Assessing the risk of infection among babies born to mothers with Systemic Lupus Erythematosus; a study of the first two years of life.

Study type
Protocol
Date of Approval
Study reference ID
16_243
Lay Summary

Systemic Lupus Erythematosus is a clinically heterogeneous autoimmune disease which predisposes women to higher risk of infection. Based on US data, 3,400 women with lupus are admitted to the hospital each year for childbirth and many deliver seemingly healthy babies. The maternal changes that occur during pregnancy are substantial and biologic observations suggest that Systemic Lupus Erythematosus may influence the development of the fetus. Systemic Lupus Erythematosus during pregnancy has been associated with childhood dyslexia; maternal cells have been detected with higher frequency in cardiac specimens of patients with neonatal lupus syndrome; and immunosuppressants, such as those used to treat SLE, have been linked to a reduced effect of the tetanus vaccine in children. Thus, studies have shown interaction between the mother and fetal development. We postulate that a mother with Systemic Lupus Erythematosus will have a child with a weaker immune system, thus, at higher risk for infection, compared to a child born to a healthy mother. We are seeking to address this question and identify the most common infections seen in children born to women with Systemic Lupus Erythematosus and identify whether these children have a higher risk of infection compared to children born to healthy mothers.

Technical Summary

This study will investigate whether children born to women with Systemic Lupus Erythematosus (SLE) have a higher risk of infection during the first two years of life than children born to healthy women. We will utilize a retrospective cohort analysis using CPRD Gold, the in-patient Hospital Episode Statistics (HES) and the HES Mother-Baby link. Four babies born to healthy women will be matched as controls by birth year (and month, if available) and maternal age at birth. A frequency table will be reported for all infections seen in the exposed population and collapsed into categories bacterial, viral, fungal and other; this will be repeated for the unexposed. Risk ratios and 95% confidence intervals will be reported. We will assess the impact of breastfeeding and preterm birth on infection in the exposed and unexposed. Risk analysis will be conducted for maternal SLE organ involvement, the Systemic Lupus Activity Measure (SLAM) index and medication use during pregnancy. All risk ratios will be calculated for three time periods in the child's life: the neonatal period (birth-28 days), 29 days - 6 months and >6 months to 2 years of life to identify if any relationship persists into early childhood.

Health Outcomes to be Measured

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Collaborators

Denise Elsasser Dietz - Chief Investigator - Rutgers, The State University of New Jersey
Denise Elsasser Dietz - Corresponding Applicant - Rutgers, The State University of New Jersey
Anne Dilley - Collaborator - Biogen
Demissie Kitaw - Collaborator - Rutgers, The State University of New Jersey
Jeffery (Jeff) Allen - Collaborator - Biogen
Lin Young - Collaborator - Rutgers, The State University of New Jersey
Stephan Schwander - Collaborator - Rutgers, The State University of New Jersey
Susan Eaton - Collaborator - Biogen
Teresa Janevic - Collaborator - Icahn School of Medicine at Mount Sinai
Todd Rosen - Collaborator - Rutgers, The State University of New Jersey

Linkages

HES Admitted Patient Care