- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00327977
Hypoxemia in Infants After Palliative Surgery
A Retrospective Study of Hypoxemia in Infants After Palliative Neonatal Surgery for Congenital Heart Disease
Study Overview
Status
Conditions
Detailed Description
We wish to do a retrospective review of clinical data on infants who have undergone surgical palliation for the following cardiac defects over the past five years (from January 1, 2001 through March 31, 2006):
Hypoplastic left heart syndrome Pulmonary atresia Severe pulmonary stenosis.
The patient charts, between the dates of 01.01.2001and 03.31.2006, will be reviewed from Children's Healthcare of Atlanta, Egleston Hospital and the Sibley Heart Center Cardiology clinics of Children's Healthcare of Atlanta.
We will review approximately 180 charts.
We will collect the following information on each patient:
Medical Record Number Account number Dates of admission, discharge, treatment or death, date of birth Information regarding cardiac signs and symptoms, medication information Age, weight , diagnoses and results of imaging studies Clinic visit information during routine follow up appointments such as weight, length, head circumference, oxygen saturations, vital signs, medications, diet, blood pressures, symptoms,blood tests, chest x-ray findings, dates and types of procedures Readmissions, feeding regimen, cardiac catheterization data, surgical data Parent histories of developmental milestones, physical therapy and speech therapy consultations, feeding history, evaluations of swallowing function Airway symptoms Noncardiac procedures and noncardiac medical problems Family history and social history as it relates to care of the infants at home, complications of medical or surgical treatment and cerebral oximetry.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Georgia
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Atlanta, Georgia, United States, 30322
- Children's Healthcare of Atlanta
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- patient charts from 01/01/2001 through 03/31/2006 seen at Children's Healthcare of Atlanta or Sibley Heart Center Cardiology for surgical palliation for Hypoplastic left heart syndrome or surgical palliation for Pulmonary atresia or surgical palliation for Severe pulmonary stenosis
Exclusion Criteria:
- Those who do not meet inclusion criteria
Study Plan
How is the study designed?
Design Details
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Analyze the growth and development of infants with post-surgical palliation in infancy and assess variations in oxygenation saturations and hemodynamics as they relate to weight gain, linear growth and increases in head circumference.
Time Frame: 5 years
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Ongoing data analysis of risk factors for death in the high risk population has revealed that some aspects of the clinical course of these patients which are new to the field.
Episodes of decomposition may not have been sudden as previously thought, but may have been preceded by some mild signs of change in cardiovascular status.
This may in fact have led to changes in clinical course that were undetected because this was a new clinical finding.
|
5 years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Martha L Clabby, MD, Children's Healthcare of Atlanta, Sibley Heart Center Cardiology
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 06-128
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