Human Milk Fortifier and Cytokine Profile
| Tracking Information | |||||||||
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| First Received Date ICMJE | January 15, 2008 | ||||||||
| Last Updated Date | July 23, 2008 | ||||||||
| Start Date ICMJE | November 2007 | ||||||||
| Primary Completion Date | June 2008 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Cytokine profile pre and post initiation of HMF [ Time Frame: up to 14 days ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00601081 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Human Milk Fortifier and Cytokine Profile | ||||||||
| Official Title ICMJE | 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 Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description: Blood and stool |
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| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Infants hospitalized in the newborn intensive care unit. |
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| Condition ICMJE | Infant, Very Low Birth Weight | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | 1
Very low birth weight and preterm infants who will likely receive fortification of breast milk with HMF |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 24 | ||||||||
| Completion Date | June 2008 | ||||||||
| Primary Completion Date | June 2008 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | up to 6 Months | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00601081 | ||||||||
| Other Study ID Numbers ICMJE | 27127 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Christopher Hsu, MD, Christiana Hospital | ||||||||
| Study Sponsor ICMJE | Christiana Care Health Services | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Christiana Care Health Services | ||||||||
| Verification Date | July 2008 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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