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Seattle Children’s Hospital is about to begin a four-year study focusing on some of their smallest, most fragile patients: newborn babies with heart defects. It’s a study that could lead to a dramatic change in the way newborns are treated.

Dr. Michael Portman is a Pediatric Cardiologist and Director of Cardiac Research at Seattle Children’s, as well as a professor at the University of Washington.

He says they’ve already discovered that the thyroid hormone is diminished after heart surgery, especially in their very young patients. The hormone is important for heart and lung function, so supplementing the thyroid can help babies recover more quickly.

“Every day, every hour that the baby is on the ventilator is a stress on the family, but it’s also a stress on the baby.” says Dr. Portman. “The longer they’re on the ventilator, bad things can happen. They can get an infection, other side effects.”

A few years ago, a study on kids in a larger age range found that the thyroid treatment is safe. In the few newborns in that study, babies under 5-months-old would spend about seven to eight days on a ventilator after open heart surgery. That was trimmed to about three to four days with the thyroid treatment.

But although there’s already a thyroid drug on the market, the Federal Drug Administration doesn’t recognize it as a viable treatment for newborn cardiac patients. So, most of those patients don’t get it.

“That labeling is really important. If it says right on the FDA label this is approved for children undergoing congenital heart surgery, that will really change the standard of care. It would impact probably thousands of infants,” Dr. Portman says.

The FDA has agreed to give the researchers more than a million dollars to conduct this study on newborns to prove to them they should change the labeling.

Now, Dr. Portman says they need to find about 220 babies for the study. That means convincing at least 220 parents that it’s a good idea for their fragile newborn to take part.

The study is being conducted on patients at Seattle Children’s Hospital, LA Children’s Hospital, and at the Lucille Packard Hospital at Stanford University. With about 1,000 newborn cardiac patients between the three, Dr. Portman says he has faith they’ll find plenty of families willing to participate in the research.

Still, it will be more than five years before the FDA approves the re-labeling of the drug, if the study convinces them it’s the right thing to do.

The cardiologists at Seattle Children’s Hospital operate on about 300-400 children each year.

The new study is being funded by a $1.6 million federal grant.