By Michael Staton
Photography by Craig Mahaffey
Clemson researchers play an instrumental role in expanding a program that spares infants the pain of opioid withdrawal
One word is constant when adults describe opioid withdrawal: pain.
Fever, seizures, hyperactive reflexes, vomiting, diarrhea, sweating, dehydration and little-to-no sleep are the guaranteed symptoms that contribute to this pain and why most can’t make it through opioid withdrawal “cold turkey.”
The same set of symptoms applies to some infants exposed in utero to opioids taken by substance-dependent mothers. These infants are born with neonatal abstinence syndrome. The high-pitched crying and trembling make breastfeeding or bonding with a mother more difficult, and seizures can lead to lack of oxygen and even death if unrecognized.
Common practice for adults experiencing opioid withdrawal is treatment with a drug such as methadone, with a gradual dose reduction to alleviate symptoms. However, the standard of care for infants has been to wait for sufficient signs of withdrawal symptoms before providing the child with medicine. Typically, infants are admitted to a neonatal intensive care unit (NICU) immediately after birth or once withdrawal symptoms are severe enough to warrant medication. Either way, they’re destined for the harrowing experience of withdrawal.
This was reality for Jennifer Hudson, a physician and medical director of newborn services at Prisma Health-Upstate in Greenville, South Carolina. She could predict with startling accuracy what would happen to infants who were exposed in utero to methadone. By day three or four, their intense withdrawal symptoms became as predictable and routine to her as the frustration she felt standing by and waiting for it to happen.
“After a few years of adhering to this standard, the approach just started to feel impractical and unethical,” Hudson says. “If the suffering of an infant wasn’t enough of a reason to be more proactive, then there’s the list of other long-term problems withdrawal creates that hospitals have to fix.”
Hudson decided to break the cycle. In 2003, she began offering mothers prophylactic treatment for their methadone-exposed infants in order to curb withdrawal symptoms. It proved to be a reliable way to get infants out in front of the damage that withdrawal could cause, and people began to notice the positive results.
Colleagues and representatives from state agencies encouraged Hudson to publish her work so that the benefits from this approach would not remain with one population and one hospital system. She received funding from the South Carolina Department of Health and Human Services to better illustrate her approach’s efficacy and safety, so she knew she needed data to make her case.
“I couldn’t just go to hospitals and say ‘I’m doing this really cool thing. I think it’s safe and you should do it, too,’” Hudson says. “I was not trained to do research and was a little afraid of that part, but when Clemson got involved that all changed. They have been incredible research partners, and this project wouldn’t be where it is now without them.”
Hudson’s collaboration with researchers from Clemson’s College of Behavioral, Social and Health Sciences would help inform the Managing Abstinence in Newborns (MAiN) project that Hudson had been spearheading at Prisma Health since 2012. MAiN is now being expanded to multiple hospitals across South Carolina, but handing it off to doctors and staff unfamiliar with the approach isn’t as simple as sharing the directions for use found on the back of a medicine bottle.
The MAiN team has developed a curriculum for partner hospitals that addresses the immediate needs of infants and then educates, supports and encourages mothers to prioritize their health and the health of their children in the long term. Thanks to research from Clemson faculty, there’s mounting evidence that this approach benefits mom and baby as well as hospital systems and surrounding communities trying to keep the negative effects of an opioid epidemic at bay.
THE RESEARCH CHALLENGE
It can be easy to rush to judgment about the mothers involved in the MAiN project. However, like most of the tragic stories that have come from the opioid epidemic in the U.S., there is no single path to addiction and no easy villain at which to point a finger.
Rachel Mayo, professor in Clemson’s public health sciences department, admits that even she had to check her emotions as a mother at the door when she was first introduced to the work Hudson was doing in 2012 when she was brought on board to inform Hudson’s work with research. Any preconceptions she had of these mothers were quickly removed when she saw the similarities across their stories.
“As soon as I dug in, I realized they were just people who fell victim to the usual story of opioid addiction,” Mayo says. “They had an accident or were injured, they were prescribed opioids, they became addicted to a highly addictive drug and then they got pregnant.”
Mothers involved in the MAiN program are typically in treatment for their own dependency, and quitting cold turkey is not advised for pregnant mothers due to the toll withdrawal takes on the mother’s body and the baby in utero. Mayo, who has previously specialized in research involving women’s health and cancer prevention, said she was immediately attracted to the project not only from a women’s health standpoint, but also because of the growing nationwide prevalence of neonatal abstinence syndrome.
The National Institute on Drug Abuse estimates that 32,000 babies born in the U.S. developed neonatal abstinence syndrome in 2014, which was a fivefold increase since 2004. That’s a baby born every 15 minutes who will experience opioid withdrawal, and opioid use has yet to plateau in the U.S.
The “big picture” was clear enough to Mayo, but the project needed specific, accurate data to determine the effectiveness of Hudson’s approach in the Upstate South Carolina population. With the added gray area that comes along with a stigmatized population such as substance-dependent mothers, the challenge in data collection became that much greater.
“Mothers are understandably afraid to self-identify for fear that their child will be taken from them, so infants would wind up in NICUs too late, or they were leaving hospitals before withdrawal symptoms occurred and coming back through emergency rooms,” Mayo says. “We needed good, solid numbers, and there were a variety of factors that made that tricky.”
Mayo, along with the Clemson team and Hudson’s staff, began pulling data from years of medical records related to pregnancies. To account for those mothers and babies who might have fallen through statistical cracks, they looked back also at emergency room readmission data 30 to 60 days after birth in order to paint as accurate a picture of the data as possible.
Clemson researchers began to also analyze the protocols developed by Hudson’s team, including the standardized plan of care for mothers in the program as well as the data they were capturing from mothers and infants. These tweaks would go on to improve future data collection and analysis of the MAiN protocol.
Mayo says that while the hunt for accurate, reliable data was difficult, it was plain to see that Hudson’s approach was working for infants. The approach was also becoming more reliable as the physicians and pharmacologists zeroed in on a methadone wean that was effective for each infant. Since 2012, 90 percent of mothers whose newborns qualified for early treatment have chosen the MAiN protocol.
Those infants have avoided devastating weight loss that comes from burning calories in withdrawal and the disorganized feeding skills that emerge from not eating or having time to bond with their mother. They have avoided both the special protocols to address bleeding caused by diaper rash and a need for long-term physical therapy required to help the infant finally relax after the trauma of withdrawal. They have avoided pain.
“For me, the most exciting thing was seeing that babies receiving this treatment did the same or better than those that went to NICUs,” Mayo says. “This approach would be extremely successful if it were just limited to medical outcomes, but there are many more benefits.”
“Mothers are understandably afraid to self-identify for fear that their child will be taken from them.”
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