Text Size

Human Milk Fortifier and Cytokine Profile

This study has been completed.
Sponsor:
Information provided by:
Christiana Care Health Services
ClinicalTrials.gov Identifier:
NCT00601081
First received: January 15, 2008
Last updated: July 23, 2008
Last verified: July 2008
History of Changes
  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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Alterations in the Cytokine Profile of Premature Infants After Human Milk Fortifier

Resource links provided by NLM:

U.S. FDA Resources

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

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

No publications provided

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

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

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

ClinicalTrials.gov processed this record on May 22, 2013