Incidence of Acute Lung Injury in Children

Children Clinical Trial

— PED-ALIEN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01142544
• Other study ID #: 2010-0915-PED-ALI
• Status: Completed
• Phase: N/A
• First received: June 10, 2010
• Last updated: February 23, 2013
• Start date: February 2010
• Est. completion date: March 2011

Study information

• Verified date: February 2013
• Source: Dr. Negrin University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 18 Years

Eligibility

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:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Lung Injury
• Children
• Lung Injury
• Respiratory Distress Syndrome, Adult

Intervention

Other:
• Evaluation oxygenation under standard ventilator settings
Measure of PaO2 under standard FiO2-PEEP

Locations

Country	Name	City	State
Spain	Jesús Villar	Las Palmas de Gran Canaria	Las Palmas

Sponsors (2)

Lead Sponsor	Collaborator
Dr. Negrin University Hospital	Asociación Científica Pulmón y Ventilación Mecánica

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of cases of acute lung injury per 100,000 population		1 year	No
Secondary	Assessment of degree of lung severity at onset and at 24 h of the onset of acute lung injury		1-year	No