Safety of Airway Clearance in Non-hospitalized Infants With Acute Viral Bronchiolitis

NCT03835858 | Completed DMC

• 1 other identifier: 6.0
• Study Type: interventional
• Target: 265
• Locations: 1 country
• Sites: 1

Brief Summary

Bronchiolitis is a disease that can occur in a mild form and moderate, and often does not require hospitalization. The technique of prolonged slow expiration followed by cough caused in children not hospitalized with mild and moderate bronchiolitis can improve clinical severity

Conditions

Bronchiolitis

Keywords

Physical Therapy; Respiratory; Pediatric

Outcome Measures

Primary Outcomes (1)

• Wang clinical severity scale

  The clinical severity scale of Wang evaluates the respiratory rate, the presence of wheezing and intercostal retraction, and the patient's general condition, puncturing each dimension from 0 (the possible state) to 3 (values within normal), in addition to offer different cut points for children with more or less than 6 months.

  12 weeks

Secondary Outcomes (1)

• Oxygen saturation

  12 weeks

Study Arms (1)

Respiratory physiotherapy

OTHER

The protocol consists of 20 minutes of FR based on nasal washes in sitting, prolonged slow expiration: passive technique of expiratory help applied to the baby through a slow thoracic-abdominal pressure that begins at the end of a spontaneous expiration and continuing to the residual volume. The physiotherapist through the the provoked cough or stimulation of the trachea achieves the expectoration of the sputum.

Other: Respiratory physiotherapy

Interventions

Respiratory physiotherapy OTHER

The protocol consists of 20 minutes of FR based on nasal washes in sitting, prolonged slow expiration: passive technique of expiratory help applied to the baby through a slow thoracic-abdominal pressure that begins at the end of a spontaneous expiration and continuing to the residual volume. The physiotherapist through the the provoked cough or stimulation of the trachea achieves the expectoration of the sputum.

Respiratory physiotherapy

Eligibility Criteria

• Age: 2 Months - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Have an age between 2 months and 12 months.
• Have medical diagnosis of first episode of BQ of maximum 48 hours of evolution.
• Not previously received respiratory physiotherapy since its diagnosis.
• Have the informed consent signed by the child's legal guardians.

You may not qualify if:

• Acute BQ with score\> 9 according to the Wang clinical scale.
• Pathology associated cardiac, neurological or traumatic.
• Previous hospitalizations for wheezing.
• Medical diagnosis of recurrent sibilant.

Sponsors & Collaborators

• Guadarrama Hospital: lead
• Fisiobronquial Clínicas: collaborator

Study Sites (1)

J.Nicolas Cuenca Zaldivar

Guadarrama, Madrid, 28440, Spain

Location

MeSH Terms

Conditions

Bronchiolitis

Condition Hierarchy (Ancestors)

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

Study Officials

• J. Nicolas Cuenca Zaldivar

  Guadarrama Hospital

  PRINCIPAL INVESTIGATOR

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: Rehabilitation Service Principal Investigator

Model Details: Prospective, quasi-experimental study

Study Record Dates

• First Submitted: February 7, 2019
• First Posted: February 11, 2019
• Study Start: March 1, 2019
• Primary Completion: May 5, 2019
• Study Completion: May 5, 2019
• Last Updated: May 13, 2020

Record last verified: 2020-05

Locations

ES (1)