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NCT01050192 Clinical Trial

Nutritional Content of Breast Milk From Mothers of Premies

Prematurity Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01050192
Other study ID # Pro0001271
Secondary ID
Status Withdrawn
Phase N/A
First received January 13, 2010
Last updated March 21, 2017
Start date December 2009
Est. completion date September 2010

Study information
Verified date March 2017
Source Mednax Center for Research, Education and Quality
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date September 2010
Est. primary completion date September 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 23 Weeks to 30 Weeks
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Greenville Memorial Hospital Greenville South Carolina

Sponsors (2)
Lead Sponsor Collaborator
Mednax Center for Research, Education and Quality Prolacta Bioscience

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 28 days of life
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