Infant Weight Gain With Trisomy 21 and CAVC

This study has been terminated.
(sufficient data collected for significant conclusion)
Sponsor:
Information provided by:
Children's Healthcare of Atlanta
ClinicalTrials.gov Identifier:
NCT00327951
First received: May 18, 2006
Last updated: March 14, 2012
Last verified: February 2008
  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

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: The Impact of Weight Gain in the Pre-operative Infant With Trisomy 21 (Down Syndrome) and Complete Atrioventricular Canal (CAVC)

Resource links provided by NLM:


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

Enrollment: 46
Study Start Date: January 2001
Study Completion Date: February 2008
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
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
Sampling Method:   Non-Probability Sample
Study Population

patients' charts from Children's Healthcare of Atlanta

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
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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

Responsible Party: Children's Healthcare of Atlanta Institutional Review Board, IRB Chairman
ClinicalTrials.gov Identifier: NCT00327951     History of Changes
Other Study ID Numbers: 06-109
Study First Received: May 18, 2006
Last Updated: March 14, 2012
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

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

ClinicalTrials.gov processed this record on July 22, 2014