NCT00884429

Brief Summary

The purpose of this study is to verify the effectiveness of chest physiotherapy (actual versus conventional) on respiratory distress in infants with acute viral bronchiolitis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

April 17, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 20, 2009

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

August 30, 2012

Status Verified

January 1, 2012

Enrollment Period

1 year

First QC Date

April 17, 2009

Last Update Submit

August 28, 2012

Conditions

Keywords

Chest physiotherapy

Outcome Measures

Primary Outcomes (1)

  • Respiratory distress

    This outcome was evaluated with Wang's score for infants with bronchiolitis

    on first evaluation by physiotherapyst ( until 2 hours after hospital admission)

Secondary Outcomes (3)

  • Respiratory distress

    48 hours after first evaluation

  • Respiratory distress

    72 hours after first evaluation

  • Respiratory distress

    1 hour before hospital discharge

Study Arms (3)

1- Conventional Chest Physiotherapy

ACTIVE COMPARATOR

Percussion , thorax compression and Postural Drainage/suction if necessary

Procedure: Chest physiotherapy - Conventional

2- Chest physiotherapy- Actual techniques

ACTIVE COMPARATOR

slow prolonged expiration and clearance rhinopharynx and suction if necessary

Procedure: Chest physiotherapy - actual techniques

3- Airway Suction

ACTIVE COMPARATOR

Suction superior airways. Only in admission.

Procedure: 3-Airway suction

Interventions

Percussion Postural Drainage and thorax compression

1- Conventional Chest Physiotherapy

Slow prolonged expiration and clearance rhinopharynx retrograde

2- Chest physiotherapy- Actual techniques

Airway suction

3- Airway Suction

Eligibility Criteria

Age28 Days - 24 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Clinical diagnosis of acute viral bronchiolitis
  • RSV positive

You may not qualify if:

  • Heart diseases
  • Chronic lung disease
  • Neurological diseases
  • Parental refusal
  • Previous wheezing episode
  • ventilatory support

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Sírio Libanês

São Paulo, São Paulo, 01308-050, Brazil

Location

Related Publications (2)

  • Roque-Figuls M, Gine-Garriga M, Granados Rugeles C, Perrotta C, Vilaro J. Chest physiotherapy for acute bronchiolitis in paediatric patients between 0 and 24 months old. Cochrane Database Syst Rev. 2023 Apr 3;4(4):CD004873. doi: 10.1002/14651858.CD004873.pub6.

  • Gomes EL, Postiaux G, Medeiros DR, Monteiro KK, Sampaio LM, Costa D. Chest physical therapy is effective in reducing the clinical score in bronchiolitis: randomized controlled trial. Rev Bras Fisioter. 2012 Jun;16(3):241-7. doi: 10.1590/s1413-35552012005000018. Epub 2012 Apr 12.

MeSH Terms

Conditions

Bronchiolitis, Viral

Condition Hierarchy (Ancestors)

BronchiolitisBronchitisRespiratory Tract InfectionsInfectionsVirus DiseasesBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung Diseases

Study Officials

  • Evelim LF Dantas Gomes, Master

    Hospital Sírio Libanês e UNINOVE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master in Science Rehabilitation

Study Record Dates

First Submitted

April 17, 2009

First Posted

April 20, 2009

Study Start

April 1, 2009

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

August 30, 2012

Record last verified: 2012-01

Locations