The Research Registry for Neonatal Lupus
Women with lupus and other related disorders produce certain antibodies in the blood. Some women have these antibodies even if they have not yet developed symptoms of lupus or Sjogren's syndrome. When these women become pregnant, they may pass the antibodies to their infants. The infants may then develop a disease called neonatal lupus. The symptoms of neonatal lupus include an abnormally slow heart beat (heart block) and a skin rash. This registry collects information on women and infants affected by neonatal lupus as well as other family members who may be healthy.
Systemic Lupus Erythematosus
Congenital Heart Block
Other: No intervention; observational
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||The Research Registry for Neonatal Lupus|
- means of curing and/or preventing neonatal lupus [ Time Frame: ongoing ] [ Designated as safety issue: No ]means of curing and/or preventing neonatal lupus
- identification of pathogenesis of neonatal lupus [ Time Frame: ongoing ] [ Designated as safety issue: No ]identification of pathogenesis of neonatal lupus
Biospecimen Retention: Samples With DNA
|Study Start Date:||September 1994|
|Estimated Study Completion Date:||January 2020|
|Estimated Primary Completion Date:||January 2020 (Final data collection date for primary outcome measure)|
human beings of all sexes, ages, and health statuses
Other: No intervention; observational
Other Name: The study is observational
Neonatal lupus is a disease seen in babies born to mothers who have antibodies to SSA/Ro and/or SSB/La proteins. The mother may have systemic lupus erythematosus, Sjogren's syndrome, or be otherwise healthy. Heart block and a characteristic skin rash are the primary manifestations of neonatal lupus.
The Research Registry for Neonatal Lupus was initiated in 1994 to help basic scientists and clinicians better understand the cause of neonatal lupus and discover a cure. The Research Registry is a central repository of patient information, sera, and DNA. The Registry provides blood samples (kept anonymous) to scientists studying neonatal lupus. Information from the registry forms the basis of family counseling and tracks important data such as recurrence rates in subsequent pregnancies and the effects of treatments. The Research Registry also serves as an educational resource for women who are eager to learn about this disease.
Women with a child affected by neonatal lupus may enroll in the Registry. Women can be self referred or referred by their doctors. Siblings of women with a child affected by neonatal lupus, fathers and maternal grandparents of children with neonatal lupus, and unaffected siblings of a child with neonatal lupus are also invited to participate in this study. All information on the mother and her family is confidential; only nonidentifying information will be provided to researchers. Women interested in the registry will be sent articles and educational materials about neonatal lupus, a consent form for the Registry, and an enrollment questionnaire. Participants will be asked to sign a medical records release form. Participants will also be asked to donate a blood sample for antibody testing and DNA isolation.
|Contact: Zoey Smithemail@example.com|
|Contact: Jill Buyon, M.D.||firstname.lastname@example.org|
|United States, New York|
|Jill P. Buyon, MD||Recruiting|
|New York, New York, United States, 10016|
|Contact: Zoey Smith 212-263-0743 email@example.com|
|Contact: Jill Buyon, M.D. 212-263-0746 firstname.lastname@example.org|
|Principal Investigator: Jill P. Buyon, MD|
|Study Director:||Jill P. Buyon, MD||NYU Medical Center, NYU School of Medicine|