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Long term health outcome of children exposed to IBD medication during pregnancy


- candidate number21094
- NTR NumberNTR4985
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-dec-2014
- Secondary IDsS.L. Kanis Erasmus Medical Center
- Public TitleLong term health outcome of children exposed to IBD medication during pregnancy
- Scientific TitleLong-term effects of the intrauterine exposure to infliximab on the health of children born to mothers with inflammatory bowel disease (IBD)
- ACRONYMThe SHOP initiative: The Study on (long term) Health Outcomes in Progeny of IBD mothers.
- hypothesis
- Healt Condition(s) or Problem(s) studiedChildren, Health
- Inclusion criteriaWomen with IBD that gave birth between 1999 and 2011 after the diagnosis of IBD.
- Exclusion criteriaIncapacity to understand the informed consent
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 5-mrt-2010
- planned closingdate1-jan-2016
- Target number of participants1000
- InterventionsQuestionnaire and consent both parents to contact GP for child information
- Primary outcome- Growth
- Infections in first 5 years of life for which antibiotics were needed
- Allergies
- Allergic reactions to vaccinations
- Chronic diseases
- Secondary outcomeNo
- TimepointsInclusion between 2013-2015
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES S.L. Kanis
- CONTACT for SCIENTIFIC QUERIES S.L. Kanis
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD1-dec-2014 - 15-aug-2015


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