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ALI/ARDS in Oncologic Pediatric Patients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2013 by Rodrigo Genaro Arduini, Grupo de Apoio ao Adolescente e a Crianca com Cancer.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01304654
First Posted: February 25, 2011
Last Update Posted: March 14, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Rodrigo Genaro Arduini, Grupo de Apoio ao Adolescente e a Crianca com Cancer
  Purpose
Identify pediatric oncologic patients with ALI/ARDS at GRAACC/IOP's Pediatric Intensive Care Unit and evaluate the mechanical ventilation practice in these subjects for a 48mo period.

Condition
Acute Lung Injury Acute Respiratory Distress Syndrome Neoplasms

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Practice of Mechanical Ventilation in Pediatric Oncologic Patients Diagnosed With Acute Lung Injury / Acute Respiratory Distress Syndrome

Resource links provided by NLM:


Further study details as provided by Rodrigo Genaro Arduini, Grupo de Apoio ao Adolescente e a Crianca com Cancer:

Primary Outcome Measures:
  • Identify pediatric oncologic patients with ALI/ARDS at GRAACC's PICU and evaluate how they are mechanically ventilated [ Time Frame: 2y ]

Secondary Outcome Measures:
  • Epidemiologic data about the selected patients [ Time Frame: 28 days ]
    Type and data about their mechanical ventilation, etiologic factors for ALI/ARDS, mortality rates, predictive factors about outcomes (death/ discharge), necessity and types of rescue therapies (surfactant, prone position, corticosteroids, etc.)


Enrollment: 29
Study Start Date: January 2011
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
ALI/ARDS oncologic patients
Consecutively admitted patients at GRAACC's PICU with malignancy diagnosis according to IDC-10, in a 24mo consecutive period, under mechanical ventilation for over 24h and with ALI/ARDS criteria, not younger than 29 days or older than 17 years 11 months

Detailed Description:

Evaluate adequate mechanical ventilation based on protective ventilation protocols for children available so far.

Evaluate and describe the subjects. Evaluate the necessity and outcome of rescue therapies (surfactant, prone position, corticosteroids, alveolar recruitment) Obtain data about ALI/ARDS' etiology, mortality rates and predictive factors related to the outcomes (PICU/ hospital discharge or death)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pediatric oncologic patients
Criteria

Inclusion Criteria:

  • patients admitted at the intensive care unit with diagnosis of acute lung injury or acute respiratory distress syndrome and submitted to mechanical ventilation for over 24h

Exclusion Criteria:

  • mechanical ventilation less than 24h
  • absence of ALI/ARDS criteria
  • no neoplasm diagnosis
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01304654


Locations
Brazil
Grupo de Apoio ao Adolescente e à Criança com Câncer
Sao Paulo, Brazil, 04023-062
Sponsors and Collaborators
Grupo de Apoio ao Adolescente e a Crianca com Cancer
Investigators
Principal Investigator: Rodrigo G Arduini, MD Grupo de Apoio ao Adolescente e a Crianca com Cancer
  More Information

Responsible Party: Rodrigo Genaro Arduini, MD, Grupo de Apoio ao Adolescente e a Crianca com Cancer
ClinicalTrials.gov Identifier: NCT01304654     History of Changes
Other Study ID Numbers: UTI/IOP 02/11
0031/11 ( Other Identifier: CEP UNIFESP )
First Submitted: February 24, 2011
First Posted: February 25, 2011
Last Update Posted: March 14, 2013
Last Verified: March 2013

Keywords provided by Rodrigo Genaro Arduini, Grupo de Apoio ao Adolescente e a Crianca com Cancer:
acute lung injury
respiratory distress syndrome
neoplasms
child

Additional relevant MeSH terms:
Syndrome
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Injury
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Thoracic Injuries
Wounds and Injuries