Human Milk Fortifier and Cytokine Profile

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00601081

Enrollment

Registered

2008-01-25

Start date

2007-11-30

Completion date

2008-06-30

Last updated

2017-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infant, Very Low Birth Weight

Keywords

Very low birth weight infants, HMF, immune system function

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 6 Months

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

Design outcomes

Primary

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

Countries

United States

Outcome results