ClinicalTrials.Veeva

Menu

Human Milk Fortification in Very Low Birth Neonates

University of Tennessee logo

University of Tennessee

Status

Completed

Conditions

Human Milk
Premature; Infant
Enteral Nutrition
Fortification

Treatments

Dietary Supplement: Human milk fortifiers

Study type

Interventional

Funder types

Other

Identifiers

NCT01988792
8671-2075 (Other Grant/Funding Number)
13-02741-FB

Details and patient eligibility

About

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

Full 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.

Enrollment

100 patients

Sex

All

Ages

2 to 7 days old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups

Fortification at 20 ml/kg/day feeding volume
Active Comparator group
Description:
Human milk fortifiers will be added to the human milk when neonates reach to feeding volume of 20 ml/kg/day.
Treatment:
Dietary Supplement: Human milk fortifiers
Fortification at 100 ml/kg/day feeding volume
Active Comparator group
Description:
human milk fortifiers will be added to the human milk when neonates reach to feeding volume of 100 ml/kg/day.
Treatment:
Dietary Supplement: Human milk fortifiers

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems