Human Milk Fortification in Very Low Birth Neonates

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Tennessee
ClinicalTrials.gov Identifier:
NCT01988792
First received: November 12, 2013
Last updated: July 28, 2015
Last verified: July 2015
  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
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 ]

Secondary Outcome Measures:
  • Neonatal Outcomes [ Time Frame: until 36 weeks PMA ] [ Designated as safety issue: Yes ]
    Necrotizing Enterocolitis

  • Neonatal Outcomes [ Time Frame: until 36 weeks PMA ] [ Designated as safety issue: No ]
    Chronic Lung Disease

  • Neonatal Outcomes [ Time Frame: Until full feeding volume ] [ Designated as safety issue: Yes ]
    Feeding intolerance

  • Neonatal Outcomes [ Time Frame: Until full feeding volume ] [ Designated as safety issue: No ]
    Parental nutrition days

  • Neonatal Outcomes [ Time Frame: until 36 weeks PMA ] [ Designated as safety issue: No ]
    Ventilator days

  • Neonatal Outcomes [ Time Frame: until 4 weeks of life ] [ Designated as safety issue: No ]
    Protein and caloric intake

  • Neonatal Outcomes [ Time Frame: until 4 weeks of life ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   up to 7 Days
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University of Tennessee
ClinicalTrials.gov Identifier: NCT01988792     History of Changes
Other Study ID Numbers: 13-02741-FB, 8671-2075
Study First Received: November 12, 2013
Last Updated: July 28, 2015
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on August 03, 2015