NEW YORK - Repeated courses of a drug that is used to improve the survival of unborn premature babies also may increase the risk of cerebral palsy in those children, according to results from a multi-center study, funded by the National Institutes of Health and led by Ronald Wapner, M.D., professor of obstetrics and gynecology, Columbia University Medical Center and attending obstetrician and gynecologist at NewYork-Presbyterian Hospital/Columbia.
Results of the study are published in the Sept. 20, 2007 issue of the New England Journal of Medicine.
The drug - a corticosteroid called betamethasone - is given to women at risk of premature delivery to hasten the development of their baby's lungs. One course of steroids has been shown to reduce neonatal mortality and improve lung function with little risk to the infant (citation: NIH Consensus Panel on antenatal corticosteroids, 1994).
Up until the year 2000, obstetrician-gynecologists frequently repeated the course of steroids every week, up to 10 to 11 times, in women who remained pregnant after the first course. A NIH panel that year, concerned with the lack of safety data for this practice, suggested multiple courses should be strictly reserved for patients enrolled in clinical trials.
In one of the first such trials to examine the long-term effects of the treatment on the children, women who remained pregnant a week after the initial course of corticosteroids were randomly assigned to weekly courses of corticosteroids or placebo until their babies were born.
The study, performed by members of the NIH-sponsored Maternal-Fetal Medicine Network followed a total of 556 infants at the Morgan Stanley Children's Hospital of NewYork-Presbyterian Hospital/Columbia and 12 other sites around the country, and found that by ages two to three, the two groups of children were physically and neurologically identical, except that six out of 248 children who received multiple courses of corticosteroids had been diagnosed with cerebral palsy, compared to only 1 out of 238 children in the placebo group. The mothers of all six children with cerebral palsy in the corticosteroid group had received four or more courses of the drug.
Although the difference in number of children with cerebral palsy was not statistically significant, Dr. Wapner says that since weekly courses had no long-term benefit and potentially may harm the child, doctors should not administer multiple weekly courses of corticosteroids.
N Engl J Med 357: 12-20
This research was supported by the National Institute of Child Health and Human Development of the National Institutes of Health.