ALI/ARDS in Oncologic Pediatric Patients

Neoplasms Clinical Trial

Official title:

Practice of Mechanical Ventilation in Pediatric Oncologic Patients Diagnosed With Acute Lung Injury / Acute Respiratory Distress Syndrome

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01304654
• Other study ID #: UTI/IOP 02/11
• Secondary ID: 0031/11
• Status: Active, not recruiting
• Phase: N/A
• First received: February 24, 2011
• Last updated: March 13, 2013
• Start date: January 2011

Study information

• Verified date: March 2013
• Source: Grupo de Apoio ao Adolescente e a Crianca com Cancer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 29
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 17 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Lung Injury
• Neoplasms
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Locations

Country	Name	City	State
Brazil	Grupo de Apoio ao Adolescente e à Criança com Câncer	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Grupo de Apoio ao Adolescente e a Crianca com Cancer

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identify pediatric oncologic patients with ALI/ARDS at GRAACC's PICU and evaluate how they are mechanically ventilated		2y	No
Secondary	Epidemiologic data about the selected patients	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.)	28 days	No