NCT00616083

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
190

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2006

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 15, 2008

Completed
Last Updated

August 20, 2009

Status Verified

August 1, 2009

Enrollment Period

1.2 years

First QC Date

February 5, 2008

Last Update Submit

August 19, 2009

Conditions

Healthy

Keywords

Breast FeedingBody CompositionBody FatInfantDietHealthy Infants

Study Arms (1)

1

Healthy breast fed infants

Eligibility Criteria

AgeUp to 2 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Helathy breast fed infats, less than a week old living in the Little Rock area.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Arkansas Children's Nutrition Center

Little Rock, Arkansas, 72202, United States

Location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

University of Oklahoma Health Science Center

Oklahoma City, Oklahoma, 73104, United States

Location

Universita degli Studi di Milano

Milan, Italy

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Aline Andres, Ph.D.

    University of Arkansas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 5, 2008

First Posted

February 15, 2008

Study Start

April 1, 2006

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

August 20, 2009

Record last verified: 2009-08

Locations

US(3)IT(1)