Mucociliary Clearance Techniques for Acute Bronchiolitis

NCT06689631 | Not Yet Recruiting DMC

• 2 other identifiers: ETICA-ULE-062-2023ULE
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

To assess the efficacy of mucociliary clearance techniques in non-hospitalised infants with a first episode of mild to moderate acute bronchiolitis.

Conditions

Acute Bronchiolitis Due to Respiratory Syncytial Virus; Bronchiolitis Acute; Bronchiolitis Acute Viral

Keywords

mucociliary clearance; respiratory physiotherapy

Outcome Measures

Primary Outcomes (1)

• ESBA

  The variables collected using the ESBA scale were: wheezing, crackles, inspiratory effort, Inspiratory/Expiratory ratio, respiratory rate and heart rate.

  1 session (45 minutes)

Study Arms (1)

Treatment group

EXPERIMENTAL

The intervention consisted of a Respiratory Physiotherapy session including: mucociliary clearance techniques (prolonged slow expiration and provoked cough), bronchodilator when prescribed and nebulisation with 3% hypertonic saline.

Procedure: Respiratory Physiotherapy

Interventions

Respiratory Physiotherapy PROCEDURE

Mucociliary clearance techniques (prolonged slow expiration and provoked cough), bronchodilator when prescribed and nebulisation with 3% hypertonic saline.

Treatment group

Eligibility Criteria

• Age: 28 Days - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Medical diagnosis of first episode of acute Bronchiolitis.
• Acute Bronchiolitis with mild (ESBA score = 1-4) or moderate (ESBA score =5-9) severity according to the ESBA.
• Informed consent signed by parents or legal guardians.

You may not qualify if:

• Infants previously diagnosed with chronic respiratory disease.
• Previous episodes of wheezing.
• Presence of any type of contraindication to receive Respiratory Physiotherapy treatment.

Sponsors & Collaborators

• Universidad de León: lead

Related Publications (1)

• Gonzalez Bellido V, Velaz Baza V, Esteo MDCJ, Carballo RG, Colombo A, Zaldivar JNC, Donadio MVF. Safety of airway clearance combined with bronchodilator and hypertonic saline in non-hospitalized infants with acute bronchiolitis. Arch Pediatr. 2021 Nov;28(8):707-711. doi: 10.1016/j.arcped.2021.09.007. Epub 2021 Oct 5.

  PMID: 34625378 BACKGROUND

Central Study Contacts

Raquel Leirós-Rodríguez, PhD.

CONTACT

+34 987 44 20 00; rleir@unileon.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator and Associate Professor

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: November 14, 2024
• Study Start: December 1, 2024
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: November 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share