Revolutionizing the Treatment for Babies Withdrawing From Opioids
Yale’s Dr. Grossman challenged dogma to change the outcome for infants
This story starts with a puzzle. Can you think outside the box? If so, try solving the following challenge. Imagine this nine-dot puzzle is printed on a sheet of paper. Now, with a pen, connect all the dots, drawing just four straight lines without taking your pen off the paper.
We’ll get back to the puzzle in a moment, but first, let’s take a journey through time.
An anticipated gathering
Five years ago, I entered a San Diego convention hall 10 minutes early for a presentation yet was unable to locate a vacant seat. Physicians from across the country had gathered to hear from experts about the latest research and trends in the care of hospitalized patients. I wasn’t the only one whose interest was sparked by this particular session’s title, “Neonatal Abstinence Syndrome: Rethinking Our Approach.”
Neonatal abstinence syndrome (NAS), also called neonatal opioid withdrawal syndrome (NOWS), is a condition seen in babies born to mothers taking opioid drugs such as heroin, morphine, hydrocodone, and methadone. In utero, these drugs transfer across the placenta, cross the blood-brain barrier, and accumulate in the brain of a developing fetus. At birth, infants with NAS suffer from a host of distressing symptoms because their bodies, grown accustomed to opioids while in the womb, are suddenly cut off from a steady supply of the drug.
The burden of disease
As a result of the opioid epidemic over the past three decades, the number of newborns suffering from NAS in the United States has risen steadily. As many as 2% of babies born in the hospital go on to develop NAS, and a new case is diagnosed approximately every 15 minutes. An article published in the New England Journal of Medicine reported that from 2004 to 2013, “the total percentage of NICU days nationwide that were attributed to NAS increased from 0.6% to 4%.”
NAS contributes significantly to the financial strain of both health care systems and individuals. The yearly cost to taxpayers via public insurance was more than $400 million as of 2014. A study of 23 hospitals across the country determined that from 2013 to 2016, the average hospital stay for babies with NAS was 19 days, with each stay costing an average of $37,584 — compared to three days and $3,536, respectively, for newborns with other medical conditions.
Though not as easily measured, NAS exerts an emotional toll on infants and caretakers, particularly mothers. Opioids come in many forms, both illicit and prescription. The opioid family includes substances ranging from injectable heroin to pain medications like hydrocodone to drugs designed to treat addiction, such as methadone. A pregnant woman may find herself taking opiates for any number of reasons, and such a circumstance does not necessarily imply a lack of concern for her unborn child.
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A noisy introduction
Let’s rewind another five years to 2011. I was in my first year of residency training and rotating in the NICU. I distinctly recall hearing for the first time the high-pitched scream of a newborn suffering from NAS. Sometimes inconsolable, infants with NAS may experience a number of additional symptoms, including a heightened startle response, increased muscle tone, poor suck, uncoordinated feeding, frequent sneezing, poor sleep, increased caloric needs due to a high metabolism, diarrhea, temperature instability, and even seizures.
At that time, the standard of care across the country was to treat NAS with opioid medications — typically in the form of liquid morphine or methadone administered by mouth. The thought was that withdrawal symptoms could be reduced by replenishing the opiates babies were no longer receiving from their mothers. Over time, the pharmaceutical dose was gradually decreased until the infant was weaned off treatment entirely.
Similar to veterinary medicine, the lack of communication between infants and physicians hampers a provider’s ability to treat symptoms. Because babies can’t use words to explain how they feel, symptom-based scoring systems were devised to assess whether a case of withdrawal was worsening or improving. Neonates can exhibit a wide range of symptoms related to NAS, so these scoring tools became rather complex.
Origins of a system
Developed in 1975, the Finnegan Neonatal Abstinence Scoring System (FNASS), named after Loretta Finnegan, MD, soon became the most widely adopted method of evaluating patients with NAS. This 21-point scoring tool is what my hospital was using in 2011. Infants were assessed every three hours and assigned a score based on many factors associated with NAS, including sleep duration, presence of tremor, poor feeding, stuffy nose, yawning, sneezing, irritability, and sweating.
