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Percent Body Fat in Breast Fed Infants (PeaPod)

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ClinicalTrials.gov Identifier: NCT00616083
Recruitment Status : Completed
First Posted : February 15, 2008
Last Update Posted : August 20, 2009
Sponsor:
Collaborators:
University of Arkansas
United States Department of Agriculture (USDA)
Life Measurement Inc.
University of Oklahoma
MetroHealth Medical Center
University of Milan
Information provided by:
Arkansas Children's Hospital Research Institute

Brief 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.

Condition or disease
Healthy

Study Type : Observational
Actual Enrollment : 190 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Developing Normative Body Composition Data in Early Infancy
Study Start Date : April 2006
Actual Primary Completion Date : July 2007
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding
U.S. FDA Resources

Group/Cohort
1
Healthy breast fed infants




Information from the National Library of Medicine

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Ages Eligible for Study:   up to 2 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Helathy breast fed infats, less than a week old living in the Little Rock area.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Significant perinatal morbidity
  • Having health, environmental, or economic constraints on growth
  • Infants of a mother with diabetes or gestational diabetes

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00616083


Locations
United States, Arkansas
Arkansas Children's Nutrition Center
Little Rock, Arkansas, United States, 72202
United States, Ohio
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
United States, Oklahoma
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, United States, 73104
Italy
Universita degli Studi di Milano
Milano, Italy
Sponsors and Collaborators
Arkansas Children's Hospital Research Institute
University of Arkansas
United States Department of Agriculture (USDA)
Life Measurement Inc.
University of Oklahoma
MetroHealth Medical Center
University of Milan
Investigators
Principal Investigator: Aline Andres, Ph.D. University of Arkansas

Responsible Party: Aline Andres, Ph.D / Principal Investiagor, University of Arkansas for Medical Science
ClinicalTrials.gov Identifier: NCT00616083     History of Changes
Other Study ID Numbers: 56991
First Posted: February 15, 2008    Key Record Dates
Last Update Posted: August 20, 2009
Last Verified: August 2009

Keywords provided by Arkansas Children's Hospital Research Institute:
Breast Feeding
Body Composition
Body Fat
Infant
Diet
Healthy Infants