Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
200 participants
OBSERVATIONAL
2010-02-28
2011-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Pediatric ALIEN
All children from 1 month to 18 years old meeting the American-European Consensus Conference definition of acute lung injury
Evaluation oxygenation under standard ventilator settings
Measure of PaO2 under standard FiO2-PEEP
Interventions
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Evaluation oxygenation under standard ventilator settings
Measure of PaO2 under standard FiO2-PEEP
Eligibility Criteria
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Inclusion Criteria
* 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
1 Month
18 Years
ALL
No
Sponsors
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Asociación Científica Pulmón y Ventilación Mecánica
OTHER
Dr. Negrin University Hospital
OTHER
Responsible Party
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Jesus Villar
Director of Research
Principal Investigators
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Jesús Villar, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Dr. Negrin, Las Palmas de Gran Canaria, Spain
Robert M Kacmarek, RRT, PhD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts general Hospital, Boston USA
Yolanda López, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital de Cruces, Barakaldo, Vizcaya, Spain
Amelia Martínez, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Infantil del Niño Jesús, Madrid, Spain
Locations
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Jesús Villar
Las Palmas de Gran Canaria, Las Palmas, Spain
Countries
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References
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Lopez-Fernandez Y, Azagra AM, de la Oliva P, Modesto V, Sanchez JI, Parrilla J, Arroyo MJ, Reyes SB, Pons-Odena M, Lopez-Herce J, Fernandez RL, Kacmarek RM, Villar J; Pediatric Acute Lung Injury Epidemiology and Natural History (PED-ALIEN) Network. Pediatric Acute Lung Injury Epidemiology and Natural History study: Incidence and outcome of the acute respiratory distress syndrome in children. Crit Care Med. 2012 Dec;40(12):3238-45. doi: 10.1097/CCM.0b013e318260caa3.
Other Identifiers
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2010-0915-PED-ALI
Identifier Type: -
Identifier Source: org_study_id
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