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

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Children's Hospital & Research Center Oakland
University of California, San Francisco
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT01048996
First received: January 13, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted
  Purpose

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
Acute Respiratory Distress Syndrome
Acute Lung Injury

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Genetic Variability and Biomarkers in Children With Acute Lung Injury

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • Development of ALI or ARDS [ Time Frame: During PICU stay ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

3 samples will be collected from each patient, one whole blood and three plasma samples will be retained.


Estimated Enrollment: 2450
Study Start Date: October 2009
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01048996

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

No publications provided

Responsible Party: Michael Quasney, MD, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT01048996     History of Changes
Other Study ID Numbers: 663, 1R01HL095410-01A1
Study First Received: January 13, 2010
Last Updated: January 13, 2010
Health Authority: United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
Acute Lung Injury
Acute Respiratory Distress Syndrome
Genetic Variability
Plasma Biomarkers
Pediatrics

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

ClinicalTrials.gov processed this record on May 19, 2013