Short Term Outcomes of Children With Acute Respiratory Distress Syndrome

This study has been completed.
Sponsor:
Information provided by:
Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT00142376
First received: September 1, 2005
Last updated: NA
Last verified: September 2004
History: No changes posted
  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
Time Perspective: Longitudinal

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

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: September 1, 2005
Last Updated: September 1, 2005
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 23, 2014