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.”

“Pregnancy is a real window for these mothers. If there’s ever a time that they will be motivated to make a positive change in their lives, it will be during this time when they can do something for their baby. We want to empower them to do that.”

A WINDOW OF OPPORTUNITY

The program’s focus isn’t just on preventing withdrawal; it’s also about more time with mom. It has evolved to address the fears of mothers and provide a positive birth experience that comes with its own long-term benefits for both mom and baby.

As special project coordinator for the Children’s Hospital at Prisma Health-Upstate, Landrum Knight is often the first point of contact for mothers referred to the MAiN program. Moms who are new to the program understandably come in with concerns related to their child receiving methadone, and Knight helps them understand that there is no one-size-fits-all solution administered to each child.

“It usually sets them at ease to learn that some infants who go on what we call ‘watch and see’ protocol don’t even end up needing medication, but for those that do, we are there to monitor and administer it before the pain begins,” Knight says. “Mothers who have gone through withdrawal want nothing more than to keep their infants from experiencing it.”

Knight works to also dispel misinformation that most mothers have upon entering the program. Mothers often think there is some punitive aspect to the program or that they’ll lose their child, while others have more specific concerns about their ability to breastfeed.

Before and after birth, the team is there to provide as much education as possible so that mothers become an integral part of the baby’s care. Hudson says this is vital for the success of infants but also for the continued success of mothers, both in their journey to overcome addiction and to become successful parents.

“Pregnancy is a real window of opportunity for these mothers,” Hudson says. “If there’s ever a time that they will be motivated to make a positive change in their lives, it will be during this time when they can do something for their baby. We want to empower them to do that.”

Feedback from mothers has been overwhelmingly positive. Hudson says there are three women who have had their third baby in the program, while many more have had two. A big part of why they stick with it is because they know it’s a medical experience that is free of judgment.

The length of a mother’s treatment varies depending on her specific life circumstances and medication needs. Some mothers can wean from opioids within weeks of giving birth, while others will need to remain in treatment for years or for the rest of their lives.

One mother — who requested to remain anonymous — entered the program well into her third trimester after difficult experiences with other physicians.

“I missed appointments during months four to six because of stress and anxiety and complete exhaustion,” she says, “but I was relaxed once I was accepted as a patient [in the MAiN program]. No one shamed me, and that is huge for an addict, but especially for a pregnant addict who continues in daily recovery. They accepted me.”

A LARGER IMPACT

Lori Dickes, associate professor and director of Clemson’s master of public administration program, analyzes the project’s broader economic impact. She says that a mom and baby “graduating” from the program at a successful three-month checkup can have a big downstream effect.

“Creating a system of care in which mothers feel less judged and more supported is better for all of us,” Dickes says. “The hundreds of mothers and children who’ve benefited from this program will have a more positive view of health care, and they’ll be more likely to make their health a priority; the longer-term spillover effects are substantive.”

The evidence supporting the immediate and lasting positive impacts for mom and baby grow with every infant born in the MAiN program, as does the evidence that the program is simply smart for hospitals to employ.

Infants who don’t have to be admitted to NICUs free up space for other newborns in need and ease the workload of NICU doctors, nurses and staff. Infants in the program are also far less likely to be evaluated in emergency rooms for withdrawal symptoms after discharge from the hospital. Almost 90 percent of infants in the program are covered by Medicaid, so savings are ultimately passed on to taxpayers; the research team estimates that hospitals save approximately $89,400 per birth.

“According to research, the biggest proverbial bang for society’s buck is with children or infants,” Dickes says. “If we can get babies and children off to a healthy start, then everybody wins. This project is showing that from an economic standpoint, the approach developed by the MAiN program is good for our communities and not just individuals.”

Even though the data was promising, the team wanted to provide even more backup for the program’s effectiveness by conducting a pilot program at another Upstate hospital. Hudson says that even in a smaller hospital with less resources, outcomes in the pilot program were the same or better for mothers and infants.

The pilot program also revealed ways in which expansion to other hospitals could be made easier for hospital staff. A half-day training session was expanded to a six-hour, web-based training module that addressed feedback gathered during the pilot. Training includes video instruction and training materials provided directly by members of the MAiN team.

Thanks to the pilot and the data collected, the Department of Health and Human Services provided more funding through 2022 that will allow the MAiN program to expand to 10 hospitals across the state. Mayo says MAiN data compared to state and national data helped make the case for expansion.

“We’ve shown the program to be effective at Prisma Health and during the pilot program, so we look forward to seeing how the program is implemented across the state,” Mayo says. “The opioid epidemic is a nationwide issue, so we’d like to come together with even more health care systems and academics to spread the positive results and lessons learned in this program as it is refined in the coming years.”

The first children who graduated from the MAiN model of care are now in their early teens, so researchers will also begin looking at the long-term outcomes they’ve experienced. The team is particularly interested in any developmental issues — or lack thereof — that might be tied to participation in the program compared to long-term outcomes in other children.

The program has come a long way since 2003, and it can all be traced to one person’s well-developed sense of empathy. Hudson never anticipated that a method she decided to experiment with out of frustration might be expanded across the state and considered across the nation. She also never anticipated being as affected by the relationships she’s established with moms in the program.

She says one of her primary goals when working with them is to reinforce good behavior. Sometimes that’s as easy as Hudson taking the time to tell a mom that she’s proud of the choices that she’s making for herself and her soon-to-be-born child. Last year, that simple phrase elicited a response that reminded Hudson again that she was on the right track.

“All I said to the mother was, ‘I’m proud of you,’ and she just broke down in tears,” Hudson says. “She told me that no one had ever told her that before. It broke my heart. Every mother deserves to hear that, just like every mother and child deserve to have a positive birth experience. It can be tough for anyone, and it shouldn’t be any tougher for them.”

The program’s focus isn’t just on preventing withdrawal; it’s also about more time with mom.

Michael Staton is communications and media manager in the College of Behavioral, Social and Health Sciences and the College of Education.

3 replies
  1. Maria Cira says:

    What a wonderful program! The opioid epidemic is not going away anytime soon. The MAiN program gives the appropriate help to the innocent infant victims as well as their mothers. Well done Tigers!

    Reply
  2. Glenda says:

    Loved this story. I feel for these babies and so thankful for the help they are getting. Jennifer is awesome.

    Reply
  3. Laura McGinnis says:

    I think it awesome how the health care industry and Clemson were able to partner together to bring about a better outcome for these babies and their moms. CLEMSON PROUD!

    Reply

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