HealthyNCT01905085
Energy Expenditure Methodology Infant
An observational study of Healthy, run by Arkansas Children's Hospital Research Institute.
Trial summary
Indirect calorimetry is valuable in determining resting energy expenditure in infants, children and adults. This measure will estimate the number of calories needed per day under resting conditions. Adding physical activity measures will help estimate total energy requirements in individuals. Read more about this study
- Who is it for?
- Ages 3 to 3 monthsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Nov 2011to Sep 2014
- 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 3 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Healthy infants
Who may be able to join
- 3 months old +/- 2 weeks
- Can fall asleep easily
- Usually sleeps more than 30 min
- Accept formula as an alternative feeding
Who cannot join
- Pulmonary or respiratory disorders
About this study
Indirect calorimetry is valuable in determining resting energy expenditure in infants, children and adults. This measure will estimate the number of calories needed per day under resting conditions.
Adding physical activity measures will help estimate total energy requirements in individuals. With the rise in obesity, numerous programs of prevention are being developed. Being able to characterize carefully energy intake and energy expenditure is one of the challenges of most of these initiatives.
- Conditions
- Healthy
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure Resting energy expenditure in infants
We will measure resting energy expenditure in infants and then they will come back for a second visit and get the same measurement to see if there is a significant difference between the two measures.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2013 (estimated)
- Study startNov 2011
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arkansas Children's Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01905085
- Sponsor's protocol ID
- 133331
- Status last verified
- Sep 2015
- First submitted
- 9 Jul 2013
- Last updated
- 10 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Energy Expenditure Methodology Infant
- ClinicalTrials.gov ID
- NCT01905085
- Acronym / sponsor ID
- 133331
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Arkansas Children's Hospital Research InstituteUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 23 Jul 2013 (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.
Indirect calorimetry is valuable in determining resting energy expenditure in infants, children and adults. This measure will estimate the number of calories needed per day under resting conditions.
Adding physical activity measures will help estimate total energy requirements in individuals. With the rise in obesity, numerous programs of prevention are being developed. Being able to characterize carefully energy intake and energy expenditure is one of the challenges of most of these initiatives.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 to 3 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Healthy infants
Key inclusion criteria (4 listed)
- 3 months old +/- 2 weeks
- Can fall asleep easily
- Usually sleeps more than 30 min
- Accept formula as an alternative feeding
Key exclusion criteria (1 listed)
- Pulmonary or respiratory disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention | Device | – |
Primary outcome
Measure Resting energy expenditure in infants
Time frame: 2 days
We will measure resting energy expenditure in infants and then they will come back for a second visit and get the same measurement to see if there is a significant difference between the two measures.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Arkansas Children's Hospital Research Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. 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: finished, as of the sponsor's last update on 10 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure Resting energy expenditure in infants (time frame: 2 days). It is what the study was designed to measure, not a finding.
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 10 Sep 2015.