Infant Body Composition and MetabolismNCT01464684
Body Composition of Infants: Follow-up to Placenta and Cord Blood Analyses
An observational study of Infant Body Composition and Metabolism, run by University of Arkansas.
Trial summary
Investigators will characterize the body composition and metabolism of infants born from lean, overweight or obese mothers from whom they had previously obtained a placenta and/or cord blood as part of the earlier placenta and cord blood study (#111576) Read more about this study
- Who is it for?
- Ages 3 to 21 monthsHealthy volunteers can take part
- Conditions the study is for
- Infant Body Composition and Metabolism
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2011to Dec 2012
- 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 21 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: infants age 12 months (+/- 9 months)
Who may be able to join
- mother's prior participation in study #111576 with successful collection of placenta
- infant age 12 months (+/- 9 months)
Who cannot join
- mother did not participate in study #111576
- mother did participate in study #111576, but collection of placenta was not successful
- infant not age 12 months (+/- 9 months)
About this study
Investigators will characterize the body composition and metabolism of infants born from lean, overweight or obese mothers from whom they had previously obtained a placenta and/or cord blood as part of the earlier placenta and cord blood study (#111576)
- Conditions
- Infant Body Composition and Metabolism
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2011 (estimated)
- Study startOct 2011
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Why it stopped: determined not enough participants would be able to be enrolled and not enough data collected for good analyses
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant Body Composition and MetabolismStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aline Andres, PhD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01464684
- Sponsor's protocol ID
- 132624
- Status last verified
- Apr 2017
- First submitted
- 31 Oct 2011
- Last updated
- 20 Apr 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body Composition of Infants: Follow-up to Placenta and Cord Blood Analyses
- ClinicalTrials.gov ID
- NCT01464684
- Acronym / sponsor ID
- 132624
- Conditions
- Infant Body Composition and Metabolism
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: determined not enough participants would be able to be enrolled and not enough data collected for good analyses
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 3 Nov 2011 (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.
Investigators will characterize the body composition and metabolism of infants born from lean, overweight or obese mothers from whom they had previously obtained a placenta and/or cord blood as part of the earlier placenta and cord blood study (#111576)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 to 21 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- infants age 12 months (+/- 9 months)
Key inclusion criteria (2 listed)
- mother's prior participation in study #111576 with successful collection of placenta
- infant age 12 months (+/- 9 months)
Key exclusion criteria (3 listed)
- mother did not participate in study #111576
- mother did participate in study #111576, but collection of placenta was not successful
- infant not age 12 months (+/- 9 months)
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
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2017.
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RecruitingObservational study
Studying Phenotypic Risks for Obesity and Underlying Traits in Young Infants
Infant Body Composition and Metabolism, Metabolism
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.
Aline Andres, PhD principal investigator
University of Arkansas
Questions about this trial
What is this clinical trial studying?
An observational study of Infant Body Composition and Metabolism, run by University of Arkansas.
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 2 inclusion and 3 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: withdrawn, as of the sponsor's last update on 20 Apr 2017. 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 was withdrawn before enrolling participants, so there are no results.
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.
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 20 Apr 2017; AzTrials last refreshed its copy on 8 Nov 2026.