NCT00006272

Brief Summary

OBJECTIVES: I. Compare the total daily energy expenditure in infants with ventricular septal defects vs healthy control infants.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1994

Completed
6.1 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 12, 2000

Completed
Last Updated

June 24, 2005

Status Verified

December 1, 2003

First QC Date

September 11, 2000

Last Update Submit

June 23, 2005

Conditions

Heart Septal Defects, Ventricular

Keywords

cardiovascular and respiratory diseasesheart defectsrare disease

Eligibility Criteria

Age3 Months - 4 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Infants with moderate to large ventricular septal defect (VSD) by most recent echocardiogram who meet the following conditions: no other concurrent heart or lung disease; no chromosomal defects or congenital anomalies OR Healthy control infants without VSD who meet the following conditions: clinically well; no heart disease; no chromosomal defects or congenital anomalies --Prior/Concurrent Therapy-- Surgery: VSD infants -- No prior cardiac surgery or palliative procedures; VSD and control infants -- Greater than 6 weeks since other prior surgery Other: VSD and control infants: Greater than 6 weeks since prior hospitalization

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Indiana University

Indianapolis, Indiana, 46202-5167, United States

RECRUITING

MeSH Terms

Conditions

Heart Septal Defects, VentricularRespiratory Tract DiseasesRare Diseases

Condition Hierarchy (Ancestors)

Heart Septal DefectsHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Catherine A. Leitch

    Indiana University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
NATURAL HISTORY
Sponsor Type
NIH

Study Record Dates

First Submitted

September 11, 2000

First Posted

September 12, 2000

Study Start

August 1, 1994

Last Updated

June 24, 2005

Record last verified: 2003-12

Locations

US(1)