Mucociliary Clearance Techniques for Acute Bronchiolitis

NCT ID: NCT06689631

Last Updated: 2024-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-01

Study Completion Date

2025-05-31

Brief Summary

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

Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment group

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.

Group Type EXPERIMENTAL

Respiratory Physiotherapy

Intervention Type PROCEDURE

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

Interventions

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Respiratory Physiotherapy

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

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

28 Days

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad de León

OTHER

Sponsor Role lead

Responsible Party

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Raquel Leirós-Rodríguez

Principal investigator and Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Raquel Leirós-Rodríguez, PhD.

Role: CONTACT

+34 987 44 20 00

References

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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.

Reference Type BACKGROUND
PMID: 34625378 (View on PubMed)

Other Identifiers

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ULE

Identifier Type: OTHER

Identifier Source: secondary_id

ETICA-ULE-062-2023

Identifier Type: -

Identifier Source: org_study_id

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