UAMS, Duke to partner on infant opioid withdrawal syndrome trials

The University of Arkansas for Medical Sciences (UAMS), in collaboration with the Duke Clinical Research Institute, has received a $1 million federal grant for two clinical trials involving infants with neonatal opioid withdrawal syndrome (NOWS).

The increase in maternal opioid use has resulted in a rise in the number of infants born with NOWS. The $1,066,433 in funding comes from the National Institutes of Health (NIH) Helping to End Addiction Long-term (HEAL) Initiative SM, an aggressive, trans-agency effort to speed scientific solutions to stem the national opioid public health crisis.

At UAMS, Jeannette Lee, Ph.D., professor of biostatistics, and Jessica Snowden, M.D., associate professor of pediatrics, are leaders of the Data Coordinating and Operations Center for the Environmental influences on Child Health Outcomes (ECHO) IDeA States Pediatric Clinical Trials Network. The network will conduct the trials in conjunction with the Neonatal Research Network, which is funded by the Eunice Shriver Kennedy National Institute for Child Health and Human Development. Both trials aim to address management of infants exposed in utero to opioids.

“The two clinical protocols that we will be testing were developed over a two-year period through collaboration among the clinical sites and coordinating centers that are a part of this united effort,” Lee said. “In both instances, we are looking for new, improved tools for treating these infants, who are born with the physical symptoms of opioid withdrawal.”

One study will evaluate an innovative approach called “Eating, Sleeping and Consoling” for its effectiveness in caring for NOWS infants, as measured by decreased length of hospital stay compared to usual care. The other study will examine a rapid schedule of weaning NOWS infants from opioid replacement therapy to determine if it shortens the weaning period compared to usual care.

Both trials are scheduled to launch this year.

Symptoms of NOWS, which was previously known as neonatal abstinence syndrome, can include high-pitched crying, irritability, exaggerated reflexes, altered sleep-wake cycles, tremors, seizures, vomiting, loose stools, poor feeding, sweating, sneezing and temperature instability. Treatments often include kangaroo care skin-to-skin contact with caregivers; calm, dark, protective environments; and medication-assisted treatment like the drug methadone for opioid withdrawal.