Racial Distribution of Heterotaxy Syndrome

Status Terminated

Clinical Trial Summary

Heterotaxy syndrome is a heterogeneous disease that is the result of a failure of normal right-left lateralization of the abdominal and thoracic organs during development. The major clinical manifestations include intestinal malrotation, functional asplenia and complex cyanotic heart disease.

Hypothesis: There exists a yet, un-recognized, racial distribution in heterotaxy syndrome.

Clinical Trial Description

The exact etiology of heterotaxy is unknown, but presumed to be multifactorial. While candidate genes have been suggested, no common gene has proven responsible for this constellation of lesions. Various modes of inheritance have been described. Though there are reports of familial occurrences, no reports of racial/ethnic predominance exist. We, therefore, propose to examine the racial/ethnic distribution of heterotaxy syndrome with congenital heart disease in patients treated at this institution. In addition, the investigators will determine if race/ethnicity is a factor in clinical outcomes.

Aim 1: To determine any pattern of racial/ethnic predominance within a cohort of patients with heterotaxy syndrome with congenital heart disease.

Aim 2: To correlate race/ethnicity with disparities in morbidity and mortality in patients with heterotaxy syndrome with congenital heart disease.

This study will be a retrospective, chart review of approximately 90 - 100 medical charts, conducted on the Egleston campus of Children's Healthcare of Atlanta. Charts reviewed will cover a period between January 1, 1990 and December 31, 2005.

Data to be collected includes: DOB, diagnosis, surgical procedure, surgical outcome, survival, length of hospitalization, repeat surgical intervention, incidence of hospitalization, length of inotropic support, ventilator time, infection rate, insurance provider, list of antibiotics and zip code of residence at initial admission. In addition to the above information, data to be extracted from the medical chart of a decedent will include age at death, cause of death, laboratory data at time of death and autopsy results. ;

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00485654
Study type	Observational
Source	Children's Healthcare of Atlanta
Contact
Status	Terminated
Phase	N/A
Start date	January 1990
Completion date	February 2008

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04405700` - Measuring Adverse Pregnancy and Newborn Congenital Outcomes
Not yet recruiting	`NCT03291678` - Impact of Percutaneous Laparoscopic Assisted Internal Ring Ligation During Lap Orchiopexy	N/A
Completed	`NCT00489788` - Predictors for Pulmonary Valve Replacement - Anatomic and Hemodynamic Using MRI	N/A
Terminated	`NCT00268060` - Infant Medical Records: Case Report Proposal	N/A
Not yet recruiting	`NCT05955794` - Vocal Pattern Assessment as a New Key to Identifying Rare Syndromes	N/A
Completed	`NCT00257517` - Multisite Feeding Study: Home Surveillance and Feeding Strategies in Infants With Complex Single Ventricle	N/A
Completed	`NCT00478296` - Pulmonary Hypertension in Trisomy 21 Patients	N/A
Completed	`NCT04556487` - Turkish Affordances in the Home Environment for Motor Development-Infant Scale (AHEMD-IS)
Terminated	`NCT00261989` - Pulse Oximetry Readings and Hourly Variation in Oximetry Readings With CHD	N/A
Completed	`NCT00211081` - Spironolactone in Patients With Single Ventricle Heart	N/A
Terminated	`NCT00268099` - Optimal Timing for Repair of Right-to-Left Shunt Lesions	N/A
Active, not recruiting	`NCT05752019` - TAAI Erasmus Research Initiative to Fight CF: Monitoring Inflammation in CF Lung Disease Into a New Era
Completed	`NCT00490295` - Biomarkers for Detection of Brain Ischemia	N/A
Terminated	`NCT00327899` - Home Inotropic Therapy in Children	N/A
Terminated	`NCT00229905` - Child With Anomalous Drainage of IVC to Left Atrium	N/A
Completed	`NCT00277901` - MRI Assessment of RV Function: Patients With TOF or Aortic Coarctation	N/A
Terminated	`NCT00366314` - Frequency of Accessing Central Lines for Blood Samples	N/A
Terminated	`NCT00268034` - Left Ventricular Aneurysms in Children	N/A
Completed	`NCT00366847` - Computer Modeling of Congenital Heart Disease	N/A
Withdrawn	`NCT00460824` - A Retrospective Review - Anti-HLA Antibodies	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.