January 26, 2022

Drug touted as aid for premature babies

Rarely these days does an advance in medical technology end up saving dollars as well as lives.

But one such development was enthusiastically endorsed last week by a panel of experts: a simple drug treatment administered to pregnant women to speed the development of fetuses in danger of being born prematurely.

The therapy, involving injections of corticosteroids that cost less than $10 a dose, can save the lives and health of large numbers of babies born prematurely, including many very tiny infants, the panel found after a year of study.

The therapy also can reduce the time that such babies spend in hospitals by about one-third, the panel said. The study projected a “conservative” saving of $157 million a year in initial hospital costs alone, even if the treatment is used in only 60 percent of premature births.

Only about 15 percent of high-risk premature babies receive steroid therapy, the panel said. It recommended that the treatment be used in nearly all pregnancies in danger of ending after 24 and up to 34 weeks of gestation, or six weeks before term.

The treatment is not recommended for pregnancies more advanced than 34 weeks unless there is reason to believe the baby’s lungs are not well developed.

The regimen involves giving pregnant women two intramuscular injections of the corticosteroid drug betamethasone or four injections of a related drug, dexamethasone. The drug, which is injected in the woman, crosses the placenta to the fetus, where it speeds maturation of the fetal lungs and blood vessels.

Ideally, it should be given 24 hours or more before delivery. But even if given within 24 hours of birth, the treatment is beneficial, the panel said, adding, however, that it is pointless to use it when birth is imminent.

Theoretically, the treatment could benefit at least 287,000 babies who are born six or more weeks prematurely each year in this country. At greatest risk are those born weighing less than about 2 pounds.

Many of those infants die soon after birth and many who survive face severe complications, like respiratory distress syndrome and bleeding in the brain, that require long hospital stays and costly treatments and can result in permanent disabilities.

The panel, which held a consensus development conference under the auspices of the National Institutes of Health last week, said its review of well-designed studies showed that nearly all premature babies could benefit from the treatment, with little or no risk to them or to their mothers.

The studies indicated that well-timed steroid therapy could reduce infant deaths by about 40 percent and halve the incidence of respiratory distress syndrome and bleeding in the brain.

Dr. Duane Alexander, director of the National Institute of Child Health and Human Development, estimated that wide use of the therapy could save the lives of 6,000 to 7,000 premature babies each year. And there is also a $3,000 saving for every day that a premature baby does not spend in a neonatal intensive-care unit.

The potential benefits of corticosteroid therapy administered to women in danger of giving birth prematurely was first demonstrated as far back as 1972, but the therapy has been very slow to take hold among obstetricians.

Doctors were reported to be concerned about its overall effectiveness and possible risks, both to mother and infant. The benefits of corticosteroids also were overshadowed by the advent of pulmonary surfactants administered after birth to protect the lungs of premature infants.

However, the expert panel found that even when a surfactant was used, the steroid therapy had an added benefit, speeding maturation of lungs prematurely forced to breathe on their own.

The panel found no evidence of adverse effects on babies exposed before birth to the steroid therapy. Some of those babies have been followed for 12 years, with no evidence of harm.

Nor did the panel find that the treatment placed mothers at risk of complications. Even women treated with drugs in an attempt to stop a threatened premature delivery should receive the steroid therapy, the panel said.

The 16-member panel was headed by Dr. Larry C. Gilstrap, a professor in the department of obstetrics and gynecology at the University of Texas Southwestern Medical Center in Dallas.

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