Human Milk Fortifier and Cytokine Profile

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00601081
Recruitment Status : Completed
First Posted : January 25, 2008
Last Update Posted : May 10, 2017
Information provided by (Responsible Party):
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.

Condition or disease
Infant, Very Low Birth Weight

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 Type : Observational
Actual Enrollment : 24 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Alterations in the Cytokine Profile of Premature Infants After Human Milk Fortifier
Study Start Date : November 2007
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Weight
U.S. FDA Resources

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

Primary Outcome Measures :
  1. Cytokine profile pre and post initiation of HMF [ Time Frame: up to 14 days ]

Biospecimen Retention:   Samples With DNA
Blood and stool

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Infants hospitalized in the newborn intensive care unit.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00601081

United States, Delaware
Christiana Hospital
Newark, Delaware, United States, 19718
Sponsors and Collaborators
Christiana Care Health Services
Principal Investigator: Robert G. Locke, DO Christiana Hospital
Principal Investigator: Christopher T. Hsu, MD Christiana Hospital

Responsible Party: Christiana Care Health Services Identifier: NCT00601081     History of Changes
Other Study ID Numbers: 27127
First Posted: January 25, 2008    Key Record Dates
Last Update Posted: May 10, 2017
Last Verified: May 2017

Keywords provided by Christiana Care Health Services:
Very low birth weight infants
immune system function

Additional relevant MeSH terms:
Birth Weight
Body Weight
Signs and Symptoms