Effect of Birth on Immunological Parameters in Cord Blood

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

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

Study Overview

• Status: Completed
• Conditions: Immunologic Activity Alteration
• Intervention / Treatment: Other: This is not an interventional study

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.

• Study Type: Observational
• Enrollment (Actual): 50

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Pregnant mothers undergoing normal vaginal delivery

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Danone Asia Pacific Holdings Pte, Ltd.
• Investigators: Study Chair: Elena Sandalova, PhD, Danone Asia Pacific Holdings Ltd; Study Chair: Anne Goh, MD, KK Hospital; Principal Investigator: Mei Chin Chua, MD, KK Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2016
• Primary Completion (Actual): November 16, 2016
• Study Completion (Actual): October 12, 2017

Study Registration Dates

• First Submitted: April 26, 2017
• First Submitted That Met QC Criteria: April 26, 2017
• First Posted (Actual): May 1, 2017

Study Record Updates

• Last Update Posted (Actual): April 3, 2020
• Last Update Submitted That Met QC Criteria: April 1, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: CAE.1C.D.10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No