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Terminated No phase listed Observational

Infant Weight Gain With Trisomy 21 and CAVC

ClinicalTrials.gov ID: NCT00327951

Public ClinicalTrials.gov record NCT00327951. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 8, 2026, 5:58 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

The Impact of Weight Gain in the Pre-operative Infant With Trisomy 21 (Down Syndrome) and Complete Atrioventricular Canal (CAVC)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00327951
Recruitment status
Terminated
Study type
Observational
Phase
Not listed
Enrollment
46 participants

Conditions and interventions

Interventions

Not listed

Eligibility (public fields only)

Age range
Up to 1 Year
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 31, 2000
Primary completion
Feb 28, 2006
Completion
Jan 31, 2008
Last update posted
Mar 15, 2012

2001 – 2008

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Children's Healthcare of Atlanta Atlanta Georgia 30322

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00327951, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 15, 2012 · Synced Sep 8, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00327951 live on ClinicalTrials.gov.

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