Inflammatory Bowel Disease
Conditions
Keywords
Anti- TNF, inflammatory bowel disease, pregnancy, infant, immunity, Immune function
Brief summary
1. To evaluate the immune response to vaccines in infants of IBD patients treated with anti-TNF medications during pregnancy compared to infants of IBD mother not treated with anti-TNF medications. 2. To evaluate the immune function of B and T cells at 3 months and one year of age in infants of IBD patients treated with anti-TNF medications during pregnancy compared to infants of non anti-TNF treated mothers. The secondary aims are to follow anti TNF drug levels in infants born to IBD patients treated with anti-TNF medications during pregnancy and to evaluate the risk of infections during the first year of life in this population, compared to children of IBD patients not treated with anti-TNF medications during pregnancy. Significance -The results of this study have the potential to change clinical practice of anti TNF treatment during pregnancy and the follow-up of infants born to these patients
Detailed description
1\. We aim to evaluate the immune response to vaccines in infants of IBD patients treated with anti-TNF medications during pregnancy compared to infants of IBD mother not treated with anti-TNF medications. 2 WE aim to evaluate the immune function of B and T cells at 3 months and one year of age in infants of IBD patients treated with anti-TNF medications during pregnancy compared to infants of non anti-TNF treated mothers. Our secondary aims are to follow anti TNF drug levels in infants born to IBD patients treated with anti-TNF medications during pregnancy and to evaluate the risk of infections during the first year of life in this population, compared to children of IBD patients not treated with anti-TNF medications during pregnancy. The results of this study have the potential to change clinical practice of anti TNF treatment during pregnancy and the follow-up of infants born to these patients
Interventions
None listed
Sponsors
Schneider Children's Hospital
Tel Aviv Medical Center
Shaare Zedek Medical Center
Assaf-Harofeh Medical Center
Rambam Health Care Campus
Sheba Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 3 Months
Healthy volunteers
No
Inclusion criteria
1. Children born to mothers with IBD who were treated with ant-TNF medications, other medications or not medically treated for IBD during pregnancy . 2. Regular vaccination for hepatitis B at birth, 1 and 6 months of age and other scheduled non-live vaccines at 2,4, and 6 months of age. 3. Inform consent signed by the parents.
Exclusion criteria
1. Children with intrauterine or perinatal infections, congenital diseases or malformations. 2. Absence of immunization records. 3. Known immune deficiency of mother and/or child. 4. Mothers with hepatitis B
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Antibodies to vaccine agents at age 12 months. 2. Immunoglobulin levels, B and T cell production (IgG subclasses, T cell subpopulation numbers) and function (response to mitogens and antigens) at age 3 months and 1 year | 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anti TNF drug level in cord blood | birth | — |
| Infection number and type during the first year of life | 12 months | — |
| Antibiotic use in the first year | 12 months | — |
| Breast feeding influence (with and without additional medications) on the immune function of the children | 12 months | Not performed |
Countries
Israel
Outcome results
None listed