NCT01131598

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 27, 2010

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

May 28, 2010

Status Verified

January 1, 2010

Enrollment Period

5 months

First QC Date

May 26, 2010

Last Update Submit

May 27, 2010

Conditions

Acute Lung InjuryAcute Respiratory Distress Syndrome

Keywords

ALISDRA

Outcome Measures

Primary Outcomes (1)

  • 1. Incidence of Pediatric ALI, ARDS and non-ALI/ARDS in Spain based on the AECC and HELP criteria.

    One year

Secondary Outcomes (1)

  • Risk factors and causes of ALI/ARDS

    One year

Eligibility Criteria

Age1 Month - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cruces Hospital

Barakaldo, Vizcaya, 48903, Spain

RECRUITING

MeSH Terms

Conditions

Acute Lung InjuryRespiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung InjuryLung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • Kacmarec and Villar Robert and Jesus, Physicians

    Spanish Intensive Care

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yolanda M Lopez, pediatrician

CONTACT

0034946006000yolandamarg.lopezfernandez@osakidetza.net

Amelia Martinez de Azagra, pediatrician

CONTACT

0034915035929amartinez.hnjs@salud.madrid.org

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 26, 2010

First Posted

May 27, 2010

Study Start

January 1, 2010

Primary Completion

June 1, 2010

Study Completion

January 1, 2011

Last Updated

May 28, 2010

Record last verified: 2010-01

Locations

ES(1)