Acute Lung Injury in Children: Epidemiology and Natural History. PEDIATRIC ALIEN. (ALIEN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01131598
Recruitment Status : Unknown
Verified January 2010 by Hospital de Cruces.
Recruitment status was:  Recruiting
First Posted : May 27, 2010
Last Update Posted : May 28, 2010
Spanish Intensive Care Pediatrician Society
Information provided by:
Hospital de Cruces

Brief Summary:
The investigators propose to perform a one-year prospective audit of all Acute lung injury (ALI)and cute respiratory distress syndrome (ARDS) pediatric patients managed in several ICUs in Spain. The investigators intend to collect data from all children (from 1 month to 18 years of age) admitted with or developing ALI/ARDS with the aim to understand the epidemiology and natural history of acute lung injury in the pediatric setting. These ICUs are scattered through the Spain and are representative of the demographic differences across the country.

Condition or disease
Acute Lung Injury Acute Respiratory Distress Syndrome

Detailed Description:

Acute lung injury (ALI) is a clinical syndrome of rapid onset of non-cardiogenic pulmonary edema manifested clinically by hypoxemia (PaO2/FiO2≤300 mmHg) and bilateral pulmonary infiltrates. When the hypoxemia is severe (PaO2/FiO2≤200 mmHg) it is termed the acute respiratory distress syndrome (ARDS). It represents a significant public health issue. Patients with ALI or ARDS require admission into critical care units for advanced life support and utilize considerable health care resources.

An immense plethora of translational knowledge has been acquired since the first description of ARDS in 1967. At the present, estimates of the incidence of ARDS and ALI in children are unknown. In adults, the estimates of ALI/ARDS incidence have varied widely, and the true magnitude of this health problem still remains unclear. Current estimates of the incidence of adult ALI/ARDS range from 15 to 80 cases per 100.000 population, or almost 40.000 cases per year in Spain. Combined mortality rates for adult ALI/ARDS range between 30-45% but it is not clear whether this figures can be translated in the pediatric population. ALI and ARDS occur as a complication or as the primary cause of critical illness in patients, usually after severe infection or trauma.

Published epidemiological studies on ALI and ARDS in the last 20 years are difficult to compare. Some reports have used different definitions for ALI and ARDS and others have evaluated the incidence during a short period of time (from days to several weeks) and then extrapolated their data to estimates of a one-year incidence. Very few studies have collected information for an entire year, and none of them have evaluated the degree of hypoxemia under standard ventilatory settings, as it has been proposed recently by the HELP Network (Am J Respir Crit Care Med 2007; 176:795-804).

Study Type : Observational
Estimated Enrollment : 1 participants
Time Perspective: Prospective
Official Title: Acute Lung Injury in Spanish Children
Study Start Date : January 2010
Estimated Primary Completion Date : June 2010
Estimated Study Completion Date : January 2011

Primary Outcome Measures :
  1. 1. Incidence of Pediatric ALI, ARDS and non-ALI/ARDS in Spain based on the AECC and HELP criteria. [ Time Frame: One year ]

Secondary Outcome Measures :
  1. Risk factors and causes of ALI/ARDS [ Time Frame: One year ]
    1. Risk factors and causes of ALI/ARDS
    2. Mortality rates of combined ALI/ARDS, established ARDS, and non-ALI/ARDS acute respiratory failure.
    3. Identification of causes of death in ALI and ARDS.
    4. Prognostic factors associated with survival and/or fatal outcome.
    5. Identification of tertiles of clinical data associated with the highest or lowest mortality.
    6. Development of a scoring system for ALI and ARDS prognosis.
    7. Identification of patterns of extrapulmonary organ failure

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   1 Month to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients, age ranging from 1 month to 18 years old, meeting the American European Consensus (AECC) definition of ALI and ARDS will be included regardless of etiology of respiratory failure.

Inclusion criteria:

  • All patients, age ranging from 1 month to 15 years old
  • Must be able to meet the American European Consensus definition of ALI and ARDS(no indication of heart failure or a pulmonary capillary wedge pressure of greater than 18 mmHg, with pulmonary infiltrates in all four quadrants and a PaO2/FIO2 of > 200 to <300 mmHg (ALI) or ? 200 mmHg (ARDS).

Exclusion criteria:

  • Younger than 1 month or older than 15 years old
  • Cardiac disease

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 identifier (NCT number): NCT01131598

Contact: Yolanda M Lopez, pediatrician 0034946006000 ext 6312
Contact: Amelia Martinez de Azagra, pediatrician 0034915035929

Cruces Hospital Recruiting
Baracaldo, Vizcaya, Spain, 48903
Contact: Yolanda M Lopez, Pediatrician    0034946006000 ext 6312   
Contact: Amelia Martinez de Azagra, Pediatrician    0034915035929   
Sub-Investigator: Yolanda M Lopez, Pediatrician         
Sponsors and Collaborators
Hospital de Cruces
Spanish Intensive Care Pediatrician Society
Principal Investigator: Kacmarec and Villar Robert and Jesus, Physicians Spanish Intensive Care

Responsible Party: Jesús Villar and Robert Kacmarek, Spanish Intensive Care Pediatrician Society Identifier: NCT01131598     History of Changes
Other Study ID Numbers: Acute lung injury in children
First Posted: May 27, 2010    Key Record Dates
Last Update Posted: May 28, 2010
Last Verified: January 2010

Keywords provided by Hospital de Cruces:

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