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Human Milk Fortifier and Cytokine Profile

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Christiana Care Health Services

Status

Completed

Conditions

Infant, Very Low Birth Weight

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Full 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.

Enrollment

24 patients

Sex

All

Ages

Under 6 months old

Volunteers

Accepts Healthy Volunteers

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

Trial design

24 participants in 1 patient group

1
Description:
Very low birth weight and preterm infants who will likely receive fortification of breast milk with HMF

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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