in Infants With Bronchiolitis Presenting With Apnea

NCT04408534 | Unknown DMC

• 1 other identifier: 2020-A01183-36
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

This physiological study aims to compare Bilevel Positive Airway Pressure and continuons positive airway pressure in infants with severe bronchiolitis presenting with apnea

Conditions

Bronchiolitis

Outcome Measures

Primary Outcomes (1)

• Apnea

  Number of apnea

  Up to 12 hours

Study Arms (2)

continuous positive airway pressure

ACTIVE COMPARATOR

Patients receive continuous positive airway pressure as a mode of noninvasive ventilation

Other: mode of noninvasive ventilation

bilevel positive airway pressure

EXPERIMENTAL

Patients receive bilevel positive airway pressure as a mode of noninvasive ventilation

Other: mode of noninvasive ventilation

Interventions

mode of noninvasive ventilation OTHER

administration of during 3 hours each 4 cycles

bilevel positive airway pressure; continuous positive airway pressure

Eligibility Criteria

• Age: 3 Days - 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children born at gestational age \> 36 weeks gestation
• Ventilated in Non Invasive Ventilation (NIV) for acute bronchiolitis (clinical criteria of the American Academy of Pediatrics)
• Having presented at least 1 apnea objectified by the parents or by a health care professional, as previously described (1), with one or more of the following characteristics: 1/Associated with bradycardia \< 80 / min, 2/Associated with desaturation \< 85% or 3/Duration more than 10 seconds
• Informed consent signed by at least one of the two parents + oral agreement from the second parent before the intervention of the study (2nd signature to be collected as soon as possible)

You may not qualify if:

• With chronic respiratory insufficiency requiring home ventilation (NIV or under long-term oxygen therapy, initiated at least 14 days before the start of the study)
• Hemodynamically significant cardiac disease, primary ENT or pulmonary pathology (malformative or genetic) or neuromuscular pathology
• Presenting a contraindication of a gastric tube (trauma or recent surgery concerning the cervical, pharyngeal or esophageal regions, severe coagulation disorders)
• Patient not affiliated to health care insurance

Sponsors & Collaborators

• University Hospital, Grenoble: lead

MeSH Terms

Conditions

Bronchiolitis

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2020
• First Posted: May 29, 2020
• Study Start: December 1, 2020
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: May 29, 2020

Record last verified: 2020-04