NCT00783770

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

October 31, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 3, 2008

Completed
Last Updated

May 18, 2011

Status Verified

May 1, 2011

Enrollment Period

1.7 years

First QC Date

October 31, 2008

Last Update Submit

May 16, 2011

Conditions

Keywords

BreastfeedingInfantPretermNutrition

Study Arms (3)

30-33 weeks

mother infant pairs with gestation of 30-33 weeks

34-37 weeks

mother infant pairs with gestation of 34-37 weeks

38-42 weeks

mother infant pairs with gestation of 38-42 weeks

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Twenty-four generally healthy mother-infant pairs.

You may qualify if:

  • Healthy mothers with ages ranging from 18 to 35 yrs
  • Delivered infants appropriate weight for gestational age (between 10% and 90%)

You may not qualify if:

  • Maternal history of smoking, alcohol or drug use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma will be stored

MeSH Terms

Conditions

Breast FeedingPremature Birth

Condition Hierarchy (Ancestors)

Feeding BehaviorBehaviorObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 31, 2008

First Posted

November 3, 2008

Study Start

July 1, 2005

Primary Completion

March 1, 2007

Last Updated

May 18, 2011

Record last verified: 2011-05