Nutritional Content of Breast Milk From Mothers of Premies

This study has been terminated.
(Lack of enrollment)
Sponsor:
Collaborator:
Prolacta Bioscience
Information provided by:
Pediatrix Medical Group
ClinicalTrials.gov Identifier:
NCT01050192
First received: January 13, 2010
Last updated: October 5, 2010
Last verified: October 2010

January 13, 2010
October 5, 2010
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01050192 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Neonatal Intensive Care Unit

  • Prematurity
  • Nutrition
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
64
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
Both
23 Weeks to 30 Weeks
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01050192
Pro0001271
No
Reese H Clark, Pediatrix Medical Group
Pediatrix Medical Group
Prolacta Bioscience
Principal Investigator: Reese Clark, MD Greenville Memorial Hospital
Pediatrix Medical Group
October 2010

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