ALI (Acute Lung Injury) /ARDS (Acute Respiratory Distress Syndrome) 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 (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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 29

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil, 04023-062
    • Grupo de Apoio ao Adolescente e à Criança com Câncer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 weeks to 17 years (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Pediatric oncologic patients

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Grupo de Apoio ao Adolescente e a Crianca com Cancer
• Investigators: Principal Investigator: Rodrigo G Arduini, MD, Grupo de Apoio ao Adolescente e à Criança com Câncer

Study record dates

Study Major Dates

• Study Start: January 8, 2011
• Primary Completion (Actual): March 30, 2013
• Study Completion (Actual): June 15, 2013

Study Registration Dates

• First Submitted: February 24, 2011
• First Submitted That Met QC Criteria: February 24, 2011
• First Posted (Estimated): February 25, 2011

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 10, 2025
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: child; acute lung injury; neoplasms; respiratory distress syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease; Lung Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Thoracic Injuries; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Wounds and Injuries; Lung Injury; Acute Lung Injury
• Other Study ID Numbers: UTI/IOP 02/11; 0031/11 (Other Identifier: CEP UNIFESP)