Incidence of Acute Lung Injury in Children

NCT ID: NCT01142544

Last Updated: 2013-02-26

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

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-02-28

Study Completion Date

2011-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Acute Lung Injury Children

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pediatric ALIEN

All children from 1 month to 18 years old meeting the American-European Consensus Conference definition of acute lung injury

Evaluation oxygenation under standard ventilator settings

Intervention Type OTHER

Measure of PaO2 under standard FiO2-PEEP

Interventions

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Evaluation oxygenation under standard ventilator settings

Measure of PaO2 under standard FiO2-PEEP

Intervention Type OTHER

Eligibility Criteria

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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

* None
Minimum Eligible Age

1 Month

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asociación Científica Pulmón y Ventilación Mecánica

OTHER

Sponsor Role collaborator

Dr. Negrin University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jesus Villar

Director of Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jesús Villar, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Dr. Negrin, Las Palmas de Gran Canaria, Spain

Robert M Kacmarek, RRT, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts general Hospital, Boston USA

Yolanda López, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Cruces, Barakaldo, Vizcaya, Spain

Amelia Martínez, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Infantil del Niño Jesús, Madrid, Spain

Locations

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Jesús Villar

Las Palmas de Gran Canaria, Las Palmas, Spain

Site Status

Countries

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Spain

References

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Lopez-Fernandez Y, Azagra AM, de la Oliva P, Modesto V, Sanchez JI, Parrilla J, Arroyo MJ, Reyes SB, Pons-Odena M, Lopez-Herce J, Fernandez RL, Kacmarek RM, Villar J; Pediatric Acute Lung Injury Epidemiology and Natural History (PED-ALIEN) Network. Pediatric Acute Lung Injury Epidemiology and Natural History study: Incidence and outcome of the acute respiratory distress syndrome in children. Crit Care Med. 2012 Dec;40(12):3238-45. doi: 10.1097/CCM.0b013e318260caa3.

Reference Type DERIVED
PMID: 22990455 (View on PubMed)

Other Identifiers

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2010-0915-PED-ALI

Identifier Type: -

Identifier Source: org_study_id

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