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Infant Feeding Study.09-68

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Children's Hospital Medical Center, Cincinnati.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT01233427
First received: November 2, 2010
Last updated: November 11, 2010
Last verified: November 2010
History of Changes
  Purpose

Characterize a population-based sample of first-time expectant mothers with regards to maternal metabolic health and their infant feeding experience.


Condition
Describe the Infant Feeding Attitudes
Intentions of a Sample of Expectant First-time Mothers
Estimate the Prevalence of Early Lactation Difficulties

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: The Infant Feeding Experience of New Mothers - a Descriptive Pilot Study.

Resource links provided by NLM:

MedlinePlus related topics: Breast Feeding
U.S. FDA Resources

Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:
  • Early lactation difficulties [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    a)Estimate the prevalence of early lactation difficulties among the subset of this sample that initiates breastfeeding, b) examine the relationship between metabolic health and lactation difficulties


Secondary Outcome Measures:
  • Infant feeding attitudes [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    describe the prenatal infant feeding attitudes and intentions of a sample of expectant mothers from the same recruitment base as the future intervention trial


Biospecimen Retention:   Samples Without DNA

Blood (serum)


Estimated Enrollment: 32
Study Start Date: June 2009
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Detailed Description:

The long range purpose of this pilot study is to inform the development of an NIH-funded randomized intervention trial designed to improve early breastfeeding outcomes for mothers planning to breastfeed. The purpose of the pilot study is to 1) described the prenatal infant feeding attitudes and intentions of population-based sample of expectant mothers from the same recruitment base as the future intervention trial, 2) characterize the metabolic health profiles of the sample and 3) estimate the prevalence of early lactation difficulties among the subset of this sample that initiates breastfeeding.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

breastfeeding moms

Criteria

Inclusion Criteria:

  • First-time expectant mother, speaks English, receiving OB care at designated practice group

Exclusion Criteria:

  • 1) Under 18 years old; 2)no access to local telephone 3) multiple gestation 4) history of major breast surgery
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01233427

Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
Principal Investigator: Laurie A Nommsen-Rivers, PhD Children's Hospital Medical Center, Cincinnati
  More Information

No publications provided by Children's Hospital Medical Center, Cincinnati

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Laurie A. Nommsen-Rivers, Cincinnati Children's Hospital Medical Center
ClinicalTrials.gov Identifier: NCT01233427     History of Changes
Other Study ID Numbers: 09-68
Study First Received: November 2, 2010
Last Updated: November 11, 2010
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 23, 2013