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Completed

NCT Number: NCT00601081

Human Milk Fortifier and Cytokine Profile

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

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Key information

Conditions

Infant, Very Low Birth Weight

Age range

Up to 6 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Christiana Hospital

Newark, Delaware, 19718, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Cytokine profile pre and post initiation of HMF

    Time frame: up to 14 days

Sponsors and collaborators

Lead sponsor

Christiana Care Health Services

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jan 25, 2008
Registry last updated
May 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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