Human Milk Fortifier and Cytokine Profile - Full Text View

Purpose

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

Condition

Infant, Very Low Birth Weight

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective

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

Further study details as provided by Christiana Care Health Services:

Primary Outcome Measures:

Cytokine profile pre and post initiation of HMF [ Time Frame: up to 14 days ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

Blood and stool

Enrollment:	24
Study Start Date:	November 2007
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts

1

Very low birth weight and preterm infants who will likely receive fortification of breast milk with HMF

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.

Eligibility

Ages Eligible for Study:	up to 6 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Infants hospitalized in the newborn intensive care unit.

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00601081

Locations


United States, Delaware
	Christiana Hospital
	Newark, Delaware, United States, 19718

Sponsors and Collaborators

Christiana Care Health Services

Investigators


Principal Investigator:	Robert G. Locke, DO	Christiana Hospital

Principal Investigator:	Christopher T. Hsu, MD	Christiana Hospital

More Information

Responsible Party:	Christiana Hospital ( Christopher Hsu, MD )
Study ID Numbers:	27127
First Received:	January 15, 2008
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00601081
Health Authority:	United States: Institutional Review Board

Keywords provided by Christiana Care Health Services:

Very low birth weight infants

HMF

immune system function

Study placed in the following topic categories:

Body Weight

Birth Weight

Signs and Symptoms

ClinicalTrials.gov processed this record on October 28, 2008

Sponsored by:	Christiana Care Health Services
Information provided by:	Christiana Care Health Services
ClinicalTrials.gov Identifier:	NCT00601081