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Incidence of Acute Lung Injury in Children

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01142544
Acronym
PED-ALIEN
Enrollment
200
Registered
2010-06-11
Start date
2010-02-28
Completion date
2011-03-31
Last updated
2013-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Lung Injury, Children

Keywords

acute lung injury, incidence, lung damage, PaO2/FiO2 ratio

Brief summary

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.

Detailed description

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.

Interventions

OTHEREvaluation oxygenation under standard ventilator settings

Measure of PaO2 under standard FiO2-PEEP

Sponsors

Asociación Científica Pulmón y Ventilación Mecánica
CollaboratorOTHER
Dr. Negrin University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Months to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Number of cases of acute lung injury per 100,000 population1 year

Secondary

MeasureTime frame
Assessment of degree of lung severity at onset and at 24 h of the onset of acute lung injury1-year

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026