Immunologic Activity Alteration
Conditions
Brief summary
The purpose of the study is to understand the immediate effect of birth on immunological parameters in vaginally born cord blood.
Detailed description
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.
Interventions
This is an observational study
Sponsors
Danone Asia Pacific Holdings Pte, Ltd.
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion criteria
* Pregnant mothers undergoing normal vaginal delivery
Exclusion criteria
* Use of non-steroidal anti-inflammatory drugs (NSAIDs) 2 weeks prior to birth * Antenatal antibiotics treatment (2 weeks prior to birth) * Diabetes mellitus requiring insulin treatment during pregnancy * Uncontrollable Hyperthyroidism during pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cytokines Profile in Cord Blood Plasma | 1 year | 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 |
| Cord Blood Immunoglobulin Levels | 1 year | Immunoglobulin levels will be measured in cord blood plasma |
| Allergen Stimulated Cytokine Expression in the Supernatants of Cord Blood Mononuclear Cells (CBMC) | 1 year | Cellular response to allergen stimulation will be measured in supernatants of cultured cord blood mononuclear cells. |
Participant flow
Recruitment details
Recruitment took place in KK Women's and Children's Hospital
Participants by arm
| Arm | Count |
|---|---|
| Vaginally Born Children Cord blood samples collected from vaginally born children | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | Vaginally Born Children |
|---|---|
| Age, Continuous | 0 years |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 50 |
| other Total, other adverse events | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 |
Outcome results
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.
Time frame: 1 year
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vaginally Born Children | Allergen Stimulated Cytokine Expression in the Supernatants of Cord Blood Mononuclear Cells (CBMC) | 18612 pg/ml | Standard Deviation 38892 |
Primary
Cord Blood Immunoglobulin Levels
Immunoglobulin levels will be measured in cord blood plasma
Time frame: 1 year
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vaginally Born Children | Cord Blood Immunoglobulin Levels | IgE | 1.7 pg/ml | Standard Deviation 2 |
| Vaginally Born Children | Cord Blood Immunoglobulin Levels | IgG | 2613064 pg/ml | Standard Deviation 3066008 |
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
Time frame: 1 year
Population: Other cytokines were out of detection limits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vaginally Born Children | Cytokines Profile in Cord Blood Plasma | IL-6 | 1.6 pg/ml | Standard Deviation 7.1 |
| Vaginally Born Children | Cytokines Profile in Cord Blood Plasma | TNFa | 21.81 pg/ml | Standard Deviation 8.4 |
| Vaginally Born Children | Cytokines Profile in Cord Blood Plasma | IL-8 | 165 pg/ml | Standard Deviation 279 |
| Vaginally Born Children | Cytokines Profile in Cord Blood Plasma | G-SCF | 14 pg/ml | Standard Deviation 44 |