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OpenTrials
Completed

NCT Number: NCT01304654

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

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.

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Key information

Age range

29 day–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Grupo de Apoio ao Adolescente e à Criança com Câncer

São Paulo, 04023-062, Brazil

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Identify pediatric oncologic patients with ALI/ARDS at GRAACC's PICU and evaluate how they are mechanically ventilated

    Time frame: 2y

Secondary outcomes

  1. Epidemiologic data about the selected patients

    Time frame: 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.)

Sponsors and collaborators

Lead sponsor

Grupo de Apoio ao Adolescente e a Crianca com Cancer

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Feb 25, 2011
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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