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NCT02079441 Clinical Trial

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

Inflammatory Bowel Disease Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02079441
Other study ID # SHEBA-13-0613-BW-CTIL
Secondary ID
Status Not yet recruiting
Phase N/A
First received February 27, 2014
Last updated March 4, 2014
Start date March 2014

Study information
Verified date March 2014
Source Sheba Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 50
Est. completion date
Est. primary completion date February 2017
Accepts healthy volunteers No
Gender Both
Age group N/A to 3 Months
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (6)
Lead Sponsor Collaborator
Sheba Medical Center Assaf-Harofeh Medical Center, Rambam Health Care Campus, Schneider Children's Hospital, Shaare Zedek Medical Center, Tel Aviv Medical Center

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Anti TNF drug level in cord blood birth No
Secondary Infection number and type during the first year of life 12 months No
Secondary Antibiotic use in the first year 12 months No
Secondary Breast feeding influence (with and without additional medications) on the immune function of the children 12 months No
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