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Clinical Trials/NCT01050192
NCT01050192
Withdrawn
Not Applicable

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

Pediatrix1 site in 1 countryDecember 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prematurity
Sponsor
Pediatrix
Locations
1
Primary Endpoint
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.
Status
Withdrawn
Last Updated
9 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
December 2009
End Date
September 2010
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Pediatrix
Responsible Party
Principal Investigator
Principal Investigator

Amy Kelleher

Director Clinical Trial Operations

Pediatrix

Eligibility 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

Outcomes

Primary Outcomes

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

Study Sites (1)

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