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Human Milk Fortification in Very Low Birth Neonates

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01988792
First Posted: November 20, 2013
Last Update Posted: July 29, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Tennessee
  Purpose
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 Fortification Dietary Supplement: Human milk fortifiers

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • Neonatal Outcomes [ Time Frame: until 36 weeks PMA ]
    Necrotizing Enterocolitis

  • Neonatal Outcomes [ Time Frame: until 36 weeks PMA ]
    Chronic Lung Disease

  • Neonatal Outcomes [ Time Frame: Until full feeding volume ]
    Feeding intolerance

  • Neonatal Outcomes [ Time Frame: Until full feeding volume ]
    Parental nutrition days

  • Neonatal Outcomes [ Time Frame: until 36 weeks PMA ]
    Ventilator days

  • Neonatal Outcomes [ Time Frame: until 4 weeks of life ]
    Protein and caloric intake

  • Neonatal Outcomes [ Time Frame: until 4 weeks of life ]
    Growth anthropometry


Enrollment: 100
Study Start Date: November 2013
Study Completion Date: April 2015
Primary Completion Date: April 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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 7 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 or extended to die within 48 hours of life
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01988792


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Tennessee
ClinicalTrials.gov Identifier: NCT01988792     History of Changes
Other Study ID Numbers: 13-02741-FB
8671-2075 ( Other Grant/Funding Number: Mead Johnson and Company LLC )
First Submitted: November 12, 2013
First Posted: November 20, 2013
Last Update Posted: July 29, 2015
Last Verified: July 2015