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The Research Registry for Neonatal Lupus

This study is currently recruiting participants.
Verified October 2017 by New York University School of Medicine
Sponsor:
ClinicalTrials.gov Identifier:
NCT00074373
First Posted: December 12, 2003
Last Update Posted: October 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
New York University School of Medicine
December 11, 2003
December 12, 2003
October 13, 2017
September 1994
January 2020   (Final data collection date for primary outcome measure)
means of curing and/or preventing neonatal lupus [ Time Frame: ongoing ]
means of curing and/or preventing neonatal lupus
Not Provided
Complete list of historical versions of study NCT00074373 on ClinicalTrials.gov Archive Site
identification of pathogenesis of neonatal lupus [ Time Frame: ongoing ]
identification of pathogenesis of neonatal lupus
Not Provided
Not Provided
Not Provided
 
The Research Registry for Neonatal Lupus
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
Blood
Non-Probability Sample
Women with a child affected by neonatal lupus, children affected by neonatal lupus, siblings of children affected by neonatal lupus, siblings of women with a child affected by neonatal lupus, fathers and maternal grandparents of children with neonatal lupus, and unaffected people to serve as controls are invited to participate in this study.
  • Neonatal Lupus
  • Systemic Lupus Erythematosus
  • Sjogren's Syndrome
  • Congenital Heart Block
Other: No intervention; observational
Other Name: The study is observational
human beings
human beings of all sexes, ages, and health statuses
Intervention: Other: No intervention; observational

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
January 2020
January 2020   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
Child, Adult, Senior
Yes
Contact: Zoey Smith 212-263-0743 zoey.smith@nyumc.org
Contact: Jill Buyon, M.D. 212-263-0746 jill.buyon@nyumc.org
United States
 
 
NCT00074373
09-0289
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
New York University School of Medicine
New York University School of Medicine
Not Provided
Study Director: Jill P. Buyon, MD NYU Medical Center, NYU School of Medicine
New York University School of Medicine
October 2017