Assesment of the Effectiveness of High Frequency Oral Oscillation and Mask of PEP in Children With Pneumonia

NCT02192268 | Unknown DMC

• 1 other identifier: PEP/HFOO
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The hypothesis of this study is that the physiologic effects of these (PEP/ HFOO) resources may have positive effects in this population of children with acute respiratory illness. Thinking about this physical and physiological issue and due to the absence of a study that has evaluated the effectiveness of these instruments in patients with pneumonia, the objective of this study is to evaluate the short-term effects OOAF and mask of EPAP in children hospitalized for community-acquired pneumonia.

Conditions

Pneumonia

Outcome Measures

Primary Outcomes (1)

• Change in Severity Score

  Will be assigned a severity score proposed based on other studies with clinical variables and diagnostic criteria. This score will vary from 0 to 18 points. Participants will be followed for the duration of hospital stay, an expected average of 4 or 5 days.

  Change from Baseline Severity score at 4 days

Secondary Outcomes (1)

• Change in Peak Flow meter

  Change from Baseline peak flow at 4 days

Study Arms (3)

HFOO

ACTIVE COMPARATOR

Children of the HFOO group will be subjected to two daily sessions of this resource which should be the same throughout her hospitalization with Shaker equipment.

Other: HFOO

Assisted Coughing

ACTIVE COMPARATOR

The children in the control group will be subjected to two daily sessions of assisted coughing.

Other: Assisted Coughing

PEP

ACTIVE COMPARATOR

The children will be subjected to PEP group two daily sessions of this resource which should be the same throughout her hospitalization with facial mask and valve Spring load with expiratory pressure of 10cmH2O.

Other: PEP

Interventions

PEP OTHER

PEP

HFOO OTHER

HFOO

Assisted Coughing OTHER

Assisted Coughing

Eligibility Criteria

• Age: 3 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• age between 03 and 11 years old;
• have Pneumonia diagnosis done by a physician pediatrician (1) presence of cough and/or fever; (2) tachypnea according to age group (1-5 years-40 bpm; 5 years -30 bpm); (3) radiological change with consolidation or infiltrators associated or not with other findings compatible with pneumonia. All films will be evaluated by a radiologist and a pediatrician

You may not qualify if:

• chronic neurological Disease, or respiratory arrest
• failure to collaborate with therapy or assessment
• need of invasive or non-invasive ventilatory assistance
• hemodynamic instability
• vomiting or nausea
• not drained Pneumothorax
• not drained extensive pleural effusion
• dyspnea
• do not agree with research

Sponsors & Collaborators

• Hospital Sirio-Libanes: lead
• University of Nove de Julho: collaborator
• Hospital e maternidade São Luiz: collaborator

Study Sites (1)

Hospital são Luiz Jabaquara

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Evelim FD Gomes, PhD

  University of Nove de Julho

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Evelim LFD Gomes, PhD

CONTACT

551136242572; evelimfreitas@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: July 11, 2014
• First Posted: July 16, 2014
• Study Start: August 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: January 1, 2018
• Last Updated: February 24, 2017

Record last verified: 2017-02

Locations

BR (1)