Human Milk Fortifier and Cytokine Profile

NCT ID: NCT00601081

Last Updated: 2017-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-11-30

Study Completion Date

2008-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Infant, Very Low Birth Weight

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

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

No interventions assigned to this group

Eligibility Criteria

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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
Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Christiana Care Health Services

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert G. Locke, DO

Role: PRINCIPAL_INVESTIGATOR

Christiana Hospital

Christopher T. Hsu, MD

Role: PRINCIPAL_INVESTIGATOR

Christiana Hospital

Locations

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Christiana Hospital

Newark, Delaware, United States

Site Status

Countries

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United States

Other Identifiers

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27127

Identifier Type: -

Identifier Source: org_study_id

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