Human Milk Fortification in Very Low Birth Neonates

Not Applicable

Completed

• Conditions: Human Milk; Premature; Infant; Fortification; Enteral Nutrition
• Interventions: Dietary Supplement: Human milk fortifiers

• Registration Number: NCT01988792
• Lead Sponsor: University of Tennessee

Brief Summary

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

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 Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-12
• Study First Submitted QC: 2013-11-13
• Study First Posted: 2013-11-20
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-28
• Last Update Posted: 2015-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fortification at 20 ml/kg/day feeding volume	Human milk fortifiers	Human milk fortifiers will be added to the human milk when neonates reach to feeding volume of 20 ml/kg/day.
Fortification at 100 ml/kg/day feeding volume	Human milk fortifiers	human milk fortifiers will be added to the human milk when neonates reach to feeding volume of 100 ml/kg/day.

Primary Outcome Measures

Name	Time	Method
The days to reach full enteral feeding volume (140 ml/kg/day).	4 - 6 weeks

Secondary Outcome Measures

Name	Time	Method
Neonatal Outcomes	until 4 weeks of life	Growth anthropometry

Trial Locations

Locations (1)

University of Tennessee, Health Science Center, The Regional Medical Center; 🇺🇸 Memphis, Tennessee, United States