In hospitals across the country, the standard procedure for babies exposed to opioids can best be described as “wait and see.” Newborns are often kept in a neonatal intensive care unit (NICU), to see if they experience the extremely painful withdrawal symptoms related to Neonatal Abstinence Syndrome (NAS).
Only if those withdrawal symptoms begin, the NICU will begin treating the newborn with methadone to ease the withdrawal. And all the while, the babies live apart from their mothers, sometimes for weeks.
Dr. Jennifer Hudson, medical director for newborn services at the Greenville Health System, sees the approach as unnecessarily painful for children and believes it places the future bond between mother and baby in jeopardy. So she developed an alternative protocol.
Under the Managing Abstinence in Newborns (MAiN) program, children at Greenville’s children’s hospital who are at high risk for withdrawal – generally those exposed to long-acting opioids like heroin, oxycodone, methadone or suboxone – are started immediately on methadone treatment. The newborn receives the treatment first in a hospital nursery, and then on an outpatient basis in the home.
The entire time, the baby remains with the mother.
Most of the moms served by MAiN, about 75 percent, are not using illicit opioids or abusing prescription medications. They are in recovery and are being treated with either methadone or suboxone, opioids that can cause NAS in their newborns.
A recent evaluation of MAiN, which compared the model with NAS infants treated with traditional care, found no statistical difference in negative medical outcomes and that MAiN newborns had a lower percentage of emergency room visits after being released from the hospital. It is also a lot cheaper: $8,204 less per birth, according to the evaluation.
MAiN infants were involved in more reports to child protective services (CPS); 33 percent of the MAiN group, as opposed to 23 percent of the comparison. The difference landed right on the line of statistical significance used in the evaluation, and the study did not control for the diligence or quality of reporters involved.
“It could be that MAiN staff are more attentive to those types of issues as well as the fact that many of the other infants are cared for in NICUs, whereas MAiN cares for the infants by rooming in with mom,” said Julie Sumney, one of the researchers on the evaluation.
We interviewed Dr. Hudson about the present, and future, of the MAiN model.
You developed MAiN in 2003. Is this the first effort to gauge its outcomes compared with traditional approaches?
Yes, it is.
We’ve been practicing this model for over a decade. But I’m a clinician, not really a researcher. I’ve been encouraged by the state to publish outcomes related to the model we’ve been practicing.
So each MAiN infant is treated with methadone right away, stays with mom in the hospital, and is then weaned off as an outpatient, is that right?
Did the non-MAiN infants all experience the same basic course of treatment, and if so, can you describe?
There is some variability in how well hospitals identify babies at risk. If they are identified as at risk, they’re monitored in the hospital a little bit longer. But nobody is treating early outside of us.
If babies are in withdrawal, the NICU is traditionally used for medication therapy, and then the lower level nursery can handle swaddling and rocking. But for some subset of babies, that’s not enough and they end up in NICU.
They stay there the entire time in treatment. Usually that’s several weeks, and they are not allowed to wean at home.
And your view is that waiting to see if they go into withdrawal before treating with methadone is cruel to the newborns?
I think my biggest focus is on the ethics of allowing a baby to withdraw. We don’t subject adults to forced withdrawal, so I’m astonished others haven’t had the same approach.
Early treatment is no different than critical care coverage. But when it comes to babies being potentially opioid-dependent, we say, let’s let them quit cold turkey and see what happens.
Do you think the icky-ness of giving a baby methadone is part of the reason?
Yes, I think it’s fear-based. But we’ve done this before. There was a big push 20 years ago about pain: babies getting chest tubes, ventilated, etcetera, with no pain control. Because we are afraid of side effects.
The conclusion then was pain is bad for babies. There is a higher mortality rate, and worse pain experience later.
So of the newborns who are monitored for potential withdrawal, how many actually end up not going into withdrawal?
That’s the critical question nobody has been able to answer. That’s why most places are hesitant to try something new. The literature is all over the place.
Anecdotally, based on my own observations, babies exposed to long-acting opioids are at a 90 percent risk of withdrawal.
What about risks associated with early treatment in your model, is that an issue?
Yes, and that’s why it was important to study this, to see how many babies are we treating that don’t need it.
We looked at how many times we over-sedated with the treatment we provided, and if we had to cut back. [Over-sedation is identified in symptoms such as low heart rate, slow breathing or sleepiness to the point where the infant could not wake up to eat.]
Our rate of over-sedation was 4 percent. So 96 percent of our cohort benefitted from the treatment.
The cost difference between MAiN and the comparison group was more than $8,000: $10,058 versus $18,262. What is that mostly attributable to?
I was actually surprised … that the costs weren’t higher at the state level, when we look at national numbers.
The majority of the difference is the level of care. If a baby is in a NICU bed, the charge is many times more than in a well-baby bed. And on lengths of [hospital] stay, our average is eight days. In South Carolina for NAS infants, the average is 16 days, and nationally it’s 23 days.
Are child welfare workers involved in observation of MAiN infants during the hospital stay?
We don’t report every case. We are careful though, as a clinical team, to evaluate the situation, and make referrals to CPS If we have concerns. If a mother is new to treatment – was using heroin or illegal drugs and just got into treatment – we wouldn’t consider her stable if she had not completed [MAiN outpatient treatment for the newborn]. Most of those will be followed by CPS reports. And any relapse, of course, we would be concerned about.
We do have a liaison with CPS in the Greenville hospital who comes to rounds. She serves as a sounding board. So we do have special relationship with CPS, but they don’t do direct observations.
Is there interest in expanding your model in South Carolina?
Medicaid in South Carolina is funding my team to do trainings. The next phase of our project is getting out to [other] hospitals.
Medicaid pays for a lot of NAS costs. So the state interest is cost savings, but it’s also just a better model of care. It allows moms to stay with babies, and we can observe them during their hospital stay.
What, if anything, you hope to do to advocate for increased use of this model in other states?
We are talking about that now. We’re looking at NIH [National Institutes of Health] grant opportunities. There is a lot of potential funding people are talking about related to the opioid epidemic. It looks like we could be a good fit.