Standardized protocols based on Finnegan scores were developed to determine whether a baby’s methadone dose, for example, should be increased, decreased, or remain the same after each assessment. The hospital where I worked prided itself on using the latest and best protocols to improve the comfort of such infants and reduce the amount of time they needed to stay in the hospital.
Neonatal abstinence syndrome (NAS), also called neonatal opioid withdrawal syndrome (NOWS), is a condition seen in babies born to mothers taking opioid drugs such as heroin, morphine, hydrocodone, and methadone.
Despite focused efforts to streamline this protocol-driven process, it was not unusual for me to find myself caring for an infant for 20 or more days. I would receive calls in the middle of the night requesting orders to increase a baby’s methadone dose because her Finnegan score rose above a certain threshold. While on the phone with the nurse, I would often hear the infant wailing in the background. Sometimes I would realize an extra yawn or sneeze was all it took to nudge the score up and warrant a dose increase.
It was often crushing for a family to hear they wouldn’t be taking their son or daughter home for another two or three days because we had to take a step back on the weaning protocol. Like many of my colleagues, I found myself wondering if there might be a better way to care for these babies and families.
Locating the glitches
I was beginning to recognize flaws in the methodology. I noticed abrupt increases or decreases in Finnegan scores that often occurred at the time of nursing shift change. No, there was no secret alliance of rogue nurses intent on confining babies to the hospital. These sudden scoring fluctuations seemed to be the product of a subjective and operator-dependent system. After all, how easy is it to distinguish between a mild and a moderate tremor or mild and moderate excoriations (scratches)?
Another shortcoming of the FNASS was its lack of specificity. While it was true that babies with NAS were more likely to yawn, sneeze, tremble, or sweat, NAS was far from the only cause of such symptoms.
But (I told myself) I thought we were using the most up-to-date and evidence-based scoring system and weaning protocol available. After more than 35 years of refinement across multiple institutions, could such a system really be improved upon? It seemed like any effort to do so would be like rearranging deck chairs on the Titanic. Though my mind could not conceive of it at the time, the system didn’t need to be improved—it needed to be replaced.
A crucial message
Back to 2016: At the front of that packed conference hall stood Matthew Grossman, MD, a pediatric hospitalist who practices at Yale New Haven Children’s Hospital. He was accustomed to providing care for infants with NAS using methods similar to those I had been trained to use and similar to the way most of the country was treating NAS at the time. Grossman tells Elemental, “I used the traditional approach for three or four years before starting to make changes.”
For the entirety of his talk, Grossman engrossed his audience of doctors and other medical providers. Not to overdramatize, but it felt as if a long-expected prophet of medicine had arrived to deliver the common folk a message from the great baby doctor in the sky. Though none of us had derived it on our own, the message was so simple and profound that it felt like we had always known of it.
He began by asking why we were doing what we were doing. The answer, according to Grossman, was that we were likely just repeating the familiar. He used the analogy of adding more masts and sails to a boat. Eventually, the way to make the boat faster was not to add another mast or a sail—it was to change the method of propulsion altogether.
A new beginning
Grossman and his colleagues at Yale formulated the simple premise that babies need to eat, sleep, and be consoled (ESC). That was it. It didn’t matter how much they sweated or sneezed; for the most part, they simply required those three essentials, which, as it turned out, were all easily quantifiable. Grossman’s medical team monitored the infants in their hospital with NAS and evaluated if they were able to take a one-ounce feed (or breastfeeding equivalent), sleep for an hour, or be consoled within 10 minutes. Pharmaceutical agents were administered only if these essential needs could not be met.
In addition to modifying the way infants with NAS were assessed, the ESC model changed how they were treated. Instead of placing babies on slow, scheduled opiate weans, single doses of morphine were given on an as-needed basis. As a result, requiring a dose of morphine no longer implied backtracking on a weaning protocol and another two to three days in the hospital.
Babies were no longer separated from their families. Instead of being treated in the NICU, they were kept on the mother-baby unit. Instead of starting with pharmaceuticals, the mother, or another caretaker, became the first line of treatment. Breastfeeding, skin-to-skin placement, swaddling, darkening the room, and limiting stimulation became the norm. Babies were fed ad lib rather than on a strict three-hour schedule. Grossman’s team brought back many of the naturally comforting things we tend to do for infants that weren’t available to babies with NAS in the NICU setting.
