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Infant Weight Gain With Trisomy 21 and CAVC
This study is ongoing, but not recruiting participants.
First Received: May 18, 2006   No Changes Posted
Sponsored by: Children's Healthcare of Atlanta
Information provided by: Children's Healthcare of Atlanta
ClinicalTrials.gov Identifier: NCT00327951
  Purpose

Failure to thrive and difficulty gaining weight is a sign of uncompensated congestive heart failure (CHF). Infants with Trisomy 21 and complete atrioventricular canal defects (CAVC) frequently develop uncompensated CHF and weight gain failure pre-operatively. A weight of 5 kg has been suggested as optimal for timing of CAVC repair. A delay in surgical repair often occurs if weight gain stalls and reaches a plateau prior to reaching 5 kg. A retrospective review performed by Kogon, et al, of children undergoing surgery for VSD at CHOA at Egleston recently reported that age and weight at surgery may not, however, be associated with adverse surgical outcome.

The purpose of this study is to determine the optimal timing for surgical correction of CAVC in Trisomy 21 infants based on reaching a plateau of failed weight gain despite maximal anti-congestive and nutritional therapy.


Condition
Congenital Disorders

Genetics Home Reference related topics: Down syndrome
MedlinePlus related topics: Down Syndrome Surgery
U.S. FDA Resources
Study Type: Observational
Study Design: Natural History, Longitudinal, Defined Population, Retrospective Study
Official Title: The Impact of Weight Gain in the Pre-Operative Infant With Trisomy 21 (Down Syndrome) and Complete Atrioventricular Canal (CAVC)

Further study details as provided by Children's Healthcare of Atlanta:

Estimated Enrollment: 100
Study Start Date: January 2001
Detailed Description:

A retrospective chart review of 100 infants with Trisomy 21 and CAVC operated at CHOA at Egleston between January 1, 2001 and March 24, 2006 will be performed. Graphs of birth weight and rate of weight gain over time will be plotted for each patient and for the group as a whole. The point of reaching a plateau of weight gain will be decided for each patient and indexed for birth weight. Medical management will be detailed, i.e. all medications and all dietary information (caloric density of formula, route of administration). This medical management will be indexed as a function on the weight gain chart. Medical complications (such as respiratory infections, gastroenteritis, hospitalizations, and additional non-cardiac medications) will likewise be plotted and segmented according to position relative to the weight gain plateau. Age at eventual surgery and whether surgical date was delayed by complications will be noted. Surgical cardiopulmonary bypass time and morbidity and mortality will be noted. Postoperative length of ventilator support, length of stay in the CICU and total length of stay will be determined and also displayed as a function of body weight and as a function of time at plateau weight. Postoperative morbidity and mortality for the three months after repair will be noted, including all cause hospital re-admissions and outpatient medical complications (such as respiratory infections, gastroenteritis, and the need for continued medications for CHF).

  Eligibility

Ages Eligible for Study:   up to 1 Year
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Infants with Trisomy 21 and CAVC operated on at CHOA at Egleston between January 1, 2001 and December 31, 2005 will be included in the study.

Exclusion Criteria:

  • Patients will be excluded if the following information is not available:

A. Birth weight B. Weight at operation C. Incomplete medical records e.g. patient followed preoperatively elsewhere

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00327951

Locations
United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Children's Healthcare of Atlanta
Investigators
Principal Investigator: Tracy M Alderson, MD Emory University @ Children's Healthcare of Atlanta
  More Information

No publications provided

Study ID Numbers: 06-109
Study First Received: May 18, 2006
Last Updated: May 18, 2006
ClinicalTrials.gov Identifier: NCT00327951     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Children's Healthcare of Atlanta:
pediatric
cardiac
weight gain pre-operative
trisomy 21
complete atrioventricular canal

Study placed in the following topic categories:
Aneuploidy
Chromosome Disorders
Trisomy
Weight Gain
Body Weight
Mental Retardation
Signs and Symptoms
Complete Atrioventricular Canal
Genetic Diseases, Inborn
Body Weight Changes
Abnormalities, Multiple
Chromosome Aberrations
Neurologic Manifestations
Down Syndrome
Congenital Abnormalities
Neurobehavioral Manifestations

Additional relevant MeSH terms:
Aneuploidy
Nervous System Diseases
Chromosome Disorders
Trisomy
Weight Gain
Body Weight
Mental Retardation
Signs and Symptoms
Pathologic Processes
Genetic Diseases, Inborn
Body Weight Changes
Abnormalities, Multiple
Chromosome Aberrations
Neurologic Manifestations
Down Syndrome
Congenital Abnormalities
Neurobehavioral Manifestations

ClinicalTrials.gov processed this record on May 07, 2009