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Nutritional Content of Breast Milk From Mothers of Premies

This study has been withdrawn prior to enrollment.
(Lack of enrollment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01050192
First Posted: January 15, 2010
Last Update Posted: March 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Prolacta Bioscience
Information provided by (Responsible Party):
Amy Kelleher, Mednax Center for Research, Education and Quality
  Purpose
The purpose of this study is to determine the correlation, if any, between the nutritional content of breast milk pumped by the mothers of very low birth weight (VLBW) infants in the neonatal intensive care unit (NICU) and the nutritional value they are actually receiving in a 24 hour period, since as a practical matter, these may not be the same.

Condition
Prematurity Nutrition

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Nutritional Content of Breast Milk From Mothers of Premature Neonates During the First 28 Days of Life

Further study details as provided by Amy Kelleher, Mednax Center for Research, Education and Quality:

Primary Outcome Measures:
  • To determine the correlation, if any, between the nutritional content of breast milk pumped by the mothers of VLBW infants in the NICU and the nutritional value they are actually receiving in a 24 hour period. [ Time Frame: 28 days of life ]

Enrollment: 0
Study Start Date: December 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   23 Weeks to 30 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Neonatal Intensive Care Unit
Criteria

Inclusion Criteria:

  • Mothers of infants with a gestational age <=30 weeks in the NICU who are supplying their own breast milk for use by their baby
  • Reasonable likelihood of survival of infant to 28 days
  • Infant on/ready for oral feeding by DOL 7 days
  • Willing to provide breast milk for their baby
  • Able to produce at least 7mL breast milk per feeding
  • Willing to abide by requirements of the study protocol
  • Documentation of informed consent

Exclusion Criteria:

  • Unable to provide at least 7mL breast milk per feeding
  • Medically unsuitable to provide breast milk to her baby
  • Maternal age <18 years of age
  Contacts and Locations
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): NCT01050192


Locations
United States, South Carolina
Greenville Memorial Hospital
Greenville, South Carolina, United States
Sponsors and Collaborators
Mednax Center for Research, Education and Quality
Prolacta Bioscience
Investigators
Principal Investigator: Reese Clark, MD Greenville Memorial Hospital
  More Information

Responsible Party: Amy Kelleher, Director Clinical Trial Operations, Mednax Center for Research, Education and Quality
ClinicalTrials.gov Identifier: NCT01050192     History of Changes
Other Study ID Numbers: Pro0001271
First Submitted: January 13, 2010
First Posted: January 15, 2010
Last Update Posted: March 23, 2017
Last Verified: March 2017

Keywords provided by Amy Kelleher, Mednax Center for Research, Education and Quality:
Prematurity
Nutrition
Breast Feeding

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications