Human Milk Fortifier and Cytokine Profile

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

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

Study Overview

• Status: Completed
• Conditions: 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
• Enrollment (Actual): 24

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 6 months (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Infants hospitalized in the newborn intensive care unit.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
1; Very low birth weight and preterm infants who will likely receive fortification of breast milk with HMF

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cytokine profile pre and post initiation of HMF	up to 14 days

Collaborators and Investigators

• Sponsor: Christiana Care Health Services
• Investigators: Principal Investigator: Robert G. Locke, DO, Christiana Hospital; Principal Investigator: Christopher T. Hsu, MD, Christiana Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Actual): June 1, 2008
• Study Completion (Actual): June 1, 2008

Study Registration Dates

• First Submitted: January 15, 2008
• First Submitted That Met QC Criteria: January 15, 2008
• First Posted (Estimate): January 25, 2008

Study Record Updates

• Last Update Posted (Actual): May 10, 2017
• Last Update Submitted That Met QC Criteria: May 9, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Very low birth weight infants; HMF; immune system function
• Additional Relevant MeSH Terms: Body Weight; Birth Weight
• Other Study ID Numbers: 27127