Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00074373
Status:
COMPLETED
Last Update Posted:
2023-08-03
First Post:
2003-12-11
Brief Title:
The Research Registry for Neonatal Lupus
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
The Research Registry for Neonatal Lupus
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Sjogrens 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 SSARo andor SSBLa proteins The mother may have systemic lupus erythematosus Sjogrens 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None