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Completed

NCT Number: NCT01142544

Incidence of Acute Lung Injury in Children

Acute lung injury in children is a syndrome of rapid onset of acute respiratory failure and require admission into intensive care units (ICU) for advanced life support. There are almost no information on epidemiology of acute lung injury. Published studies do not have information for an entire year and none of them have evaluated the degree of oxygenation failure under standard ventilator settings. The investigators will perform a 1-year prospective audit of all patients admitted with acute lung injury in a network of pediatric ICUs in Spain.

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Key information

Conditions

Acute Lung Injury Children Lung Diseases Lung Injury Respiratory Tract Diseases

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Jesús Villar

Las Palmas de Gran Canaria, Las Palmas, 35010, Spain

About this study

We will evaluate oxygenation under standard ventilator settings (FiO2 0.5 and 1 on PEEP 5 or 10 cmH2O) in pediatric acute respiratory distress syndrome.

Outcome measures will include: overall ICU mortality, number of patients meeting ARDS criteria at 24 hours, and stratification of patients depending on PaO2/FiO2 ratio at 24 h of meeting acute respiratory distress syndrome criteria.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Acute onset of respiratory failure
  • Age 1 month to 18 years old
  • Bilateral pulmonary infiltrates on Chest X-ray
  • Absence of left ventricular failure, PaO2/FiO2>300 mmHg

Exclusion criteria

  • None

Treatment and study plan

Evaluation oxygenation under standard ventilator settings

Other

Measure of PaO2 under standard FiO2-PEEP

Primary outcomes

  1. Number of cases of acute lung injury per 100,000 population

    Time frame: 1 year

Secondary outcomes

  1. Assessment of degree of lung severity at onset and at 24 h of the onset of acute lung injury

    Time frame: 1-year

Sponsors and collaborators

Lead sponsor

Hospital Universitario de Gran Canaria Doctor Negrín

Other

Collaborators

  • Asociación Científica Pulmón y Ventilación Mecánica

Registry information

Official study title

Acute Lung Injury in Children: Epidemiology and Natural History: The Pediatric ALIEN Study

Acronym: PED-ALIEN

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 11, 2010
Registry last updated
Feb 26, 2013

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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