Nutritional Content of Breast Milk From Mothers of Premies

NCT ID: NCT01050192

Last Updated: 2017-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2009-12-31

Study Completion Date

2010-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Prematurity Nutrition

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

23 Weeks

Maximum Eligible Age

30 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Prolacta Bioscience

INDUSTRY

Sponsor Role collaborator

Pediatrix

OTHER

Sponsor Role lead

Responsible Party

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Amy Kelleher

Director Clinical Trial Operations

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Reese Clark, MD

Role: PRINCIPAL_INVESTIGATOR

Greenville Memorial Hospital

Locations

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Greenville Memorial Hospital

Greenville, South Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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Pro0001271

Identifier Type: -

Identifier Source: org_study_id

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