August 22, 2003

NICU tests drug that could save premature babies

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Steven Steele, RN, gives Jamar Walker, Jr., one-and-and-a-half weeks old, an infusion as part of the MAB-2003 trial. Dana Johnson

NICU tests drug that could save premature babies

A new drug being tested at Vanderbilt Children’s Hospital’s Neonatal Intensive Care Unit might have the power to cut the hospital stay of premature babies, increase survival rates, and address the growing problem of super germs in the nation’s neonatal intensive care units, all at the same time.

Staphylococcus epidermidis — or staph epi, as it’s called — is a bacteria that’s harmless to most healthy children and adults. Staph lives on our skin and on surfaces we frequently touch. If staph epi gets into the blood stream of a premature baby, the results can be devastating, even deadly.

Jamar Walker, Jr. was born on July 14, weighing 2 pounds, 10 ounces. Because of his size, he is at serious risk for a staph infection. Shortly after birth, Jamar’s family was approached by the NICU research staff and asked if they would agree to make Jamar part of a study to test a drug that may help prevent staph infections; a drug currently known as MAB-N003. Jamar’s mother, Maryanne Walker, didn’t hesitate to put him in the study.

“I thought it was wonderful,” said Jamar’s mother, Maryanne Walker. “Our oldest was a 32-weeker. I had her in New Jersey, and she got meningitis at just one day old. That was very scary for us. Maybe this drug could avoid things like that.”

Some are calling MAB-N003 “the staph vaccine,” while others describe it as a drug that prevents staph in much the same way another relatively new drug, called Synergis, prevents the serious respiratory infection Respiratory Syncytial Virus (RSV) in preemies.

MAB-N003 is a manufactured version of a natural part of the human immune system that fights staphylococcus bacteria by keeping it from adhering to healthy cells. It also acts as an antigen to Lipoteichoic acid, called anti-LPA. Lipoteichoic acid is a toxin produced by staph. It’s the toxin that causes damage to a baby’s body during a generalized staph infection. If the toxin can be neutralized by anti-LPA, babies could achieve a much higher survival rate, and faster recovery.

“Staph organisms are responsible for about 50 percent of the infections in our nursery,” said Steven Steele, RN, and a research nurse in the Division of Neonatology. “That’s why this new drug we are testing is so important. If we could reduce hospital-acquired infections it would be a great thing.”

On July 24, Jamar received his second infusion of the experimental drug as part of the phase two study of MAB-N003. The fluid that is put into his veins is either a placebo, or the drug itself.

Jamar will get one infusion a week for three weeks, then research nurses will follow Jamar for 56 days, drawing tiny samples of blood up to day 42. It’s hoped this study will determine what dose of anti-LPA works best, and for which babies.

Right now the only prevention for staph infections is scrupulous hand washing and equipment sterilization.

“But staph epi lives on the skin at all times. Even if you go and wash your hands it’s still there,” said Steele. “So unless you remove human involvement there’s no way to eliminate the risk.”

Babies in the NICU are sometimes called million dollar babies because they often have to stay for months, receiving intensive care at great expense. Staph infections are part of the reason some babies stay so long.

“At minimum, a staph infection is going to set a baby back several days,” said Steele. “If they were feeding, we might have to stop their feeding, if they were weaning off the respirator or off oxygen, they might actually have to go back on the oxygen or on the ventilator.”

One day of ventilator costs could outweigh the cost of the drug.

“The vent is about a thousand dollars a day,” said Steele “So if you save a few ventilator days or hospital days you’ve recouped your cost of the drug.”

At term, a baby naturally has plenty of anti-LPA. They get a nice infusion of it from their mother in the final six weeks of pregnancy.

“So most of these premature babies miss out on that,” said Steele.

“This would be the perfect answer,” said Dr. William Walsh, professor of Pediatrics and Chief of Nurseries for VUMC. “The Staph epi only responds to Vancomycin anymore. It’s the last drug we have that’s useful against it.”

Using more antibiotics to fight more and more resistant germs is a major concern worldwide. That’s why studies like this one are so exciting.

“This makes much more sense than trying to come up with more powerful antibiotics to kill it,” Walsh said.

But parents only know it’s exciting to have more help to save premature babies.

“It’s a 50-50 chance that he’s getting the concoction,” said Steele. “Even if he’s getting the placebo he’s helping out the study and it might get him home faster. I’d do anything to make the babies more comfortable.”

Jamar is doing well on his own anyway, and if he is getting the experimental drug, it will only stay in his system for a few weeks to a few months. Just long enough to get him home, hopefully before his original due date in September.

“Once these kids go home the risk of staph infections drops to zero,” said Steele. “Moms aren’t starting IVs or doing procedures on them.”

The Vanderbilt Children’s Hospital study started in June. Fewer than a dozen babies have been enrolled so far, but more parents are being asked if they would let their babies participate.