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

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2011-01-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Acute Lung Injury Acute Respiratory Distress Syndrome

Keywords

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ALI SDRA

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

1 Month

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Spanish Intensive Care Pediatrician Society

Principal Investigators

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Kacmarec and Villar Robert and Jesus, Physicians

Role: PRINCIPAL_INVESTIGATOR

Spanish Intensive Care

Locations

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Cruces Hospital

Barakaldo, Vizcaya, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Yolanda M Lopez, pediatrician

Role: CONTACT

Phone: 0034946006000

Email: [email protected]

Amelia Martinez de Azagra, pediatrician

Role: CONTACT

Phone: 0034915035929

Email: [email protected]

Facility Contacts

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Yolanda M Lopez, Pediatrician

Role: primary

Amelia Martinez de Azagra, Pediatrician

Role: backup

Other Identifiers

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