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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00783770
Other study ID # 31247
Secondary ID
Status Completed
Phase N/A
First received October 31, 2008
Last updated May 16, 2011
Start date July 2005

Study information

Verified date May 2011
Source Arkansas Children's Hospital Research Institute
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

Mother's breast milk provides many benefits to babies with regard to development and improved health. We believe the simple sugars which make up these complex sugars in breast milk and are also found in the brain may be critical to normal brain development in term and preterm infants.

Babies are exposed to these sugars by placental transport during pregnancy and through mother's breast milk after they are born. For the preterm infant, we do not know if breast milk gives enough of these sugars compared to what the baby gets during pregnancy.

A maternal blood sample and blood samples from the baby's umbilical cord will provide us with background information for developing a supplement of special sugars that can be added to infant formulas to provide the amount that the baby usually gets during pregnancy and from breast milk.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date
Est. primary completion date March 2007
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria:

- Healthy mothers with ages ranging from 18 to 35 yrs

- Delivered infants appropriate weight for gestational age (between 10% and 90%)

Exclusion Criteria:

- Maternal history of smoking, alcohol or drug use

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
Arkansas Children's Hospital Research Institute United States Department of Agriculture (USDA), University of Arkansas
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