Study of Energy Expenditure in Infants With Ventricular Septal Defects

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00006272

Enrollment

Registered

2000-09-12

Start date

1994-08-31

Completion date

Unknown

Last updated

2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Septal Defects, Ventricular

Keywords

cardiovascular and respiratory diseases, heart defects, rare disease

Brief summary

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

Detailed description

PROTOCOL OUTLINE: Height, weight, and vital signs (including oxygen saturation by pulse oximetry) are measured on Day 1. Resting energy expenditure, oxygen consumption (VO2), carbon dioxide production (VCO2), and resting respiratory exchange quotient (RQ) are measured using open circuit respiratory calorimetry on Day 1. Patients undergo assessment of total daily energy expenditure using the doubly labeled water method comprised of oral deuterium and oral oxygen O 18 with the next scheduled feeding on Day 1. Urine samples are collected prior to isotope administration, then serially for approximately 12 hours after isotope administration on Day 1, and then daily on Days 2-7. These samples are analyzed by mass spectrometry. On Day 1, patients also undergo echocardiogram to confirm size of defect and measure the degree of pulmonary/systemic blood flow ratio and pulmonary artery pressures.

Interventions

None listed

Study design

Observational model

NATURAL_HISTORY

Eligibility

Sex/Gender

ALL

Age

3 Months to 4 Months

Healthy volunteers

Yes

Inclusion criteria

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

Countries

United States

Outcome results