Human Milk Fortification in Very Low Birth Neonates

July 28, 2015 updated by: University of Tennessee

Human Milk Fortification and Feeding Intolerance in Very Low Birth Weight Neonates

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Memphis, Tennessee, United States, 38163
        • University of Tennessee, Health Science Center, The Regional Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 days to 1 week (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The days to reach full enteral feeding volume (140 ml/kg/day).
Time Frame: 4 - 6 weeks
4 - 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neonatal Outcomes
Time Frame: until 36 weeks PMA
Necrotizing Enterocolitis
until 36 weeks PMA
Neonatal Outcomes
Time Frame: until 36 weeks PMA
Chronic Lung Disease
until 36 weeks PMA
Neonatal Outcomes
Time Frame: Until full feeding volume
Feeding intolerance
Until full feeding volume
Neonatal Outcomes
Time Frame: Until full feeding volume
Parental nutrition days
Until full feeding volume
Neonatal Outcomes
Time Frame: until 36 weeks PMA
Ventilator days
until 36 weeks PMA
Neonatal Outcomes
Time Frame: until 4 weeks of life
Protein and caloric intake
until 4 weeks of life
Neonatal Outcomes
Time Frame: until 4 weeks of life
Growth anthropometry
until 4 weeks of life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Tennessee

Investigators

  • Principal Investigator: Sanket D Shah, MBBS, UTHSC, Memphis, TN
  • Principal Investigator: Ajay J Talati, MD, UTHSC, Memphis, TN

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

November 12, 2013

First Submitted That Met QC Criteria

November 13, 2013

First Posted (Estimate)

November 20, 2013

Study Record Updates

Last Update Posted (Estimate)

July 29, 2015

Last Update Submitted That Met QC Criteria

July 28, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 13-02741-FB
  • 8671-2075 (Other Grant/Funding Number: Mead Johnson and Company LLC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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