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| Tracking Information | |||||||||
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| First Received Date † | January 15, 2008 | ||||||||
| Last Updated Date | July 23, 2008 | ||||||||
| Start Date † | November 2007 | ||||||||
| Current Primary Outcome Measures † |
Cytokine profile pre and post initiation of HMF [ Time Frame: up to 14 days ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures † | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00601081 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures † | |||||||||
| Original Secondary Outcome Measures † | |||||||||
| Descriptive Information | |||||||||
| Brief Title † | Human Milk Fortifier and Cytokine Profile | ||||||||
| Official Title † | Alterations in the Cytokine Profile of Premature Infants After Human Milk Fortifier | ||||||||
| 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. |
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| 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. |
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| Study Phase | |||||||||
| Study Type † | Observational | ||||||||
| Study Design † | Cohort, Prospective | ||||||||
| Condition † | Infant, Very Low Birth Weight | ||||||||
| Intervention † | |||||||||
| Study Arms / Comparison Groups | Very low birth weight and preterm infants who will likely receive fortification of breast milk with HMF | ||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status † | Completed | ||||||||
| Enrollment † | 24 | ||||||||
| Completion Date | June 2008 | ||||||||
| Primary Completion Date | June 2008 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | up to 6 Months | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts †† | |||||||||
| Location Countries † | United States | ||||||||
| Expanded Access Status | |||||||||
| Administrative Information | |||||||||
| NCT ID † | NCT00601081 | ||||||||
| Responsible Party | Christopher Hsu, MD, Christiana Hospital | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | Christiana Care Health Services | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | Christiana Care Health Services | ||||||||
| Verification Date | July 2008 | ||||||||
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† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |
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