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The purpose of the study is to understand the immediate effect of birth on immunological parameters in vaginally born cord blood.
The main purpose of the study is to understand the immediate effect of birth on immunological parameters in vaginally born cord blood and also whether mode and duration of delivery has an influence on immune parameters in cord blood.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| This is not an interventional study | Other | This is an observational study |
| Measure | Description | Time Frame |
|---|---|---|
| Cytokines Profile in Cord Blood Plasma | Following cytokines will be part of the profile: IL-6, IL-1, IL-2, IL-4, IL-5, IL-7, IL-8, IL-10, IL12p70, IL-13, IL-17, G-CSF, GM-CSF, IFNg, MCP-1(MCAF), MIP-1b, TNFa | 1 year |
| Cord Blood Immunoglobulin Levels | Immunoglobulin levels will be measured in cord blood plasma | 1 year |
| Allergen Stimulated Cytokine Expression in the Supernatants of Cord Blood Mononuclear Cells (CBMC) | Cellular response to allergen stimulation will be measured in supernatants of cultured cord blood mononuclear cells. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
Use of non-steroidal anti-inflammatory drugs (NSAIDs) 2 weeks prior to birth
Pregnant mothers
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Pregnant mothers undergoing normal vaginal delivery
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| Name | Affiliation | Role |
|---|---|---|
| Elena Sandalova, PhD | Danone Asia Pacific Holdings Ltd | Study Chair |
| Anne Goh, MD | KK Hospital | Study Chair |
| Mei Chin Chua, MD | KK Hospital | Principal Investigator |
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Recruitment took place in KK Women's and Children's Hospital
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| ID | Title | Description |
|---|---|---|
| FG000 | Vaginally Born Children | Cord blood samples collected from vaginally born children |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Vaginally Born Children | Cord blood samples collected from vaginally born children |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cytokines Profile in Cord Blood Plasma | Following cytokines will be part of the profile: IL-6, IL-1, IL-2, IL-4, IL-5, IL-7, IL-8, IL-10, IL12p70, IL-13, IL-17, G-CSF, GM-CSF, IFNg, MCP-1(MCAF), MIP-1b, TNFa | Other cytokines were out of detection limits. | Posted | Mean | Standard Deviation | pg/ml | 1 year |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vaginally Born Children | Cord blood samples collected from vaginally born children |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Elena Sandalova | Danone Nutricia Research | 6568309433 | elena.sandalova@danone.com |
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cord blood
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Primary | Cord Blood Immunoglobulin Levels | Immunoglobulin levels will be measured in cord blood plasma | Posted | Mean | Standard Deviation | pg/ml | 1 year |
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| Primary | Allergen Stimulated Cytokine Expression in the Supernatants of Cord Blood Mononuclear Cells (CBMC) | Cellular response to allergen stimulation will be measured in supernatants of cultured cord blood mononuclear cells. | IL-6 was measured after incubation with House Dust mite extracts. The mean expression of IL-6 by the cord blood mononuclear cells in response to house dust mite extract is presented here. | Posted | Mean | Standard Deviation | pg/ml | 1 year |
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| 0 |
| 50 |
| 0 |
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| 0 |
| 50 |
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