Effect of Birth on Immunological Parameters in Cord Blood

• Sponsor: Danone Asia Pacific Holdings Pte, Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03134768
• Collaborator: (none)
• Enrollment: 50
• Actual Duration (Months): 17.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Immunologic Activity Alteration	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 Design

• Study Type: Observational
• Actual Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• 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
• Actual Study Start Date: May 2, 2016
• Actual Primary Completion Date: Nov 16, 2016
• Actual Study Completion Date: Oct 12, 2017

Outcome Measures

Primary Outcome Measures

1. 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

2. Cord Blood Immunoglobulin Levels [1 year]

   Immunoglobulin levels will be measured in cord blood plasma

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Danone Asia Pacific Holdings Pte, Ltd.
• ClinicalTrials.gov Identifier: NCT03134768
• Other Study ID Numbers: CAE.1C.D.10
• First Posted: May 1, 2017
• Last Update Posted: Apr 3, 2020
• Last Verified: Apr 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

Participant Flow

Recruitment Details	Recruitment took place in KK Women's and Children's Hospital

Arm/Group Title	Vaginally Born Children
Arm/Group Description	Cord blood samples collected from vaginally born children
Period Title: Overall Study
STARTED	50
COMPLETED	50
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Vaginally Born Children
Arm/Group Description	Cord blood samples collected from vaginally born children
Overall Participants	50
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	0
Sex: Female, Male (Count of Participants)
Female	23 46%
Male	27 54%

Outcome Measures

1. Primary Outcome

Title	Cytokines Profile in Cord Blood Plasma
Description	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

Outcome Measure Data

Analysis Population Description

Other cytokines were out of detection limits.

Arm/Group Title	Vaginally Born Children
Arm/Group Description	Cord blood samples collected from vaginally born children
Measure Participants	50
IL-6	1.6 (7.1)
TNFa	21.81 (8.4)
IL-8	165 (279)
G-SCF	14 (44)

2. Primary Outcome

Title	Cord Blood Immunoglobulin Levels
Description	Immunoglobulin levels will be measured in cord blood plasma
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Vaginally Born Children
Arm/Group Description	Cord blood samples collected from vaginally born children
Measure Participants	50
IgE	1.7 (2)
IgG	2613064 (3066008)

3. Primary Outcome

Title	Allergen Stimulated Cytokine Expression in the Supernatants of Cord Blood Mononuclear Cells (CBMC)
Description	Cellular response to allergen stimulation will be measured in supernatants of cultured cord blood mononuclear cells.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

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/Group Title	Vaginally Born Children
Arm/Group Description	Cord blood samples collected from vaginally born children
Measure Participants	50
Mean (Standard Deviation) [pg/ml]	18612 (38892)

Adverse Events

Arm/Group Title	Vaginally Born Children
Arm/Group Description	Cord blood samples collected from vaginally born children
All Cause Mortality
	Vaginally Born Children
	Affected / at Risk (%)	# Events
Total	0/50 (0%)
Serious Adverse Events
	Vaginally Born Children
	Affected / at Risk (%)	# Events
Total	0/50 (0%)
Other (Not Including Serious) Adverse Events
	Vaginally Born Children
	Affected / at Risk (%)	# Events
Total	0/50 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.