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Study on the Safety for the Newborn of the Use of Biologics During Pregnancy by Mothers Affected by Autoimmune Diseases
Sponsor: IRCCS San Raffaele
Summary
The goal of the study is to evaluate the effects on the offspring and therefore the safety of using biologic agents during pregnancy and their eventual consequences on children. The effects considered are divided into peri-partum and more long-term effects. Demonstration of safety in children born from mothers who received biologics during pregnancy will pave the way of their use in other women affected by autoimmune diseases unresponsive to standard treatment.
Official title: Study on the Safety for the Newborn of the Use of Biologics During Pregnancy
Key Details
Gender
All
Age Range
1 Day - 12 Years
Study Type
OBSERVATIONAL
Enrollment
50
Start Date
2018-08-31
Completion Date
2026-08-31
Last Updated
2019-12-13
Healthy Volunteers
Not specified
Interventions
clinical evaluation
\- In children: general clinical evaluation, birth weight, APGAR, ECG, admission to ICU, hospital admissions in perinatal age, presence of malformations; complete blood count, inflammatory index, complement, antibiotic treatment, brain ultra-sound, presence of infection, presence of sepsis, presence of necrotizing enterocolitis, growth curve, presence of recurrent infections, developmental milestones, response to vaccines, admission to hospital in the first year of life.
Locations (1)
IRCCS ospedale san raffaele
Milan, Lombardy, Italy