Heart Septal Defects, VentricularNCT00006272
Study of Energy Expenditure in Infants With Ventricular Septal Defects
An observational study of Heart Septal Defects, Ventricular, run by National Center for Research Resources (NCRR) at 1 site in United States.
Trial summary
OBJECTIVES: I. Compare the total daily energy expenditure in infants with ventricular septal defects vs healthy control infants. Read more about this study
- Who is it for?
- Ages 3 to 4 monthsHealthy volunteers can take part
- Conditions the study is for
- Heart Septal Defects, Ventricular
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 1994to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 4 months
- All sexes
- Healthy volunteers accepted
- Child
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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Indiana University
Indianapolis, Indiana, 46202-5167
Catherine A. Leitch, 317-274-4920
About this study
OBJECTIVES:
- Compare the total daily energy expenditure in infants with ventricular septal defects vs healthy control infants.
Read the 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.
- Conditions
- Heart Septal Defects, Ventricular
- Keywords
- cardiovascular and respiratory diseases, heart defects, rare disease
- Medical subject headings
- Heart Septal Defects, Ventricular, Respiratory Tract Diseases, Rare Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2000 (estimated)
- Study startAug 1994
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Septal Defects, VentricularStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Natural history
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- National Center for Research Resources (NCRR)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Indiana University
- Investigators
- Catherine A. Leitch, Study chair, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006272
- Sponsor's protocol ID
- NCRR-M01RR00750-9045
- Other IDs
- IU-9607-08, IU-9511-16
- Status last verified
- Dec 2003
- First submitted
- 11 Sep 2000
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Energy Expenditure in Infants With Ventricular Septal Defects
- ClinicalTrials.gov ID
- NCT00006272
- Acronym / sponsor ID
- NCRR-M01RR00750-9045
- Conditions
- Heart Septal Defects, Ventricular
- Keywords
- cardiovascular and respiratory diseases, heart defects, rare disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants
- Lead sponsor
- National Center for Research Resources (NCRR)US National Institutes of Health
- Collaborators
- Indiana University
- Study start
- Aug 1994
- First posted
- 12 Sep 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
OBJECTIVES:
- 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.
Study design
- Observational model
- Natural history
Who may qualify
- Ages
- 3 to 4 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine A. Leitch study chair
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Septal Defects, Ventricular, run by National Center for Research Resources (NCRR) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.