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NCT00601081 Clinical Trial

Human Milk Fortifier and Cytokine Profile

Infant, Very Low Birth Weight Clinical Trial

Official title:
Alterations in the Cytokine Profile of Premature Infants After Human Milk Fortifier

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00601081
Other study ID # 27127
Secondary ID
Status Completed
Phase N/A
First received January 15, 2008
Last updated May 9, 2017
Start date November 2007
Est. completion date June 2008

Study information
Verified date May 2017
Source Christiana Care Health Services
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date June 2008
Est. primary completion date June 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 6 Months
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
United States Christiana Hospital Newark Delaware

Sponsors (1)
Lead Sponsor Collaborator
Christiana Care Health Services

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cytokine profile pre and post initiation of HMF up to 14 days
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