Effect of Birth on Immunological Parameters in Cord Blood

Immunologic Activity Alteration Clinical Trial

Official title:

To Investigate the Immediate Effect of Birth on Immunological Parameters in Cord Blood, and Compare With Data of CS Born Infants Collected in the JULIUS SN Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03134768
• Other study ID #: CAE.1C.D.10
• Status: Completed
• Start date: May 2, 2016
• Est. completion date: October 12, 2017

Study information

• Verified date: April 2020
• Source: Danone Asia Pacific Holdings Pte, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of the study is to understand the immediate effect of birth on immunological parameters in vaginally born cord blood.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 12, 2017
• Est. primary completion date: November 16, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Immunologic Activity Alteration

Intervention

Other:
• This is not an interventional study
This is an observational study

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Danone Asia Pacific Holdings Pte, Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
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	1 year
Primary	Cord Blood Immunoglobulin Levels	Immunoglobulin levels will be measured in cord blood plasma	1 year
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.	1 year