Acute Lung InjuryALIENNCT01131598
Acute Lung Injury in Children: Epidemiology and Natural History. PEDIATRIC ALIEN.
An observational study of Acute Lung Injury and Acute Respiratory Distress Syndrome, run by Hospital de Cruces at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 15 years
- Conditions the study is for
- Acute Lung Injury, Acute Respiratory Distress Syndrome
- How many people
- 1 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2010to Jan 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 15 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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).
Who cannot join
- Younger than 1 month or older than 15 years old
- Cardiac disease
Trial locations and contacts
1 site in 1 country.
Yolanda M Lopez, pediatrician contact
Spain1 site, 1 recruiting
- Recruiting
Cruces Hospital
Barakaldo, Vizcaya, 48903
Yolanda M Lopez, Pediatrician, 0034946006000 ext. 6312, yolandamarg.lopezfernandez@osakidetza.net
Amelia Martinez de Azagra, Pediatrician, 0034915035929, amartinez.hnjs@salud.madrid.org
About this study
Official title: Acute Lung Injury in Spanish Children
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.
Read the detailed description
Acute lung injury (ALI) is a clinical syndrome of rapid onset of non-cardiogenic pulmonary edema manifested clinically by hypoxemia (PaO2/FiO2≤300 mmHg) and bilateral pulmonary infiltrates. When the hypoxemia is severe (PaO2/FiO2≤200 mmHg) it is termed the acute respiratory distress syndrome (ARDS). It represents a significant public health issue. Patients with ALI or ARDS require admission into critical care units for advanced life support and utilize considerable health care resources.
An immense plethora of translational knowledge has been acquired since the first description of ARDS in 1967. At the present, estimates of the incidence of ARDS and ALI in children are unknown. In adults, the estimates of ALI/ARDS incidence have varied widely, and the true magnitude of this health problem still remains unclear. Current estimates of the incidence of adult ALI/ARDS range from 15 to 80 cases per 100.000 population, or almost 40.000 cases per year in Spain. Combined mortality rates for adult ALI/ARDS range between 30-45% but it is not clear whether this figures can be translated in the pediatric population. ALI and ARDS occur as a complication or as the primary cause of critical illness in patients, usually after severe infection or trauma.
Published epidemiological studies on ALI and ARDS in the last 20 years are difficult to compare. Some reports have used different definitions for ALI and ARDS and others have evaluated the incidence during a short period of time (from days to several weeks) and then extrapolated their data to estimates of a one-year incidence. Very few studies have collected information for an entire year, and none of them have evaluated the degree of hypoxemia under standard ventilatory settings, as it has been proposed recently by the HELP Network (Am J Respir Crit Care Med 2007; 176:795-804).
- Keywords
- ALI, SDRA
- Medical subject headings
- Acute Lung Injury, Respiratory Distress Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Incidence of Pediatric ALI, ARDS and non-ALI/ARDS in Spain based on the AECC and HELP criteria.
Measured: One year
Secondary outcomes (1)
Risk factors and causes of ALI/ARDS
- Risk factors and causes of ALI/ARDS
- Mortality rates of combined ALI/ARDS, established ARDS, and non-ALI/ARDS acute respiratory failure.
- Identification of causes of death in ALI and ARDS.
- Prognostic factors associated with survival and/or fatal outcome.
- Identification of tertiles of clinical data associated with the highest or lowest mortality.
- Development of a scoring system for ALI and ARDS prognosis.
- Identification of patterns of extrapulmonary organ failure
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2010 (estimated)
- Study startJan 2010
- Primary completionJun 2010 (estimated)
- Study completionJan 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lung InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Cruces
- Sponsor type
- University, hospital or other
- Collaborators
- Spanish Intensive Care Pediatrician Society
- Investigators
- Kacmarec and Villar Robert and Jesus, Physicians, Principal investigator, Spanish Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01131598
- Sponsor's protocol ID
- Acute lung injury in children
- Acronym
- ALIEN
- Status last verified
- Jan 2010
- First submitted
- 26 May 2010
- Last updated
- 28 May 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Lung Injury in Spanish Children
- ClinicalTrials.gov ID
- NCT01131598
- Acronym / sponsor ID
- ALIEN / Acute lung injury in children
- Keywords
- ALI, SDRA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Hospital de CrucesUniversity, hospital or other
- Collaborators
- Spanish Intensive Care Pediatrician Society
- Study start
- Jan 2010
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Jan 2011 (estimated)
- First posted
- 27 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Acute lung injury (ALI) is a clinical syndrome of rapid onset of non-cardiogenic pulmonary edema manifested clinically by hypoxemia (PaO2/FiO2≤300 mmHg) and bilateral pulmonary infiltrates. When the hypoxemia is severe (PaO2/FiO2≤200 mmHg) it is termed the acute respiratory distress syndrome (ARDS). It represents a significant public health issue. Patients with ALI or ARDS require admission into critical care units for advanced life support and utilize considerable health care resources.
An immense plethora of translational knowledge has been acquired since the first description of ARDS in 1967. At the present, estimates of the incidence of ARDS and ALI in children are unknown. In adults, the estimates of ALI/ARDS incidence have varied widely, and the true magnitude of this health problem still remains unclear. Current estimates of the incidence of adult ALI/ARDS range from 15 to 80 cases per 100.000 population, or almost 40.000 cases per year in Spain. Combined mortality rates for adult ALI/ARDS range between 30-45% but it is not clear whether this figures can be translated in the pediatric population. ALI and ARDS occur as a complication or as the primary cause of critical illness in patients, usually after severe infection or trauma.
Published epidemiological studies on ALI and ARDS in the last 20 years are difficult to compare. Some reports have used different definitions for ALI and ARDS and others have evaluated the incidence during a short period of time (from days to several weeks) and then extrapolated their data to estimates of a one-year incidence. Very few studies have collected information for an entire year, and none of them have evaluated the degree of hypoxemia under standard ventilatory settings, as it has been proposed recently by the HELP Network (Am J Respir Crit Care Med 2007; 176:795-804).
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (2 listed)
- Younger than 1 month or older than 15 years old
- Cardiac disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
1. Incidence of Pediatric ALI, ARDS and non-ALI/ARDS in Spain based on the AECC and HELP criteria.
Time frame: One year
1 secondary outcome
Risk factors and causes of ALI/ARDS
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yolanda M Lopez, pediatrician contact
Kacmarec and Villar Robert and Jesus, Physicians principal investigator
Spanish Intensive Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Lung Injury and Acute Respiratory Distress Syndrome, run by Hospital de Cruces at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yolanda M Lopez, pediatrician (0034946006000 ext. 6312, yolandamarg.lopezfernandez@osakidetza.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Incidence of Pediatric ALI, ARDS and non-ALI/ARDS in Spain based on the AECC and HELP criteria. (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2010.