Human Milk Fortification in Very Low Birth Neonates

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)

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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