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Survival improves in clinical trial for severe birth defect, with or without fetal surgery

Newborns with a severe birth defect that hampers lung growth have an equal chance of survival whether they are treated with maternal/fetal surgery or receive their first operation after birth -- if the infant receives life support from the moment of birth from a highly experienced neonatal intensive care team.

Both treatments achieved far better survival rates than earlier standard therapy, according to an NIH-sponsored randomized clinical trial. Results are reported in the November 13, 2003 New England Journal of Medicine.

Pediatric surgeon Michael Harrison, MD, and his colleagues at the Fetal Treatment Center at UCSF Children's Hospital called an early halt to the trial, which evaluated treatment for congenital diaphragmatic hernia (CDH). The trial compared patients who received maternal/fetal surgery with a control group of patients given an advanced form of standard postnatal care. In both groups, fetuses were diagnosed with a severe form of CDH that causes fetal lungs to be dangerously undersized at birth. The control subjects fared surprisingly well -- and that result underscores the need for randomized studies of surgical innovations, the researchers say.

The CDH fetal treatment technique in the trial was developed by UCSF pediatric surgeons. They used a small endoscopic tube, dubbed a fetoscope, to inflate a balloon inside the trachea of a fetus floating in its mother's womb, and stimulate growth of the fetal lungs. At delivery, the newborn's trachea was unblocked and the lungs cleared before the umbilical cord was cut. In this fetal treatment group, 73 percent of infants with severe CDH survived. The control group of newborns with comparably severe CDH were delivered at UCSF and treated from the moment of birth. UCSF neonatologists employed advances in life support for all infants in both groups. In the group given this advanced form of standard postnatal care, the survival rate was 77 percent.

Both results are a
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Contact: Janet Basu
jbasu@pubaff.ucsf.edu
415-476-2557
University of California - San Francisco
12-Nov-2003


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