Clinical trial NCT01142544: Incidence of Acute Lung Injury in Children
Official title: Acute Lung Injury in Children: Epidemiology and Natural History: The Pediatric ALIEN Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Lung Injury
Children
Keywords: acute lung injury
incidence
lung damage
PaO2/FiO2 ratio
Lead sponsor: Dr. Negrin University Hospital
Sponsor class: OTHER
Collaborators: name: Asociación Científica Pulmón y Ventilación Mecánica
First posted: 2010-06-11
Enrollment: 200
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

Brief summary: 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: 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 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

Primary outcomes:
measure: Number of cases of acute lung injury per 100,000 population
timeFrame: 1 year
Secondary outcomes:
measure: Assessment of degree of lung severity at onset and at 24 h of the onset of acute lung injury
timeFrame: 1-year
Other outcomes:
Locations:
city: Las Palmas de Gran Canaria
country: Spain
facility: Jesús Villar
state: Las Palmas
Study officials:
affiliation: Hospital Dr. Negrin, Las Palmas de Gran Canaria, Spain
name: Jesús Villar, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts general Hospital, Boston USA
name: Robert M Kacmarek, RRT, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de Cruces, Barakaldo, Vizcaya, Spain
name: Yolanda López, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Infantil del Niño Jesús, Madrid, Spain
name: Amelia Martínez, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.