Immunologic Activity AlterationNCT03134768
Effect of Birth on Immunological Parameters in Cord Blood
An observational study of Immunologic Activity Alteration, run by Danone Asia Pacific Holdings Pte, Ltd..
Trial summary
The purpose of the study is to understand the immediate effect of birth on immunological parameters in vaginally born cord blood. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Immunologic Activity Alteration
- What is being tested?
- This is not an interventional study
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 2 May 2016to 12 Oct 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Pregnant mothers undergoing normal vaginal delivery
Who may be able to join
- Pregnant mothers undergoing normal vaginal delivery
Who cannot join
- 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
About this study
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
The purpose of the study is to understand the immediate effect of birth on immunological parameters in vaginally born cord blood.
Read the 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.
- Conditions
- Immunologic Activity Alteration
- Being tested
- This is not an interventional study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This is not an interventional studyOther
This is an observational study
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Cord Blood Immunoglobulin Levels
Immunoglobulin levels will be measured in cord blood plasma
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2017
- Study start2 May 2016
- Primary completion16 Nov 2016
- Study completion12 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Immunologic Activity AlterationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danone Asia Pacific Holdings Pte, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elena Sandalova, PhD, Study chair, Danone Asia Pacific Holdings LtdAnne Goh, MD, Study chair, KK HospitalMei Chin Chua, MD, Principal investigator, KK Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03134768
- Sponsor's protocol ID
- CAE.1C.D.10
- Status last verified
- Apr 2020
- First submitted
- 26 Apr 2017
- Last updated
- 3 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03134768
- Acronym / sponsor ID
- CAE.1C.D.10
- Conditions
- Immunologic Activity Alteration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Danone Asia Pacific Holdings Pte, Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 May 2016 (actual)
- Primary completion
- 16 Nov 2016 (actual)
- Study completion
- 12 Oct 2017 (actual)
- First posted
- 1 May 2017 (actual)
- Results
- Posted 19 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant mothers undergoing normal vaginal delivery
Key inclusion criteria (1 listed)
- Pregnant mothers undergoing normal vaginal delivery
Key exclusion criteria (4 listed)
- Use of non-steroidal anti-inflammatory drugs (NSAIDs) 2 weeks prior to birth
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| This is not an interventional studyThis is an observational study | Other | – |
Primary outcome
Cytokines Profile in Cord Blood Plasma
Time frame: 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
Time frame: 1 year
Immunoglobulin levels will be measured in cord blood plasma
Allergen Stimulated Cytokine Expression in the Supernatants of Cord Blood Mononuclear Cells (CBMC)
Time frame: 1 year
Cellular response to allergen stimulation will be measured in supernatants of cultured cord blood mononuclear cells.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Atopic Dermatitis, Atopic Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elena Sandalova, PhD study chair
Danone Asia Pacific Holdings Ltd
Anne Goh, MD study chair
KK Hospital
Mei Chin Chua, MD principal investigator
KK Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Immunologic Activity Alteration, run by Danone Asia Pacific Holdings Pte, Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cytokines Profile in Cord Blood Plasma (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2020; AzTrials last refreshed its copy on 6 Nov 2026.