Release Date:  March 15, 2001

NOTICE:  NOT-HD-01-006

National Institute of Child Health and Human Development

The National Institute of Child Health and Human Development (NICHD) 
announces the addition of a research program to its existing Maternal Fetal 
Medicine Unit Network.  This program is designed to evaluate in utero fetal 
surgery as a treatment for antenatally diagnosed spina bifida in a randomized 
clinical trial.  Open neural tube defects are the most common severe central 
nervous system congenital anomaly, affecting approximately 4000 fetuses in 
the United States each year.  Commonly, open neural tube defects are 
identified antenatally with an abnormal maternal serum alpha-feto-protein 
test (done at 15-20 weeks gestation) and obstetrical sonography.  Until 
recently, the management of this condition was expectant through pregnancy, 
with prompt correction in the neonatal period to avoid infection and further 
damage to open neural tissue.  However, both animal models and clinical work 
have demonstrated that in utero repair is possible via maternal-fetal 
surgery.  Repair in utero may improve outcome by preserving neurologic 
function and preventing the sequelae of ventriculomegaly and the Chiari 
malformation.  With the information available, in utero therapy has not 
demonstrated neurologic improvement, but does suggest a decreased need for 
shunting and Chiari malformation.

An increasing number of these procedures are being done, despite the fact 
that in utero surgery has not been validated to show improvement over 
postnatal repair.  To address this urgent research need, a limited 
competition to participate in this program is established for institutions 
with the experience, patient base, systems, and resources necessary to 
participate in a randomized clinical trial. The objective is to establish a 
network of Fetal Surgery units that can, through rigorous patient evaluation 
using a common protocol, study the required numbers of patients and provide a 
valid answer more rapidly than individual centers acting alone. 


Susan C. Streufert, Ph.D.
Extramural Policy Officer
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 4A01, MSC 7510
Bethesda MD 20892-7510
Telephone:  (301) 435-6856

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