Acute Respiratory Distress SyndromeBALINCT01048996
Genetic Variability and Biomarkers in Children With Acute Lung Injury
An observational study of Acute Respiratory Distress Syndrome and Acute Lung Injury, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
Acute Lung Injury (ALI) and the more severe Acute Respiratory Distress Syndrome (ARDS) are a significant problem in Pediatric Intensive Care Units, affecting up to 16 of every 1000 children admitted to these units. Read more about this study
- Who is it for?
- Ages 2 weeks to 18 years
- Conditions the study is for
- Acute Respiratory Distress Syndrome, Acute Lung Injury
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Jun 2013
- 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 2 weeks to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Subjects will be recruited concurrently with subjects recruited for the "RESTORE" sedation study. All patients who have been admited to a Pediatric Intensive/Critical Care Unit and on mechanical ventilation will be screened for eligibility at the participating institutions.
Who may be able to join
- Consecutive intubated pediatric patients (≥ 2 weeks of age and ≥ 42 weeks corrected gestational age and ≤ 18 years of age) supported on mechanical ventilation for acute pulmonary parenchymal disease enrolled in the RESTORE study.
Who cannot join
- Intubated and mechanically ventilated for immediate post-operative care and stabilization
- Cyanotic heart disease with unrepaired or palliated right to left intracardiac shunt
- History of single ventricle at any stage of repair
- Congenital diaphragmatic hernia or paralysis
- Primary pulmonary hypertension
- Critical airway (e.g., post laryngotracheal construction) or anatomical obstruction of the lower airway (e.g., mediastinal mass)
Show all 13Show fewer
- Ventilator dependent (including noninvasive) on PICU admission (chronic assisted ventilation)
- Neuromuscular respiratory failure
- Spinal cord injury above the lumbar region
- Pain managed by patient controlled analgesia (PCA) or epidural catheter
- Family/medical team has decided not to provide full support (patient treatment considered futile)
- Enrolled in any other sedation clinical trial concurrently or within the last 30 days
- Known allergy to any of the study medications
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Acute Lung Injury (ALI) and the more severe Acute Respiratory Distress Syndrome (ARDS) are a significant problem in Pediatric Intensive Care Units, affecting up to 16 of every 1000 children admitted to these units. These disorders carry with them high mortality rates as well as numerous long-term effects for the surviving children. As the effects of these diseases have significant social and economic ramifications for affected children and their families, research on the development of ALI/ARDS could significantly change how physicians understand the disease and treat patients.
There are a wide range of problems which make certain PICU patients more likely to develop either ALI or ARDS. This research aims to determine which of these children are at the greatest risk for ALI/ARDS by examining differences in plasma biomarkers and in DNA of a large number of PICU patients. We are hypothesizing that significant differences in the level of specific plasma biomarkers or in the frequency of specific DNA variants exist in children who develop ALI/ARDS.
- Keywords
- Acute Lung Injury, Acute Respiratory Distress Syndrome, Genetic Variability, Plasma Biomarkers, Pediatrics
- Medical subject headings
- Respiratory Distress Syndrome, Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Non ALI/ARDS | Those patient who enrolled in the study but did not develop ALI or ARDS during their hospital course. | |
| ALI/ARDS | Those patients who enrolled in the study and developed ALI or ARDS during their hospital course. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of ALI or ARDS
Measured: During PICU stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2010 (estimated)
- Study startOct 2009
- Primary completionJun 2013 (estimated)
- Study completionJun 2013 (estimated)
Why it stopped: PI has left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), UCSF Benioff Children's Hospital Oakland, University of California, San Francisco
- Responsible party
- Sponsor
- Investigators
- Michael Quasney, PhD, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01048996
- Sponsor's protocol ID
- 663
- Acronym
- BALI
- Status last verified
- Aug 2015
- First submitted
- 13 Jan 2010
- Last updated
- 24 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Variability and Biomarkers in Children With Acute Lung Injury
- ClinicalTrials.gov ID
- NCT01048996
- Acronym / sponsor ID
- BALI / 663
- Keywords
- Acute Lung Injury, Acute Respiratory Distress Syndrome, Genetic Variability, Plasma Biomarkers, Pediatrics
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: PI has left institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), UCSF Benioff Children's Hospital Oakland, University of California, San Francisco
- Study start
- Oct 2009
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 14 Jan 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 (ALI) and the more severe Acute Respiratory Distress Syndrome (ARDS) are a significant problem in Pediatric Intensive Care Units, affecting up to 16 of every 1000 children admitted to these units. These disorders carry with them high mortality rates as well as numerous long-term effects for the surviving children. As the effects of these diseases have significant social and economic ramifications for affected children and their families, research on the development of ALI/ARDS could significantly change how physicians understand the disease and treat patients.
There are a wide range of problems which make certain PICU patients more likely to develop either ALI or ARDS. This research aims to determine which of these children are at the greatest risk for ALI/ARDS by examining differences in plasma biomarkers and in DNA of a large number of PICU patients. We are hypothesizing that significant differences in the level of specific plasma biomarkers or in the frequency of specific DNA variants exist in children who develop ALI/ARDS.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non ALI/ARDS | – | –Those patient who enrolled in the study but did not develop ALI or ARDS during their hospital course. |
| ALI/ARDS | – | –Those patients who enrolled in the study and developed ALI or ARDS during their hospital course. |
Who may qualify
- Ages
- 2 weeks to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Subjects will be recruited concurrently with subjects recruited for the "RESTORE" sedation study. All patients who have been admited to a Pediatric Intensive/Critical Care Unit and on mechanical ventilation will be screened for eligibility at the participating institutions.
Key inclusion criteria (1 listed)
- Consecutive intubated pediatric patients (≥ 2 weeks of age and ≥ 42 weeks corrected gestational age and ≤ 18 years of age) supported on mechanical ventilation for acute pulmonary parenchymal disease enrolled in the RESTORE study.
Key exclusion criteria (13 listed)
- Intubated and mechanically ventilated for immediate post-operative care and stabilization
- Cyanotic heart disease with unrepaired or palliated right to left intracardiac shunt
- History of single ventricle at any stage of repair
- Congenital diaphragmatic hernia or paralysis
- Primary pulmonary hypertension
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
Development of ALI or ARDS
Time frame: During PICU stay
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2015.
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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.
Michael Quasney, PhD, MD principal investigator
Medical College of Wisconsin
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 Respiratory Distress Syndrome and Acute Lung Injury, run by Medical College of Wisconsin at 1 site in United States.
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 1 inclusion and 13 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: withdrawn, as of the sponsor's last update on 24 Aug 2015. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Development of ALI or ARDS (time frame: During PICU stay). 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 24 Aug 2015.