Nutritional Content of Breast Milk From Mothers of Premies

This study has been terminated.
(Lack of enrollment)
Sponsor:
Collaborator:
Prolacta Bioscience
Information provided by:
Pediatrix Medical Group
ClinicalTrials.gov Identifier:
NCT01050192
First received: January 13, 2010
Last updated: October 5, 2010
Last verified: October 2010
  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 Pediatrix Medical Group:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 64
Study Start Date: December 2009
Study Completion Date: September 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   23 Weeks to 30 Weeks
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01050192

Locations
United States, South Carolina
Greenville Memorial Hospital
Greenville, South Carolina, United States
Sponsors and Collaborators
Pediatrix Medical Group
Prolacta Bioscience
Investigators
Principal Investigator: Reese Clark, MD Greenville Memorial Hospital
  More Information

No publications provided

Responsible Party: Reese H Clark, Pediatrix Medical Group
ClinicalTrials.gov Identifier: NCT01050192     History of Changes
Other Study ID Numbers: Pro0001271
Study First Received: January 13, 2010
Last Updated: October 5, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Pediatrix Medical Group:
Prematurity
Nutrition
Breast Feeding

ClinicalTrials.gov processed this record on October 19, 2014