You are a woman with anti-SSA/Ro and/or anti-SSB/La autoantibodies and have a child with any problem of NL You are a child with with any problem of NL born to a mother who tested positive for anti-SSA/Ro and/or anti-SSB/La autoantibodies.

Research Registry for Neonatal Lupus (RRNL)

We appreciate that you are considering enrolling in this project and are willing to participate in our research. It is our pleasure to invite you to enroll in the National Research Registry solely devoted to neonatal lupus. This registry is being supported by funds from the federal government and represents a major step toward finding answers to this rare disease. The aims of this special registry are to collect data on as many patients as possible and to foster collaborative efforts with researchers across the country. The long-range goal is to find ways to prevent and treat this unusual condition that affects children.

Your participation will involve reading and signing a consent form, completing an enrollment questionnaire, completing request for the release of medical records forms, and donating a blood sample. You will consent your minor NL-affected child/children under your consent form, and sign RRMRs for physicians managing their care.  We will request a donation of either their blood or saliva.  (See Section B. Subject Participation on the Consent Form beginning on page 2)
If you feel you meet the enrollment criteria and would like to participate in this research project you can either contact us directly by clicking here or downloading the three forms listed below, completing them and mailing them to us click here for mailing address. (Note: You will need to print and complete a sufficient number of the RRMRs for the physicians participating in your care.  (See item 3 below)

1. Read and sign the Informed Consent Form to Participate and Authorization for Research (consent form).  (Note: Please also initial and date each page of the form)
2. Fill out the enclosed enrollment questionnaire that has been approved by a committee of experts in the field.
3. Sign the requests for release of medical records (6 copies) and return them, along with the consent for participation and the questionnaire.  We will communicate with your doctors directly for medical records.  The most important records we want are from:
   1. The obstetrician who took care of you during the pregnancy of your child with neonatal lupus.
   2. The pediatric cardiologist of a child who has heart block, or the pediatrician, or dermatologist who diagnosed a child’s skin rash.  Please fill in your child’s name, date of birth, and social security number on the request, and also sign your name as the legal guardian.
   3. Your own medical doctor, preferably a rheumatologist, if you have one.
   4. Hospital discharge records (for both you and the child) at the time of release after delivery of the child who has neonatal lupus.

We will then send a signed release form to each doctor identifying the specific records we are interested in obtaining.

Upon receipt of your completed forms we will mail you a Blood Collection Kit.  Please indicate if your child/children will donate a blood or saliva sample.  We will provide a pre-paid DHL airbill to return the kit(s) to us.

1. Enrollment Questionnaire
2. Consent Form
3. RRMR

If you come across any families affected by neonatal lupus (skin rash or congenital heart block), it would be a tremendous help to this research if you would refer us to them. 

If you have any questions, please do not hesitate to send us an email zoey.smith@nyumc.org or call at 212-263-2255. 

Thank you for taking the time to make this project a continuing success.