N/A
N=50
Effect of Birth on Immunological Parameters in Cord Blood
Immunologic Activity Alteration
Bottom Line
View on ClinicalTrials.gov: NCT03134768 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcome: Primary: Cytokines Profile in Cord Blood Plasma — 1.6; 21.81; 165; 14 pg/ml
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- This is not an interventional study (Other)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- Danone Asia Pacific Holdings Pte, Ltd.
- Primary completion
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cytokines Profile in Cord Blood Plasma |
1.6; 21.81; 165; 14 | — |
| PRIMARY Cord Blood Immunoglobulin Levels |
1.7; 2613064 | — |
| PRIMARY Allergen Stimulated Cytokine Expression in the Supernatants of Cord Blood Mononuclear Cells (CBMC) |
18612 | — |
Summary
The purpose of the study is to understand the immediate effect of birth on immunological parameters in vaginally born cord blood.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03134768). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.