Contrary to popular belief, phenobarbital is not effective in preventing brain hemorrhages in premature babies. Seetha Shankaran, MD, professor of pediatrics, published these findings in the August 14 New England Journal of Medicine.
Early clinical trials in the 1980s suggested that phenobarbital might reduce the frequency and severity of the bleeding, which occurs in approximately 10,000 premature babies each year. In a clinical trial of 610 pregnant women who were at high risk for early delivery, the National Institute of Child Health and Human Development’s (NICHD) Neonatal Research Network with Dr. Shankaran as principal investigator found no difference between the control group and the mothers who took phenobarbital. In both groups, 23 percent of the infants had hemorrhages.
Researchers originally thought the benefits of phenobarbital might transfer to preemies, because it is used to treat pediatric epileptic seizures by sedating or dampening the parts of the brain that signal seizures to occur. Taking it one step further, physicians thought it may prevent fluctuations in blood flow and protect against brain injuries.
"Years ago, I did two studies on phenobarbital which suggested the drug had benefits, but recent studies have gotten larger and more sophisticated, painting a more realistic picture," said Dr. Shankaran.
The Wayne State University School of Medicine, Children’s Hospital of Michigan, and Hutzel Hospital are part of the Neonatal Research Network, which is funded by the NICHD. These research centers are further analyzing Dr. Shankaran’s data and posing subsequent research questions. There is some speculation that phenobarbital may be helpful only to babies with very, very premature births. These questions are expected to yield future studies.
In the meantime, Dr. Shankaran is continuing with a number of research projects including the following: indomethacin as a possible prevention against neurological complications in infancy, a drug to reduce the number of transfusions in premature babies, nitric oxide gas as a prevention for respiratory failure for babies in the neonatal intensive care unit, and novel ventilation management methods to reduce chronic lung disease in children on ventilators.
"We’ve come a long way in helping premature babies survive," said Dr. Shankaran. "The challenge now is to give them the healthiest start possible."