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Infant Weight Gain With Trisomy 21 and CAVC

NCT00327951 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 46

Last updated 2012-03-16

No results posted yet for this study

Summary

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.

Conditions

  • Congenital Disorders

Sponsors & Collaborators

  • Children's Healthcare of Atlanta

    lead OTHER

Principal Investigators

  • Tracy M Alderson, MD · Emory University @ Children's Healthcare of Atlanta

Eligibility

Max Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-01-31
Primary Completion
2006-03-31
Completion
2008-02-29

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00327951 on ClinicalTrials.gov