ALI/ARDS in Oncologic Pediatric Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Rodrigo Genaro Arduini, Grupo de Apoio ao Adolescente e a Crianca com Cancer
ClinicalTrials.gov Identifier:
NCT01304654
First received: February 24, 2011
Last updated: March 13, 2013
Last verified: March 2013

February 24, 2011
March 13, 2013
January 2011
March 2013   (final data collection date for primary outcome measure)
Identify pediatric oncologic patients with ALI/ARDS at GRAACC's PICU and evaluate how they are mechanically ventilated [ Time Frame: 2y ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT01304654 on ClinicalTrials.gov Archive Site
Epidemiologic data about the selected patients [ Time Frame: 28 days ] [ Designated as safety issue: No ]
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.)
Not Provided
Not Provided
Not Provided
 
ALI/ARDS in Oncologic Pediatric Patients
Practice of Mechanical Ventilation in Pediatric Oncologic Patients Diagnosed With Acute Lung Injury / Acute Respiratory Distress Syndrome

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.

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)

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
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Non-Probability Sample

Pediatric oncologic patients

  • Acute Lung Injury
  • Acute Respiratory Distress Syndrome
  • Neoplasms
Not Provided
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
29
Not Provided
March 2013   (final data collection date for primary outcome measure)

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
Both
up to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01304654
UTI/IOP 02/11, 0031/11
No
Rodrigo Genaro Arduini, Grupo de Apoio ao Adolescente e a Crianca com Cancer
Grupo de Apoio ao Adolescente e a Crianca com Cancer
Not Provided
Principal Investigator: Rodrigo G Arduini, MD Grupo de Apoio ao Adolescente e a Crianca com Cancer
Grupo de Apoio ao Adolescente e a Crianca com Cancer
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP