NCT01017081

Brief Summary

Chest physiotherapy has been used to treat pediatric patients hospitalized with pneumonia however there was no evidence to support a beneficial effect in pediatric patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2001

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

September 1, 2001

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2002

Completed
7.2 years until next milestone

First Submitted

Initial submission to the registry

November 19, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 20, 2009

Completed
Last Updated

November 20, 2009

Status Verified

November 1, 2009

Enrollment Period

1 year

First QC Date

November 19, 2009

Last Update Submit

November 19, 2009

Conditions

Keywords

physiotherapychildrenclinical trial

Study Arms (2)

Control

ACTIVE COMPARATOR

Non-mandatory request to maintain lateral positioning to improve air exchange, to cough in order to clear secretion, and to perform diaphragmatic and deep breathing, for five minutes, once a day, during hospital stay.

Other: Positioning and cough

Physiotherapy

EXPERIMENTAL

Physiotherapy: Children younger than 5 years: Manual Thoracic vibration (TV), thoracic compression (TC), positive expiratory pressure (PEP), and forced exhalation with the glottis open ("huffing"). Children aged 5 years or older: same procedures in addition to the ventilatory patterns, and a forced expiratory technique (FET), consisting of one or two "huffs" (forced expirations) followed by a period of relaxed, controlled diaphragmatic breathing, three times per day, for 10 to 12 minutes, during hospital admission.

Other: Physiotherapy

Interventions

Physiotherapy: three times per day, for 10 to 12 minutes, during hospital admission

Physiotherapy

Non-mandatory request to maintain lateral positioning to improve air exchange and cough

Control

Eligibility Criteria

Age1 Year - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 1 to 12 years with acute community-acquired pneumonia (cough, tachypnea, fever and with a chest radiography with lobar, segmental or bronchopneumonia within the first 48 hours)

You may not qualify if:

  • Severely ill patients (hospitalized in intensive care units)
  • Pleural effusion treated with chest drainage
  • Atelectasis detected by x-ray
  • Pneumonia or pleural effusion in the previous six months
  • Other pulmonary underlying disease, heart disease, cerebral palsy or immune deficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Santa Casa de Porto Alegre

Posto Alegre, Rio Grande do Sul, 90020-160, Brazil

Location

MeSH Terms

Conditions

Pneumonia

Interventions

Physical Therapy ModalitiesPatient Positioning

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitationPatient CareHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 19, 2009

First Posted

November 20, 2009

Study Start

September 1, 2001

Primary Completion

September 1, 2002

Study Completion

September 1, 2002

Last Updated

November 20, 2009

Record last verified: 2009-11

Locations