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Genetic Variability and Biomarkers in Children With Acute Lung Injury (BALI)

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ClinicalTrials.gov Identifier: NCT01048996
Recruitment Status : Withdrawn (PI has left institution)
First Posted : January 14, 2010
Last Update Posted : August 24, 2015
National Heart, Lung, and Blood Institute (NHLBI)
Children's Hospital & Research Center Oakland
University of California, San Francisco
Information provided by (Responsible Party):
Medical College of Wisconsin

Brief 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. 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.

Condition or disease
Acute Respiratory Distress Syndrome Acute Lung Injury

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Genetic Variability and Biomarkers in Children With Acute Lung Injury
Study Start Date : October 2009
Estimated Primary Completion Date : June 2013
Estimated Study Completion Date : June 2013

Those patient who enrolled in the study but did not develop ALI or ARDS during their hospital course.
Those patients who enrolled in the study and developed ALI or ARDS during their hospital course.

Primary Outcome Measures :
  1. Development of ALI or ARDS [ Time Frame: During PICU stay ]

Biospecimen Retention:   Samples With DNA
3 samples will be collected from each patient, one whole blood and three plasma samples will be retained.

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01048996

United States, Wisconsin
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Medical College of Wisconsin
National Heart, Lung, and Blood Institute (NHLBI)
Children's Hospital & Research Center Oakland
University of California, San Francisco
Principal Investigator: Michael Quasney, PhD, MD Medical College of Wisconsin

Responsible Party: Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT01048996     History of Changes
Other Study ID Numbers: 663
First Posted: January 14, 2010    Key Record Dates
Last Update Posted: August 24, 2015
Last Verified: August 2015

Keywords provided by Medical College of Wisconsin:
Acute Lung Injury
Acute Respiratory Distress Syndrome
Genetic Variability
Plasma Biomarkers

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Wounds and Injuries
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Thoracic Injuries