New Research [Closed to enrollment at current dose.]
Preventive IVIG Therapy for Congenital Heart Block (PITCH Study)-
Sponsored through peer reviewed grant from the Alliance for Lupus Research
The research team working on Neonatal Lupus Congenital Heart Block, including
the Research Registry of Neonatal Lupus, under the direction of Dr. Jill P.
Buyon, is pleased to announce the launching of a new research opportunity. We
have assembled the resources to embark on a trial of prophylactic treatment to
try to prevent congenital heart block BEFORE it begins. Everyone can get
treated – there is no placebo or “dummy” group.
The challenge of this project is that we need to enroll patients who have had a
prior affected child with heart block or rash, in whom the recurrence rate is 1
in 5, BEFORE the 2 month pregnancy point. In other words, as soon as a woman
with a previously affected child knows she is pregnant, and before 12 weeks of
gestation, we need her full participation. WE NEED YOUR HELP!
The study involves receiving 5 separate infusions of intravenous immune
globulin, a human blood product, beginning at about 2 months of pregnancy and
continuing every few weeks through the 7th month. Some extra blood specimens
will also be obtained from you on these occasions. The product has been used
for many years during pregnancy and is safe. The rest of your health care will
follow the rigorous, close monitoring, including fetal echocardiograms, which
we recommend in such pregnancies. There is no charge to you.
This study, although time consuming on your part and involving extra blood
sticks and drug infusions, has the potential to protect your fetus from the
nearly 20% chance (1 in 5) of developing a very serious heart condition,
congenital heart block, at very low risk.
Download "PITCH" in
pdf 
If you are interested or simply want more information, please contact:
jill.buyon@nyumc.org
Jill P. Buyon, M.D., Rheumatologist
212-263-0746
jill.buyon@nyumc.org
Deborah M. Friedman, M.D., Pediatric Cardiologist
914-594-4370
deborah_friedman@nymc.edu
Thank you for your cooperation, and we look forward to hearing from you.
Jill P. Buyon, M.D.
Deborah M. Friedman, M.D.
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