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NCT00327951 · ClinicalTrials.gov registry record
Infant Weight Gain With Trisomy 21 and CAVC
A clinical trial, sponsored by Children's Healthcare of Atlanta.
- Terminated
- Registry status
- 46
- Enrollment target
NCT00327951: Clinical Trial study, sponsored by Children's Healthcare of Atlanta.
NCT00327951 is a clinical trial that was terminated before completion, run by Children's Healthcare of Atlanta. The registered enrollment target is 46 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00327951 was terminated before completion, sponsored by Children's Healthcare of Atlanta.
- TERMINATED
- Registry status
- 46 participants
- Enrollment target
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.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2001-01 |
| Est. Completion | 2008-02 |
Why NCT00327951 stopped before completion
NCT00327951 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 46 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT00327951 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00327951 about?
NCT00327951 is a clinical study titled "Infant Weight Gain With Trisomy 21 and CAVC". 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 o...
What is the current status of trial NCT00327951?
This trial is currently terminated. The enrollment target is 46 participants. The study started on 2001-01. Estimated completion is 2008-02.
Who is sponsoring clinical trial NCT00327951?
This trial is sponsored by Children's Healthcare of Atlanta, which has 80 total clinical trials registered on ClinicalTrials.gov.
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