Study of the Development of Human Immune System of Newborns by Antigen Chips
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ClinicalTrials.gov Identifier: NCT00843648 |
Recruitment Status : Unknown
Verified February 2009 by Sheba Medical Center.
Recruitment status was: Not yet recruiting
First Posted : February 13, 2009
Last Update Posted : February 13, 2009
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The immune system is a dynamic, constantly evolving network. Excluding autoimmune diseases, healthy individuals are also known to have a large number of circulating antibodies that can recognize proteins of their own tissues. These antibodies are known as natural antibodies and previous studies suggested that some features of these "self" components are shared by individuals in certain physiological states. Thus, monitoring self immunoglobulins can provide an overview of the various states of the immune system. To do so, and in the process to obtain systems biology view of the immune system, the newly developed Antigen Chip technology has been used.
To further investigate this subject we plan to carry out broader investigations that will be conducted in collaboration with the group of Prof. Eshel Ben-Jacob from the university of Tel-Aviv and Prof. Irun Cohen from the Weizmann Institute that have the required experimental and analytical expertise and facilities. The studies will include follow-up on the immune state of babies and their mothers for several months post birth using the Antigen Chip and analyzed by the Immune holography method. The investigations will also include comparative studies between the immune signature of different body fluids, the effects of feeding, and the effect method and time of labor.
Condition or disease |
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Antibody Immune Profile |
Study Type : | Observational |
Estimated Enrollment : | 100 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Study Start Date : | March 2009 |
Estimated Primary Completion Date : | March 2010 |
Estimated Study Completion Date : | March 2011 |
Group/Cohort |
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preterms
mother and preterm babies
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term-bfing
term breastfed babies and mothers
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term-PIF
term non breastfed babies and mothers
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c-section
c-section babies and their mothers
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Ages Eligible for Study: | up to 7 Weeks (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- Term and preterm newborns and their mothers
- Age 1 day to 7 weeks
Exclusion Criteria:
- Maternal immune dieases
- Major congential malformations

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00843648
Israel | |
Sheba Medical Center | |
Ramat Gan, Israel, 52621 | |
Contact: Ayala Maayan, MD 972-3-5302227 maayan@post.tau.ac.il |
Responsible Party: | Dr. Ayala Maayan, Sheba Medical Center |
ClinicalTrials.gov Identifier: | NCT00843648 |
Other Study ID Numbers: |
SHEBA-08-5441-AM-CTIL |
First Posted: | February 13, 2009 Key Record Dates |
Last Update Posted: | February 13, 2009 |
Last Verified: | February 2009 |
antibody immune profile preterm c-section breastfeeding |