Grossman then presented his results, which were no less than astounding. By implementing the ESC model over the course of two years, the average length of stay for 287 patients with NAS had decreased from 22 to 6 days. Morphine use plummeted from 98% to 14%, and the average cost of care decreased from $44,824 to $10,289. No adverse events were identified.
Spreading the news
Arriving home from the conference, I was excited to start using ESC at my own hospital in Montana. Fortunately, I didn’t have to wait long. A colleague, neonatologist Allison Rentz, MD, had also become aware of ESC. Thanks to her leadership, our hospital became an early adopter the following year. Rentz describes her initial impression of Grossman’s work: “The dramatic response that he saw in reducing length of stay, reducing need for morphine, reducing need for ICU care — everywhere that people had started using it, it was positive. No negatives.”
Like many other hospitals, our facility incorporates a volunteer cuddler program for babies with NAS who lack available family members to hold and console them. Although the program is now on pause during the Covid-19 pandemic, prior to Covid, demand was so high that more than 400 people had applied for only 30 available positions.
ESC has continued to spread rapidly to hospitals across the country. The Yale group’s protocol was reproduced in a similar fashion by a group at Boston Medical Center, who then developed a tool kit that was shared with the Colorado Perinatal Care Quality Collaborative and subsequently with us. Rentz recalls, “I had teaching modules for the nurses. We had education materials. We had templates for what we would give to parents. It kind of fell in our lap. [A new protocol] usually would take a long time to get to a small state like this.”
Until we shifted to ESC, improvement processes at our hospital had allowed us to reduce the average length of stay for NAS patients to about 12 days (which was considered satisfactory for an institution utilizing the FNASS). Implementing ESC changed the game entirely: According to Rentz, the length of stay dropped to four to five days.
Other institutions have seen similar results with ESC. Boston Medical Center saw a 35% decrease in length of stay and a 54% reduction in pharmacologic treatment, while the University of North Carolina’s health system experienced a 52% reduction in length of stay and a 79% decrease in pharmacotherapy. ESC principles have now been implemented in at least 25 states, and the number continues to grow.
The development and spread of ESC would not have occurred without the approach to problem-solving advocated by Dr. Grossman. Remember the dot puzzle above? As you can see below, solving it does indeed require one to think outside the box. In fact, as Grossman described in a 2019 article published in Hospital Pediatrics, it actually requires one to realize there is no box at all.
Just like in the puzzle, as providers managing infants with NAS, we had inadvertently boxed ourselves in. We were doing what we were doing because everyone else was doing it — and it was what had always been done. Eventually, someone would discover the box was an unnecessary construct. After arriving at this conclusion, Grossman went on to consider how this concept applied to other areas of pediatric medicine.
He explains, “There are boxes everywhere in medicine. I think one area is neonatal jaundice. All babies have elevated bilirubin levels compared to adults and levels are increased by breastfeeding.” Grossman suggests this problem should be viewed more often as a normal process and highlighted the lack of evidence behind the thresholds pediatricians use to decide if an infant with jaundice needs to receive phototherapy with ultraviolet light. Grossman adds, “It is important to treat pathologic hyperbilirubinemia [jaundice] but we have medicalized a normal process.”
I asked Rentz the same question. She was quick to identify a box around the topic of nasogastric (NG) feedings. Some infants, particularly if born prematurely, have yet to develop the ability to suck and swallow milk from a bottle or breast. This is called dysphagia and, in the case of preemies, typically resolves as they approach their original due date. Oftentimes, infants in the NICU require the placement of an NG tube to provide adequate nutrition.
Rentz explains, “There’s a lot of movement around the country right now to develop home NG programs, so parents could be taught to feed their kids with an NG at home.” Rentz describes how with the proper training, caretakers might safely and effectively provide NG feeds for infants at home, thereby reducing the amount of time they need to remain in the hospital.
Physicians swear an oath stating that, to the best of their ability, they will do no harm to their patients. In many cases, particularly when considering the youngest patients, doctors appropriately err on the side of safety and caution in an effort to reduce the risk of harm. It is my hope that as science progresses, it will become increasingly clear when conditions like NAS, neonatal jaundice, or dysphagia require aggressive medical interventions and when nature can run its course with minimal intrusion from unwieldy boxes.