Human Milk Fortification in Very Low Birth Neonates

Enteral Nutrition Clinical Trial

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

Status Completed

Clinical Trial Summary

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

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Enteral Nutrition
• Fortification
• Human Milk
• Premature; Infant

• NCT number: NCT01988792
• Study type: Interventional
• Source: University of Tennessee
• Status: Completed
• Phase: N/A
• Start date: November 2013
• Completion date: April 2015