Trial Outcomes & Findings for Effect of Birth on Immunological Parameters in Cord Blood (NCT NCT03134768)

NCT ID: NCT03134768

Last Updated: 2020-04-03

Results Overview

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

• Recruitment status: COMPLETED
• Target enrollment: 50 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2020-04-03

Participant Flow

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

Participant milestones

Measure	Vaginally Born Children Cord blood samples collected from vaginally born children
Overall Study STARTED	50
Overall Study COMPLETED	50
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Birth on Immunological Parameters in Cord Blood

Baseline characteristics by cohort

Measure	Vaginally Born Children n=50 Participants Cord blood samples collected from vaginally born children
Age, Continuous	0 years n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: Other cytokines were out of detection limits.

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

Outcome measures

Measure	Vaginally Born Children n=50 Participants Cord blood samples collected from vaginally born children
Cytokines Profile in Cord Blood Plasma IL-6	1.6 pg/ml Standard Deviation 7.1
Cytokines Profile in Cord Blood Plasma TNFa	21.81 pg/ml Standard Deviation 8.4
Cytokines Profile in Cord Blood Plasma IL-8	165 pg/ml Standard Deviation 279
Cytokines Profile in Cord Blood Plasma G-SCF	14 pg/ml Standard Deviation 44

PRIMARY outcome

Timeframe: 1 year

Immunoglobulin levels will be measured in cord blood plasma

Outcome measures

Measure	Vaginally Born Children n=50 Participants Cord blood samples collected from vaginally born children
Cord Blood Immunoglobulin Levels IgE	1.7 pg/ml Standard Deviation 2
Cord Blood Immunoglobulin Levels IgG	2613064 pg/ml Standard Deviation 3066008

PRIMARY outcome

Timeframe: 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.

Cellular response to allergen stimulation will be measured in supernatants of cultured cord blood mononuclear cells.

Outcome measures

Measure	Vaginally Born Children n=50 Participants Cord blood samples collected from vaginally born children
Allergen Stimulated Cytokine Expression in the Supernatants of Cord Blood Mononuclear Cells (CBMC)	18612 pg/ml Standard Deviation 38892

Adverse Events

Vaginally Born Children

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Elena Sandalova

Danone Nutricia Research

Phone: 6568309433

Email: elena.sandalova@danone.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60