Predictors of Cord Blood Immunoglobin E (IgE) Levels
Recruitment status was Recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | May 13, 2009 | ||||
| Last Updated Date | May 13, 2009 | ||||
| Start Date ICMJE | April 2009 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
cord blood IgE [ Time Frame: at birth ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
Cord blood cytokines or other mediators [ Time Frame: at birth ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Predictors of Cord Blood Immunoglobin E (IgE) Levels | ||||
| Official Title ICMJE | Not Provided | ||||
| Brief Summary | Background: Increased total serum IgE levels are a common characteristic of atopic diseases. Increased cord blood IgE levels, in conjunction with a family history of atopy, are associated with the development of allergic diseases in children. However, little is known about predictors of cord blood IgE levels. Objective: The aim of our study was to identify predictors of cord blood IgE levels in an ongoing large birth cohort of infants with or without a family history of atopy. Methods: Blood sampling of mothers was performed just before the delivery of newborns. Cord blood was also collected when the child was born. Maternal and cord blood was measured for IgE levels and cytokines. Questionnaires were administered after birth of the infant. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | hospital and primary care clinic based study |
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| Condition ICMJE | Atopy | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Prenatal factors
Prenatal factors to predict cord blood IgE |
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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 | Recruiting | ||||
| Estimated Enrollment ICMJE | 800 | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Taiwan | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00902096 | ||||
| Other Study ID Numbers ICMJE | 2009008 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Chien-Han Chen, Min-Sheng General Hospital | ||||
| Study Sponsor ICMJE | Min-Sheng General Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Min-Sheng General Hospital | ||||
| Verification Date | May 2009 | ||||
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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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