Acute Lung Injury in Children: Epidemiology and Natural History: The Pediatric ALIEN Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Number of cases of acute lung injury per 100,000 population
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 1 Month to 18 Years (Child, Adult)
- Sex
- All
- Accepts 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
- Not provided
Outcomes
Primary Outcomes
Number of cases of acute lung injury per 100,000 population
Time Frame: 1 year
Secondary Outcomes
- Assessment of degree of lung severity at onset and at 24 h of the onset of acute lung injury(1-year)
Investigators
Jesus Villar
Director of Research
Dr. Negrin University Hospital