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Incidence of Acute Lung Injury in Children (PED-ALIEN)

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ClinicalTrials.gov Identifier: NCT01142544
Recruitment Status : Completed
First Posted : June 11, 2010
Last Update Posted : February 26, 2013
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Acute Lung Injury Children Other: Evaluation oxygenation under standard ventilator settings

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
Actual Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Acute Lung Injury in Children: Epidemiology and Natural History: The Pediatric ALIEN Study
Study Start Date : February 2010
Primary Completion Date : February 2011
Study Completion Date : March 2011

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :
  1. Number of cases of acute lung injury per 100,000 population [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Assessment of degree of lung severity at onset and at 24 h of the onset of acute lung injury [ Time Frame: 1-year ]

Eligibility Criteria

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Ages Eligible for Study:   1 Month to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

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:

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01142544

Jesús Villar
Las Palmas de Gran Canaria, Las Palmas, Spain, 35010
Sponsors and Collaborators
Dr. Negrin University Hospital
Asociación Científica Pulmón y Ventilación Mecánica
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
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jesus Villar, Director of Research, Dr. Negrin University Hospital
ClinicalTrials.gov Identifier: NCT01142544     History of Changes
Other Study ID Numbers: 2010-0915-PED-ALI
First Posted: June 11, 2010    Key Record Dates
Last Update Posted: February 26, 2013
Last Verified: February 2013

Keywords provided by Jesus Villar, Dr. Negrin University Hospital:
acute lung injury
lung damage
PaO2/FiO2 ratio

Additional relevant MeSH terms:
Wounds and Injuries
Lung Injury
Acute Lung Injury
Respiratory Distress Syndrome, Adult
Lung Diseases
Respiratory Tract Diseases
Thoracic Injuries
Respiration Disorders