Incidence of Acute Lung Injury in Children

NCT01142544 | Completed DMC

• 1 other identifier: 2010-0915-PED-ALI
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Lung Injury; Children

Keywords

acute lung injury; incidence; lung damage; PaO2/FiO2 ratio

Outcome Measures

Primary Outcomes (1)

• Number of cases of acute lung injury per 100,000 population

  1 year

Secondary Outcomes (1)

• Assessment of degree of lung severity at onset and at 24 h of the onset of acute lung injury

  1-year

Study Arms (1)

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

Interventions

Evaluation oxygenation under standard ventilator settings OTHER

Measure of PaO2 under standard FiO2-PEEP

Pediatric ALIEN

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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).

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Dr. Negrin University Hospital: lead
• Asociación Científica Pulmón y Ventilación Mecánica: collaborator

Study Sites (1)

Jesús Villar

Las Palmas de Gran Canaria, Las Palmas, 35010, Spain

Location

Related Publications (1)

• 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.

  PMID: 22990455 DERIVED

MeSH Terms

Conditions

Acute Lung Injury

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research

Study Record Dates

• First Submitted: June 10, 2010
• First Posted: June 11, 2010
• Study Start: February 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: March 1, 2011
• Last Updated: February 26, 2013

Record last verified: 2013-02

Locations

ES (1)