Sponsor study identifier
observational
46
1 country
1
Study Start
January 2001
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2006
Actual (reported)Study Completion
February 2008
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2008
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2001
Date type not reportedThis date has not been verified as actual or estimated.
March 2006
Actual (reported)May 18, 2006
Actual (reported)May 19, 2006
Actual (reported)February 2008
Actual (reported)patients' charts from Children's Healthcare of Atlanta
Contact the study team to confirm eligibility.
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322, United States
Tracy M Alderson, MD
Emory University @ Children's Healthcare of Atlanta
46 participants (actual enrollment reported by the registry).
First Submitted
May 18, 2006
First Posted
May 19, 2006
Study Start
January 2001
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2006
Actual (reported)Study Completion
February 2008
Actual (reported)Last Updated
March 16, 2012
Record last verified: 2008-02
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Source: ClinicalTrials.gov.
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