Study on the Safety for the Newborn of the Use of Biologics During Pregnancy by Mothers Affected by Autoimmune Diseases

NCT04197232 | Recruiting DMC

• 1 other identifier: BIOGN1
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Suspected Damage to Fetus From Biologic Agents

Outcome Measures

Primary Outcomes (6)

• Safety on fetus of biologic agents used during pregnancy

  Evaluation of increased incidence of preterm births (measured by gestational age at birth (gestational weeks)

  8 years

• Safety on fetus of biologic agents used during pregnancy - fetal development

  Evaluation of normal intrauterine development (measured by presence of Intra-Uterine Growth Restriction, presence of malformations (number#), birth weight (grams), length (cm), head circumference (cm))

  8 years

• Safety on fetus of biologic agents used during pregnancy - adequate growth for GA

  Evaluation of normal intrauterine development - birth weight (grams), length (cm), head circumference (cm))

  8 years

• Safety on fetus of biologic agents used during pregnancy - perinatal complications

  Evaluation of increased rate of perinatal complications (measured by: admission to ICU (number#), hospital admissions in perinatal) (number#)

  8 years

• Safety on fetus of biologic agents used during pregnancy - neurological development

  Evaluation of developmental milestones (age in months of acquisition of head control, sitting position, crawling and standing position)

  8 years

• Safety on fetus of biologic agents used during pregnancy - immunological evaluation

  Evaluation of immunological status (complete blood count (absolute counts od WBC, Lymphocytes and Neutrophilis), presence of infection (number #), response to vaccines (presence/absence)

  8 years

Study Arms (2)

exposed

The modality of study is a cohort study that evaluates the performance of children exposed to biologic agents during pregnancy compared to the performance of children born at the same gestational age not exposed to biologic agents.

not exposed

The modality of study is a cohort study that evaluates the performance of children exposed to biologic agents during pregnancy compared to the performance of children born at the same gestational age not exposed to biologic agents.

Other: clinical evaluation

Interventions

clinical evaluation OTHER

\- 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.

not exposed

Eligibility Criteria

• Age: 1 Day - 12 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

children born from mothers treated with biologic agents during pregnancy

You may qualify if:

• children born from mothers treated with biologic agents

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

IRCCS ospedale san raffaele

Milan, Lombardy, 20132, Italy

RECRUITING

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 27, 2019
• First Posted: December 13, 2019
• Study Start: August 31, 2018
• Primary Completion: August 31, 2018
• Study Completion (Estimated): August 31, 2026
• Last Updated: December 13, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)