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

27 mei 2010 bijgewerkt door: Hospital de Cruces

Acute Lung Injury in Spanish Children

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.

Studie Overzicht

Toestand

Onbekend

Conditie

Gedetailleerde beschrijving

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).

Studietype

Observationeel

Inschrijving (Verwacht)

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

Spanje
- Vizcaya
  - Baracaldo, Vizcaya, Spanje, 48903
    - Werving
    - Cruces Hospital
    - Contact:
      
      Yolanda M Lopez, Pediatrician
      
      Telefoonnummer: 6312 0034946006000
      
      E-mail: yolandamarg.lopezfernandez@osakidetza.net
    - Contact:
      
      Amelia Martinez de Azagra, Pediatrician
      
      Telefoonnummer: 0034915035929
      
      E-mail: amartinez.hnjs@salud.madrid.org
    - Onderonderzoeker:
      
      Yolanda M Lopez, Pediatrician

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

1 maand tot 15 jaar (Kind)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Tijdsspanne
1. Incidence of Pediatric ALI, ARDS and non-ALI/ARDS in Spain based on the AECC and HELP criteria. Tijdsspanne: One year	One year

Secundaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Risk factors and causes of ALI/ARDS Tijdsspanne: One year	Risk factors and causes of ALI/ARDS Mortality rates of combined ALI/ARDS, established ARDS, and non-ALI/ARDS acute respiratory failure. Identification of causes of death in ALI and ARDS. Prognostic factors associated with survival and/or fatal outcome. Identification of tertiles of clinical data associated with the highest or lowest mortality. Development of a scoring system for ALI and ARDS prognosis. Identification of patterns of extrapulmonary organ failure	One year

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Hospital de Cruces

Medewerkers

Spanish Intensive Care Pediatrician Society

Onderzoekers

Hoofdonderzoeker: Kacmarec and Villar Robert and Jesus, Physicians, Spanish Intensive Care

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 januari 2010

Primaire voltooiing (Verwacht)

1 juni 2010

Studie voltooiing (Verwacht)

1 januari 2011

Studieregistratiedata

Eerst ingediend

26 mei 2010

Eerst ingediend dat voldeed aan de QC-criteria