Nutritional Content of Breast Milk From Mothers of Premies

March 21, 2017 updated by: Amy Kelleher, Pediatrix

The Nutritional Content of Breast Milk From Mothers of Premature Neonates During the First 28 Days of Life

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.

Study Overview

Status

Withdrawn

Conditions

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Greenville, South Carolina, United States
        • Greenville Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 months to 6 months (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Neonatal Intensive Care Unit

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
28 days of life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pediatrix

Collaborators

Prolacta Bioscience

Investigators

  • Principal Investigator: Reese Clark, MD, Greenville Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (ACTUAL)

September 1, 2010

Study Completion (ACTUAL)

September 1, 2010

Study Registration Dates

First Submitted

January 13, 2010

First Submitted That Met QC Criteria

January 14, 2010

First Posted (ESTIMATE)

January 15, 2010

Study Record Updates

Last Update Posted (ACTUAL)

March 23, 2017

Last Update Submitted That Met QC Criteria

March 21, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro0001271

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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