Work of Breathing in Nasal CPAP Versus High Flow Nasal Prong in Infants With Severe Acute Bronchiolitis

Bronchiolitis Clinical Trial

Official title:

Work of Breathing in Nasal CPAP Versus High Flow Nasal Prong in Infants With Severe Acute Bronchiolitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01944995
• Other study ID #: 2012-A01524-39
• Secondary ID: 2012-36
• Status: Recruiting
• Phase: N/A
• First received: September 13, 2013
• Last updated: August 27, 2014
• Start date: September 2013
• Est. completion date: September 2015

Study information

• Verified date: August 2014
• Source: Assistance Publique Hopitaux De Marseille
• Contact: fabrice michel
• Email: fabrice.michel[@]ap-hm.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

Nasal continuous positive airway pressure (nCPAP), widely used in neonatal intensive care is also more and more used in infants with severe acute bronchiolitis. There is no evidence that nCPAP improves outcome, but several studies showed that it reduces work of breathing (WOB), improves gas exchange and decreases intubation rate. High flow nasal prong (HFNP) therapy, also used in neonatal units, has recently been suggested for bronchiolitis management. This technique allows warmed and moist gas administration protecting nasal mucosa, and preventing variations of inspired gas FiO2. HFNP also creates a continuous positive pressure, reducing WOB, and seems much more comfortable and better tolerated by babies than nCPAP. There are no studies comparing both techniques for bronchiolitis management. The main objective of this study is to compare WOB with nCPAP and HFNP therapy in infants with severe bronchiolitis in pediatric intensive care unit. Secondary purpose is to compare efficacy and tolerance of both techniques. We propose to lead an open, single center, crossover randomized study. Each patient will receive the two treatments. Three consecutive periods will be studied: first one (minimum 2 hours), with the first technique CPAP or HFNP according to randomization (treatment 1); second period (2 hours) with the second technique (treatment 2); Third period (6 hours) with the second technique. The primary endpoint will be the comparison of WOB (estimated by the calculation of the transdiaphragmatic pressure-time product) at the end of the two firsts periods. Efficacy and tolerance of each technique will be evaluated and compared by compared measuring respiratory rate, heart rate, FiO2, SpO2, transcutaneous PCO2, modified Wood score, and EDIN score during the third period. Nine subjects by groups are required.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: September 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 3 Months

Eligibility

Inclusion Criteria:

• Infants less than 3 months

• Infants hospitalized in the pediatric intensive care unit of the hospital in northern Marseille for an episode of acute viral bronchiolitis, defined by the French consensus conference of 2000 (1) clinical signs of infection of the upper airways with tachypnea, brake expiratory and / or wheezing auscultation, signs of struggle

• Infants with acute respiratory distress score with Wood changed> 3 and requiring ventilatory Support

• Infants whose parents or legal guardians have accepted their participation in the research and signed informed consent.

• With Social Security

Exclusion Criteria:

• - Clinical condition requiring immediate intubation before the start of treatment to the:

• severity of respiratory distress: FiO2> 60% to maintain SpO2> 92%

• hemodynamic instability

• the occurrence of apneas désaturantes (respiratory pauses greater than 20 seconds duration associated with desaturation <80% and / or bradycardia <80/min)

• the presence of neurological disorders with altered consciousness

• Presence of co-morbidities:

• chronic respiratory failure

• heart

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Bronchiolitis

Intervention

Device:
• glasses broadband

• nasal CPAP

Locations

Country	Name	City	State
France	Assistance Publique Hopitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	calculation of the trans-diaphragmatic pressure		12 months	No
Secondary	the effectiveness of treatments	respiratory and hemodynamic parameters: ( Respiratory rate; Heart Rate; blood pressure; Clinical signs of struggle); haematosis ( SpO2 ; FiO2 ; transcutaneous PCO2 )	12 months	No