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Nutritional Content of Breast Milk From Mothers of Premies

This study has been withdrawn prior to enrollment.
(Lack of enrollment)
Sponsor:
Collaborator:
Prolacta Bioscience
Information provided by (Responsible Party):
Amy Kelleher, Mednax Center for Research, Education and Quality
ClinicalTrials.gov Identifier:
NCT01050192
First received: January 13, 2010
Last updated: March 21, 2017
Last verified: March 2017

January 13, 2010
March 21, 2017
December 2009
September 2010   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01050192 on ClinicalTrials.gov Archive Site
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Nutritional Content of Breast Milk From Mothers of Premies
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.
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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample
Neonatal Intensive Care Unit
  • Prematurity
  • Nutrition
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
September 2010
September 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
23 Weeks to 30 Weeks   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01050192
Pro0001271
No
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Amy Kelleher, Mednax Center for Research, Education and Quality
Mednax Center for Research, Education and Quality
Prolacta Bioscience
Principal Investigator: Reese Clark, MD Greenville Memorial Hospital
Mednax Center for Research, Education and Quality
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP