Incidence of Acute Lung Injury in Children (PED-ALIEN)
February 23, 2013 updated by: Jesus Villar, Dr. Negrin University Hospital
Acute Lung Injury in Children: Epidemiology and Natural History: The Pediatric ALIEN Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Las Palmas
-
Las Palmas de Gran Canaria, Las Palmas, Spain, 35010
- Jesús Villar
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 month to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Children from 1 month to 18 years old, admmitted into ICU, and meeting the American-European Consensus Conference definition for acute lung injury (ALI).
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Pediatric ALIEN
All children from 1 month to 18 years old meeting the American-European Consensus Conference definition of acute lung injury
|
Measure of PaO2 under standard FiO2-PEEP
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of cases of acute lung injury per 100,000 population
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Assessment of degree of lung severity at onset and at 24 h of the onset of acute lung injury
Time Frame: 1-year
|
1-year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jesús Villar, MD, PhD, Hospital Dr. Negrin, Las Palmas de Gran Canaria, Spain
- Principal Investigator: Robert M Kacmarek, RRT, PhD, Massachusetts general Hospital, Boston USA
- Principal Investigator: Yolanda López, MD, PhD, Hospital de Cruces, Barakaldo, Vizcaya, Spain
- Principal Investigator: Amelia Martínez, MD, PhD, Hospital Infantil del Niño Jesús, Madrid, Spain
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2010
Primary Completion (Actual)
February 1, 2011
Study Completion (Actual)
March 1, 2011
Study Registration Dates
First Submitted
June 10, 2010
First Submitted That Met QC Criteria
June 10, 2010
First Posted (Estimate)
June 11, 2010
Study Record Updates
Last Update Posted (Estimate)
February 26, 2013
Last Update Submitted That Met QC Criteria
February 23, 2013
Last Verified
February 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2010-0915-PED-ALI
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.