Genetic Variability and Biomarkers in Children With Acute Lung Injury

Study Overview
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Brief Summary
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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.

Official Title
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Genetic Variability and Biomarkers in Children With Acute Lung Injury

Conditions
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Acute Respiratory Distress Syndrome, Acute Lung Injury

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Weeks
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non ALI/ARDS<br>Those patient who enrolled in the study but did not develop ALI or ARDS during their hospital course. | |
| ALI/ARDS<br>Those patients who enrolled in the study and developed ALI or ARDS during their hospital course. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of ALI or ARDS |  | During PICU stay | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Lung Injury, Acute Respiratory Distress Syndrome, Genetic Variability, Plasma Biomarkers, Pediatrics