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As the opioid crisis continues to impact communities across the world, a physician-scientist at USA Health has been named the principal investigator of an international phase II clinical trial to evaluate the safety of a drug for babies born with neonatal opioid withdrawal syndrome.

Published Jul 10th, 2020

By Casandra Andrews

Richard M. Whitehurst Jr., M.D., professor of pediatrics and assistant professor of pharmacology at the University of South Alabama College of Medicine, was selected by Chiesi Farmaceutici of Parma, Italy, to lead a five-year multi-center study spanning at least 19 clinical locations in the United States and abroad.

Use of opioids during pregnancy can result in a drug withdrawal syndrome in newborns called neonatal abstinence syndrome or neonatal opioid withdrawal syndrome. An analysis of the extent and costs of the syndrome found that it’s rising in the United States, according to the National Institute on Drug Abuse. From 2004 to 2014, an estimated 32,000 infants were born with neonatal abstinence syndrome, which is equivalent to one baby suffering from opioid withdrawal born every 15 minutes.

Whitehurst and other clinical staff in the department of pediatrics at USA Health have participated in previous studies with Chiesi related to neonatal opioid withdrawal syndrome, previously known as neonatal abstinence syndrome.

The study is a double blind, randomized, two-arm parallel study to evaluate the efficacy, safety and pharmacokinetics of CHF6563 in babies with neonatal opioid withdrawal syndrome, said Ellen Dean, RNC, the neonatal intensive care unit (NICU) research study coordinator at USA Health Children’s & Women’s Hospital.

This summer, Whitehurst and NICU staff will begin enrolling infants that were exposed to opioids during the last month before delivery, Dean said.

“Unfortunately, the rates are high across the nation for babies who are suffering because they are born with opioid withdrawal syndrome,” Whitehurst said. “We want to find the best methods possible to help those babies through a variety of measures and protocols.”

Research shows newborns with the syndrome are more likely than other babies to have low birthweight and respiratory complications. Nationally, rates of opioid use disorder at delivery caused hospitalizations to more than quadruple from 1999 to 2014, to 6.5 per 1000 births in 2014. That year, $563 million was spent on costs for treatment of the syndrome, the National Institute on Drug Abuse reported.

Whitehurst, who begins visits with mothers as part of the prenatal care team prior to childbirth, has a long history of building successful relationships with parents before they deliver, Dean said, to help ensure the best outcomes for babies. Because of other protocols established by Whitehurst, the length of stay for newborns withdrawing from opioids and other drugs has decreased significantly in the past five years at USA Health Children’s & Women’s Hospital.

“We’ve adopted non-medication treatments, such as swaddling the babies differently, adapted the light and noise levels so they are not over stimulated, and taught parents how to care for them when they go home,” Dean said.

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