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
  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 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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.)


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

Ages Eligible for Study:   up to 17 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: February 24, 2011
Last Updated: March 13, 2013
Health Authority: Brazil: Ethics Committee

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

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

ClinicalTrials.gov processed this record on October 20, 2014