The Research Registry for Neonatal Lupus

Brief Title

The Research Registry for Neonatal Lupus

Official Title

The Research Registry for Neonatal Lupus

Brief Summary

      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.

Detailed Description

      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

Study Type


Primary Outcome

means of curing and/or preventing neonatal lupus

Secondary Outcome

 identification of pathogenesis of neonatal lupus


Neonatal Lupus


No intervention; observational

Study Arms / Comparison Groups

 human beings
Description:  human beings of all sexes, ages, and health statuses


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

September 1994

Completion Date

January 2025

Primary Completion Date

June 2016

Eligibility Criteria

        Inclusion Criteria:

          -  Mother with antibodies to SSA/Ro, SSB/La, or ribonucleoproteins (RNP) OR Child of
             mother with such antibodies who has neonatal lupus (congenital heart block, transient
             skin rash, and/or hepatic or hematologic manifestations) OR Father of neonatal
             lupus-affected child OR Maternal grandparents of neonatal lupus-affected child OR
             Maternal aunts and uncles of neonatal lupus-affected OR Unaffected siblings of
             neonatal lupus-affected child




N/A - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers


Jill P. Buyon, MD, 212-263-0743, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations



Organization ID


Responsible Party


Study Sponsor

NYU Langone Health

Study Sponsor

Jill P. Buyon, MD, Study Director, NYU Medical Center, NYU School of Medicine

Verification Date

November 2020