Human Milk Fortification in Very Low Birth Neonates

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Sanket D. Shah, MBBS, University of Tennessee Identifier:
First received: November 12, 2013
Last updated: January 27, 2015
Last verified: January 2015

The purpose of this study to find out how safely we can add extra nutrients to human milk at different feeding volume.

Condition Intervention
Premature; Infant
Enteral Nutrition
Human Milk
Dietary Supplement: Human milk fortifiers

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Human Milk Fortification and Feeding Intolerance in Very Low Birth Weight Neonates

Further study details as provided by University of Tennessee:

Primary Outcome Measures:
  • The days to reach full enteral feeding volume (140 ml/kg/day). [ Time Frame: 4 - 6 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: November 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Fortification at 20 ml/kg/day feeding volume
Human milk fortifiers will be added to the human milk when neonates reach to feeding volume of 20 ml/kg/day.
Dietary Supplement: Human milk fortifiers
Active Comparator: Fortification at 100 ml/kg/day feeding volume
human milk fortifiers will be added to the human milk when neonates reach to feeding volume of 100 ml/kg/day.
Dietary Supplement: Human milk fortifiers

Detailed Description:

Very low birth weight babies (weight less than three pounds and three ounces) are extremely fragile and lacking important nutrition due to premature birth. They need enough calories for catch-up growth. Giving adequate nutrition is very important for their growth and development. Human milk is the best food, however it is not enough to provide all the required calories and nutrients for catch up growth and maintain adequate strength of the bones (bone mineralization). For premature babies, extra nutrients (human milk fortifier) are usually added to the human milk to provide adequate nutrition. These extra nutrients will be derived from cow's milk. Currently, a practice of fortifying human milk varies. There is no clear information when to start adding extra nutrients to human milk.


Ages Eligible for Study:   up to 7 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Very low birth weight infants who receive human milk (mother's milk or banked donor human milk).

Exclusion Criteria:

  • Major congenital anomalies such as cardiac defect, neural tube defect, chromosomal abnormality and gastrointestinal defect.
  • Died within 48 hours of life
  Contacts and Locations
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Please refer to this study by its identifier: NCT01988792

United States, Tennessee
University of Tennessee, Health Science Center, The Regional Medical Center
Memphis, Tennessee, United States, 38163
Sponsors and Collaborators
University of Tennessee
Principal Investigator: Sanket D Shah, MBBS UTHSC, Memphis, TN
Principal Investigator: Ajay J Talati, MD UTHSC, Memphis, TN
  More Information

No publications provided

Responsible Party: Sanket D. Shah, MBBS, Neonatal Perinatal Medicine Fellow, University of Tennessee Identifier: NCT01988792     History of Changes
Other Study ID Numbers: 13-02741-FB, 8671-2075
Study First Received: November 12, 2013
Last Updated: January 27, 2015
Health Authority: United States: Institutional Review Board processed this record on May 21, 2015