Acute Lung InjuryPED-ALIENNCT01142544
Incidence of Acute Lung Injury in Children
An observational study of Acute Lung Injury and Children, run by Hospital Universitario de Gran Canaria Doctor Negrín at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Acute Lung Injury, Children
- What is being tested?
- Evaluation oxygenation under standard ventilator settings
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2010to Mar 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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).
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Lung Injury in Children: Epidemiology and Natural History: The Pediatric ALIEN Study
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.
Read the 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.
- Conditions
- Acute Lung Injury, Children
- Being tested
- Evaluation oxygenation under standard ventilator settings
- Keywords
- acute lung injury, incidence, lung damage, PaO2/FiO2 ratio
- Medical subject headings
- Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation oxygenation under standard ventilator settingsOther
Measure of PaO2 under standard FiO2-PEEP
| Study group | Role | What they receive |
|---|---|---|
| Pediatric ALIEN | All children from 1 month to 18 years old meeting the American-European Consensus Conference definition of acute lung injury Receives: Other: Evaluation oxygenation under standard ventilator settings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of cases of acute lung injury per 100,000 population
Measured: 1 year
Secondary outcomes (1)
Assessment of degree of lung severity at onset and at 24 h of the onset of acute lung injury
Measured: 1-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2010 (estimated)
- Study startFeb 2010
- Primary completionFeb 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario de Gran Canaria Doctor Negrín
- Sponsor type
- University, hospital or other
- Collaborators
- Asociación Científica Pulmón y Ventilación Mecánica
- Responsible party
- Principal investigator, Jesus Villar, Hospital Universitario de Gran Canaria Doctor Negrín
- Investigators
- Jesús Villar, MD, PhD, Principal investigator, Hospital Dr. Negrin, Las Palmas de Gran Canaria, SpainRobert M Kacmarek, RRT, PhD, Principal investigator, Massachusetts general Hospital, Boston USAYolanda López, MD, PhD, Principal investigator, Hospital de Cruces, Barakaldo, Vizcaya, SpainAmelia Martínez, MD, PhD, Principal investigator, Hospital Infantil del Niño Jesús, Madrid, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01142544
- Sponsor's protocol ID
- 2010-0915-PED-ALI
- Acronym
- PED-ALIEN
- Status last verified
- Feb 2013
- First submitted
- 10 Jun 2010
- Last updated
- 26 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22990455
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Lung Injury in Children: Epidemiology and Natural History: The Pediatric ALIEN Study
- ClinicalTrials.gov ID
- NCT01142544
- Acronym / sponsor ID
- PED-ALIEN / 2010-0915-PED-ALI
- Conditions
- Acute Lung Injury, Children
- Keywords
- acute lung injury, incidence, lung damage, PaO2/FiO2 ratio
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Hospital Universitario de Gran Canaria Doctor NegrínUniversity, hospital or other
- Collaborators
- Asociación Científica Pulmón y Ventilación Mecánica
- Study start
- Feb 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 11 Jun 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric ALIEN | – | Other: Evaluation oxygenation under standard ventilator settingsAll children from 1 month to 18 years old meeting the American-European Consensus Conference definition of acute lung injury |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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).
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation oxygenation under standard ventilator settingsMeasure of PaO2 under standard FiO2-PEEP | Other | Pediatric ALIEN |
Primary outcome
Number of cases of acute lung injury per 100,000 population
Time frame: 1 year
1 secondary outcome
Assessment of degree of lung severity at onset and at 24 h of the onset of acute lung injury
Time frame: 1-year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2013.
- Derived from this study: PubMed 22990455Lopez-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.
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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.
Jesús Villar, MD, PhD principal investigator
Hospital Dr. Negrin, Las Palmas de Gran Canaria, Spain
Robert M Kacmarek, RRT, PhD principal investigator
Massachusetts general Hospital, Boston USA
Yolanda López, MD, PhD principal investigator
Hospital de Cruces, Barakaldo, Vizcaya, Spain
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 Children, run by Hospital Universitario de Gran Canaria Doctor Negrín 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 4 inclusion and 1 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: finished, as of the sponsor's last update on 26 Feb 2013. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of cases of acute lung injury per 100,000 population (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01142544, which also lists 1 linked publication.
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 26 Feb 2013.