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Short Term Outcomes of Children With Acute Respiratory Distress Syndrome

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00142376
First Posted: September 2, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Nationwide Children's Hospital
  Purpose
The study is a chart review of all children admitted over a two year period with the diagnosis of acute respiratory distress syndrome. Short term outcomes, such as mortality, length of ventilation and length of stay, will be reviewed. Factors that impact these outcomes will also be reviewed.

Condition
Acute Respiratory Distress Syndrome

Study Type: Observational
Study Design: Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Retrospective

Resource links provided by NLM:


Further study details as provided by Nationwide Children's Hospital:

Study Start Date: September 2004
Estimated Study Completion Date: August 2005
Detailed Description:

We would like to conduct a chart review of all patients with pediatric ARDS hospitalized in the PICU at Columbus Children’s Hospital in the last two years. Patients would be included for review if they met the clinical criteria for ARDS. These criteria are: rapidly progressive respiratory failure, severe hypoxemia (PaO2/FiO2 < 200), and evidence of bilateral pulmonary infiltrate on chest radiography. We estimate 40-50 patients will meet criteria.

Once criteria are met, patient charts will be pulled or reviewed electronically. We will then compose a database that includes no patient identifiers but contains information regarding the cause, length, and outcome of the ARDS admission and PICU stay. Factors such as nutritional status, antibiotic and muscle relaxant use, and type of ventilation used will be examined. Other care-related variables will be included if they are felt to impact outcome during the review process. The database will then be analyzed and information regarding pediatric ARDS outcomes in our institution will be published.

We anticipate that examining the factors that impact short term outcomes in pediatric ARDS will lead to research possibilities regarding ways to improve both short and long term outcomes in children with this illness. We propose that reviewing the disease entity as a whole will lead to improvements in caring for children with the disease, and eventually bring about a decline in mortality rates.

  Eligibility

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
Criteria

Inclusion Criteria:

  • Rapidly progressive respiratory failure,
  • Severe hypoxemia (PaO2/FiO2 < 200),
  • Evidence of bilateral pulmonary infiltrate on chest radiography
  • 0-18 years of age

Exclusion Criteria:

  • Heart failure
  • Cardiac shunt present
  Contacts and Locations
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): NCT00142376


Locations
United States, Ohio
Columbus Children's Hospital
Columbus, Ohio, United States, 43015
Sponsors and Collaborators
Nationwide Children's Hospital
Investigators
Principal Investigator: Onsy Ayad, MD Nationwide Children's Hospital
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00142376     History of Changes
Other Study ID Numbers: 0409HSE222
First Submitted: September 1, 2005
First Posted: September 2, 2005
Last Update Posted: December 9, 2005
Last Verified: September 2004

Additional relevant MeSH terms:
Syndrome
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury