ALI (Acute Lung Injury) /ARDS (Acute Respiratory Distress Syndrome) in Oncologic Pediatric Patients

Completed

• Conditions: Acute Lung Injury; Acute Respiratory Distress Syndrome; Neoplasms

• Registration Number: NCT01304654
• Lead Sponsor: Grupo de Apoio ao Adolescente e a Crianca com Cancer

Brief Summary

Identify pediatric oncologic patients with ALI/ARDS at GRAACC (Grupo de Apoio ao Adolescente e a Criança com Câncer) /IOP's (Instituto de Oncologia Pediátrica) Pediatric Intensive Care Unit and evaluate the mechanical ventilation practice in these subjects for a 48mo period.

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)

Study Timeline

• Study Start: 2011-01-08
• Study First Submitted: 2011-02-24
• Study First Submitted QC: 2011-02-24
• Study First Posted: 2011-02-25
• Status Verified: 2013-03
• Primary Completion: 2013-03-30
• Study Completion: 2013-06-15
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Identify pediatric oncologic patients with ALI/ARDS at GRAACC's PICU and evaluate how they are mechanically ventilated	2y

Secondary Outcome Measures

Name	Time	Method
Epidemiologic data about the selected patients	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.)

Trial Locations

Locations (1)

Grupo de Apoio ao Adolescente e à Criança com Câncer; 🇧🇷 Sao Paulo, Brazil