Sanford NICU Now Offering National Clinical Trials
By: Alex Strauss
This summer, Sanford Health extended its clinical trial opportunities to its youngest patients when it was selected to become a member of the National Institutes of Health’s Neonatal Research Network (NRN).
The network was established in 1986 to conduct multi-center clinical trials in neonatal medicine. There are 15 trial sites across the country and Sanford Health is a participating hospital with the University of Iowa. Members of the network design and implement clinical trials across the network for high-risk babies.
Neonatologist and clinical investigator Michelle Baack, MD, will lead the effort for Sanford Health. Infants enrolled in studies at Sanford will be followed after discharge through the NICU’s follow-up clinic led by neonatologist Laurie Hogden, MD. The follow-up clinic will help study the effect of early childhood care throughout the child’s lifetime.
“This is really going to broaden our research involvement,” says Dr. Hogden, who trained at Cincinnati Children’s Hospital, which is also part of the NRN. “The NRN is a group of major large academic centers with large NICUs and they are the leaders in driving neonatal care. For us to be able to participate, is exciting.”
The network seeks to solve the issue that few institutions see more than a few very high-risk babies every year. “By putting large centers together, you suddenly have a lot more babies to study so we could create trials that could involve a lot more infants,” says Hogden. When you have a larger number, you can analyze outcomes statistically.”
Sanford nurse Jennifer Klawitter understands the research value of such a network on more than just a professional level. Two-and-a-half years ago, her daughter Klara was one of those high-risk babies. When Clara was delivered at just 26 weeks, she weighed 1 pound 0.3 ounces.
“She had three doses of surfactant at birth, was intubated for 8 weeks, had eye ablation surgery, a G-tube, and a hernia repair and was on oxygen when she came home,” says Klawitter. “As a parent, I appreciated the fact that every treatment they did for Klara could be backed up with research. They could explain very articulately why one treatment may be better than another based on the research.”
“This is great for Sanford because it elevates our care and our awareness, but it is also exciting for neonatal care in general,” says Dr. Hogden. “When you look at a map of centers involved, the Great Plains is minimally represented. So our involvement will really add to the value of the NRN by enabling it to include a broader range of patients, backgrounds, and genetics.”
In the past, the network has gathered and used data to better understand mortality rates for very low birth-weight babies and the causes of early-onset sepsis. Sanford’s first clinical trial as part of the NRN will examine the use of hydrocortisone as a way to help get NICU babies off of mechanical intervention after preterm birth.
“I am not surprised that Sanford was chosen for this network,” says Klawitter whose daughter now weighs 19 pounds. “I can’t wait for the world to see what they can do here.”