Genetic Variability and Biomarkers in Children With Acute Lung Injury

Acute Respiratory Distress Syndrome Clinical Trial

— BALI  

Official title:

Genetic Variability and Biomarkers in Children With Acute Lung Injury

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01048996
• Other study ID #: 663
• Status: Withdrawn
• Phase: N/A
• First received: January 13, 2010
• Last updated: August 21, 2015
• Start date: October 2009
• Est. completion date: June 2013

Study information

• Verified date: August 2015
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Lung Injury
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Locations

Country	Name	City	State
United States	Children's Hospital of Wisconsin	Milwaukee	Wisconsin

Sponsors (4)

Lead Sponsor	Collaborator
Medical College of Wisconsin	Children's Hospital & Research Center Oakland, National Heart, Lung, and Blood Institute (NHLBI), University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of ALI or ARDS		During PICU stay	No