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Human Milk Fortifier and Cytokine Profile

Sponsor
Christiana Care Health Services (Other)
Overall Status
Completed
CT.gov ID
NCT00601081
Collaborator
(none)
24
Enrollment
1
Location
7
Duration (Months)
3.4
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    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 Design

    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 :
    Nov 1, 2007
    Actual Primary Completion Date :
    Jun 1, 2008
    Actual Study Completion Date :
    Jun 1, 2008

    Arms and Interventions

    Arm Intervention/Treatment
    1

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

    Outcome Measures

    Primary Outcome Measures

    1. Cytokine profile pre and post initiation of HMF [up to 14 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 6 Months
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Christiana Care Health Services
    ClinicalTrials.gov Identifier:
    NCT00601081
    Other Study ID Numbers:
    • 27127
    First Posted:
    Jan 25, 2008
    Last Update Posted:
    May 10, 2017
    Last Verified:
    May 1, 2017
    Keywords provided by Christiana Care Health Services
    Very low birth weight infants
    HMF
    immune system function
    Additional relevant MeSH terms:
    Birth Weight

    Study Results

    No Results Posted as of May 10, 2017