Infant Weight Gain With Trisomy 21 and CAVC

NCT00327951 | Terminated

• 1 other identifier: 06-109
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

pediatric; cardiac; weight gain pre-operative; trisomy 21; complete atrioventricular canal

Eligibility Criteria

• Age: Up to 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

patients' charts from Children's Healthcare of Atlanta

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Healthcare of Atlanta: lead

Study Sites (1)

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Down Syndrome; Complete atrioventricular septal defect

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Study Officials

• Tracy M Alderson, MD

  Emory University @ Children's Healthcare of Atlanta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 18, 2006
• First Posted: May 19, 2006
• Study Start: January 1, 2001
• Primary Completion: March 1, 2006
• Study Completion: February 1, 2008
• Last Updated: March 16, 2012

Record last verified: 2008-02

Locations

US (1)