Immune Function in Offsprings of Females With Inflammatory Bowel Disease (IBD) Treated With Anti-TNF Medications During Pregnancy

Study Overview
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Brief Summary
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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. 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

Official Title
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Immune Function in Offsprings of Females With Inflammatory Bowel Disease (IBD) Treated With Anti-TNF Medications During Pregnancy

Conditions
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Inflammatory Bowel Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children born to mothers with IBD who were treated with ant-TNF medications, other medications or not medically treated for IBD during pregnancy . 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. Inform consent signed by the parents. Exclusion Criteria: Children with intrauterine or perinatal infections, congenital diseases or malformations. Absence of immunization records. Known immune deficiency of mother and/or child. 4. Mothers with hepatitis B

Ages Eligible for Study
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Maximum Age: 3 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Infants, IBD mothers, anti TNF, pregnancy<br>Infants born to mother with IBD receiving ant- TNF medications during pregnancy | |
| infants, IBD mothers, pregnancy, medications<br>Infants born to mothers with IBD receiving non anti TNF medications during pregnancy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anti- TNF, inflammatory bowel disease, pregnancy, infant, immunity, Immune function