Incidence of Acute Lung Injury in Children (PED-ALIEN)

This study has been completed.
Sponsor:
Collaborator:
Asociación Científica Pulmón y Ventilación Mecánica
Information provided by (Responsible Party):
Jesus Villar, Dr. Negrin University Hospital
ClinicalTrials.gov Identifier:
NCT01142544
First received: June 10, 2010
Last updated: February 23, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Acute Lung Injury
Children
Other: Evaluation oxygenation under standard ventilator settings

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Acute Lung Injury in Children: Epidemiology and Natural History: The Pediatric ALIEN Study

Resource links provided by NLM:


Further study details as provided by Dr. Negrin University Hospital:

Primary Outcome Measures:
  • Number of cases of acute lung injury per 100,000 population [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assessment of degree of lung severity at onset and at 24 h of the onset of acute lung injury [ Time Frame: 1-year ] [ Designated as safety issue: No ]

Enrollment: 200
Study Start Date: February 2010
Study Completion Date: March 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Pediatric ALIEN
All children from 1 month to 18 years old meeting the American-European Consensus Conference definition of acute lung injury
Other: Evaluation oxygenation under standard ventilator settings
Measure of PaO2 under standard FiO2-PEEP

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   1 Month to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Children from 1 month to 18 years old, admmitted into ICU, and meeting the American-European Consensus Conference definition for acute lung injury (ALI).

Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01142544

Locations
Spain
Jesús Villar
Las Palmas de Gran Canaria, Las Palmas, Spain, 35010
Sponsors and Collaborators
Dr. Negrin University Hospital
Asociación Científica Pulmón y Ventilación Mecánica
Investigators
Principal Investigator: Jesús Villar, MD, PhD Hospital Dr. Negrin, Las Palmas de Gran Canaria, Spain
Principal Investigator: Robert M Kacmarek, RRT, PhD Massachusetts general Hospital, Boston USA
Principal Investigator: Yolanda López, MD, PhD Hospital de Cruces, Barakaldo, Vizcaya, Spain
Principal Investigator: Amelia Martínez, MD, PhD Hospital Infantil del Niño Jesús, Madrid, Spain
  More Information

No publications provided by Dr. Negrin University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jesus Villar, Director of Research, Dr. Negrin University Hospital
ClinicalTrials.gov Identifier: NCT01142544     History of Changes
Other Study ID Numbers: 2010-0915-PED-ALI
Study First Received: June 10, 2010
Last Updated: February 23, 2013
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Dr. Negrin University Hospital:
acute lung injury
incidence
lung damage
PaO2/FiO2 ratio

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

ClinicalTrials.gov processed this record on July 29, 2014