GREENVILLE, S.C. – Greenville Health System (GHS) and Clemson University are collaborating on research into an innovative treatment method for opioid-dependent newborns that significantly improves outcomes and reduces withdrawal symptoms by beginning low-dose medication within 24 hours of delivery – well before significant withdrawal symptoms can begin.
The therapy proactively targets symptoms associated with Neonatal Abstinence Syndrome (NAS), the drug-withdrawal syndrome that can be devastating for newborns and is caused by the mother’s opioid use during pregnancy.
The early-therapy approach – which was developed and piloted at GHS – will be expanded to up to 10 additional hospitals in S.C. this year. The initial sites are expected to be announced in mid-February. The ground-breaking initiative is being funded by the S.C. Department of Health and Human Services (SCDHHS).
“Neonatal abstinence syndrome is one of the staggering human costs of the opioid crisis, one that affects South Carolina’s youngest and most vulnerable,” said Joshua Baker, the SCDHHS’ interim director. “The MAiN program is yet another example of South Carolina’s national leadership in developing standards of care that give infants the best start at life, ultimately leading to better health outcomes,” he said. The agency provided $1.2 million to initially grow and analyze the program and has committed another $2.5 million over the next five years for the expansion.
The pilot results have been “extraordinarily encouraging,” said Jennifer Hudson, M.D., medical director of newborn services at Greenville Memorial Hospital. Hudson pioneered this approach 14 years ago at Greenville Memorial after seeing firsthand the suffering of newborns.
“To have these babies suffer – when we can ease or even eliminate it – is cruel and unnecessary,” said Hudson. “Newborns deserve early and effective treatment for Neonatal Abstinence Syndrome just as much as they do for non-drug-related pain.”
Hudson and physician researchers at GHS are working with researchers in Clemson’s public health sciences department to study the safety, efficacy and cost of this palliative approach to treating opioid-dependent newborns. Their research findings have already been published in the American Journal of Perinatology (December 2016) and Population Health Management (May 2017).
By proactively beginning an opioid wean with babies at highest risk for NAS, doctors minimize the likelihood of babies experiencing the severe pain, suffering and potential health complications that come with full drug withdrawal. The Managing Abstinence in Newborns (MAiN) program proactively treats the babies with low-dose medication within 24 hours of birth instead of waiting for them to show significant symptoms of withdrawal. During full-blown withdrawal, a baby typically experiences tremors, crying, difficulty sleeping, feeding problems, vomiting, liquid diarrhea and extreme weight loss. Seizures may also occur. Adults in full opioid withdrawal describe it as one of the most painful experiences of their lives.
Babies in the MAiN program are typically hospitalized for only one week. Babies are treated while rooming-in with their mothers, which strengthens bonding opportunities and also paves the way for staff to provide additional education to the mothers. Babies are weaned from medication over two to four weeks after discharge, with follow-up monitoring through weekly physician visits and in-home nursing visits.
In contrast, the traditional medical approach doesn’t start treatment until the newborn is approaching full withdrawal, which means babies are in more discomfort and require more complicated interventions which can only administered in a higher-acuity setting like a neonatal intensive care unit. Parents are minimally involved in the care process and treatment decisions. Once symptoms are controlled, babies are slowly weaned off higher-dose medications while still in in the NICU. Typically, the process takes anywhere from three weeks to three months.
The first-of-its-kind MAiN model is the only one that combines nursery-based early treatment and inpatient stabilization with outpatient weaning. Babies avoid the high-acuity neonatal intensive care setting altogether.
Opioid use is skyrocketing in S.C., which ranks in the highest quartile among states for the number of painkiller prescriptions per 100 people and has seen prescriptions increase each year, according to the CDC. Opioid-related deaths across South Carolina jumped from 237 in 2013 to 516 in 2014; and, in 2015, more than 600 people died from opioid and heroin overdoses.
“The MAiN model will help hospitals keep babies healthier and closer to their families and support systems in their communities. It also keeps more NICU beds open for those infants needing true critical care,” said Hudson. “We think that our new model can benefit hospitals – and most important, families, moms and babies – all over the country in the future.”
Clemson researchers compared the health outcomes of babies in the MAiN program versus the outcomes of babies who received traditional NAS care at other S.C. hospitals and found that babies treated with the innovative approach had no increases in emergency department visits or readmission rates. Parents also report having high levels of participation and satisfaction with the program.
GHS and Clemson researchers estimate the expansion program could save millions in healthcare expenditures over the first five years, particularly by reducing newborn intensive care unit time for these newborns. From 2006-2014, average charges for NAS infants in the MAiN program at GMH were under $11,000 compared to an average of $45,000 for traditional-care NAS infants statewide and almost $60,000 for NAS infants nationwide.
“This program has the potential to dramatically improve the birth outcomes for babies born with neonatal abstinence syndrome around the state,” said Rachel Mayo, PhD, a professor in Clemson’s public health sciences department and lead co-investigator. “This expansion represents an incredible opportunity to help hospitals reduce length of stay and costs associated with an NAS birth,” she said.
GHS researchers include Hudson, Bradley Dalton, MD, and Kindal Dankovich, MD. Clemson investigators included Mayo; Windsor Sherrill, PhD; Lori Dickes, PhD; Liwei Chen, MD, PhD; and Julie Summey Bedi, EdD. Additional research and evaluation will occur as the program expands in S.C.
“By leveraging clinical expertise at GHS with Clemson faculty research expertise, we hope to provide a palliative care model that will help transform care for newborns nationwide,” said Windsor Sherrill, PhD, GHS chief science officer and associate vice president for health research at Clemson.