Human Milk Fortifier and Cytokine Profile

Completed

• Conditions: Infant, Very Low Birth Weight

• Registration Number: NCT00601081
• Lead Sponsor: Christiana Care Health Services

Brief Summary

This is a research study investigating if adding human milk fortifier to a preterm babies breast milk feedings affects the baby's immune system.

Detailed Description

In very low birth weight (VLBW) infants and preterm infants human milk fortifier (HMF) is often added to breast milk feedings in order to add extra calories, vitamins, and minerals. It is well known that breast milk feedings are easier to digest and have immune benefits compared to formula feedings. Cytokines, marker of immune function, can be found in blood, stool, and breast milk. This study involves collection of blood and stool samples to monitor cytokines. The purpose of this study is to understand whether human milk fortifier alters infants' cytokines.

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2008-01-15
• Study First Submitted QC: 2008-01-15
• Study First Posted: 2008-01-25
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-09
• Last Update Posted: 2017-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Infants born weighing less than 1500 grams
• exclusive breast milk feedings with intention to fortify with human milk fortifier

Exclusion Criteria

• positive blood culture
• history of necrotizing enterocolitis
• significant lung disease at the start of the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cytokine profile pre and post initiation of HMF	up to 14 days

Trial Locations

Locations (1)

Christiana Hospital; 🇺🇸 Newark, Delaware, United States