HealthyPeaPodNCT00616083
Percent Body Fat in Breast Fed Infants
An observational study of Healthy, run by Arkansas Children's Hospital Research Institute at 4 sites in 2 countries.
Trial summary
The purpose of this study is to learn about normal body composition (% body fat) during the first six months of life in healthy breast-fed babies. Read more about this study
- Who is it for?
- Ages Up to 2 weeks
- Conditions the study is for
- Healthy
- How many people
- 190 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Apr 2006to Jul 2007
- 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 Up to 2 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Helathy breast fed infats, less than a week old living in the Little Rock area.
Who may be able to join
- Term birth
- Infant must weigh at least 5.5# at birth
- Single birth
- Healthy mother/infant as determined by the investigator
- Intention to breast feed
Who cannot join
- Significant perinatal morbidity
- Having health, environmental, or economic constraints on growth
- Infants of a mother with diabetes or gestational diabetes
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
MetroHealth Medical Center
Cleveland, Ohio, 44109
Arkansas Children's Nutrition Center
Little Rock, Arkansas, 72202
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, 73104
About this study
Official title: Developing Normative Body Composition Data in Early Infancy
The purpose of this study is to learn about normal body composition (% body fat) during the first six months of life in healthy breast-fed babies.
- Conditions
- Healthy
- Keywords
- Breast Feeding, Body Composition, Body Fat, Infant, Diet, Healthy Infants
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Healthy breast fed infants |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2008 (estimated)
- Study startApr 2006
- Primary completionJul 2007
- Study completionJul 2007
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
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arkansas Children's Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of Arkansas, United States Department of Agriculture (USDA), Life Measurement Inc., University of Oklahoma, MetroHealth Medical Center, University of Milan
- Investigators
- Aline Andres, Ph.D., Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00616083
- Sponsor's protocol ID
- 56991
- Acronym
- PeaPod
- Status last verified
- Aug 2009
- First submitted
- 5 Feb 2008
- Last updated
- 20 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Normative Body Composition Data in Early Infancy
- ClinicalTrials.gov ID
- NCT00616083
- Acronym / sponsor ID
- PeaPod / 56991
- Conditions
- Healthy
- Keywords
- Breast Feeding, Body Composition, Body Fat, Infant, Diet, Healthy Infants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Arkansas Children's Hospital Research InstituteUniversity, hospital or other
- Collaborators
- University of Arkansas, United States Department of Agriculture (USDA), Life Measurement Inc., University of Oklahoma, MetroHealth Medical Center, University of Milan
- Study start
- Apr 2006
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 15 Feb 2008 (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.
The purpose of this study is to learn about normal body composition (% body fat) during the first six months of life in healthy breast-fed babies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Healthy breast fed infants |
Who may qualify
- Ages
- Up to 2 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Helathy breast fed infats, less than a week old living in the Little Rock area.
Key inclusion criteria (5 listed)
- Term birth
- Infant must weigh at least 5.5# at birth
- Single birth
- Healthy mother/infant as determined by the investigator
- Intention to breast feed
Key exclusion criteria (3 listed)
- Significant perinatal morbidity
- Having health, environmental, or economic constraints on growth
- Infants of a mother with diabetes or gestational diabetes
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 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 20 Aug 2009.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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, Ph.D. principal investigator
University of Arkansas
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Arkansas Children's Hospital Research Institute at 4 sites in 2 countries.
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 5 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: finished, as of the sponsor's last update on 20 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Italy. 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?
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.
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 Aug 2009.