Researchers test simplified assessment for neonates with opioid exposure

Researchers have shortened the assessment tool used to determine pharmacologic treatment options for newborns exposed to opioids in the womb and say the changes could help increase the tool’s clinical utility.

In a study published on April 8, 2020, on JAMA Network Open, researchers investigated whether the Finnegan Neonatal Abstinence Scoring Tool (FNAST), used to gauge signs of opioid exposure and withdrawal at birth, could be simplified.¹

According to the report, both medical and nonmedical opioid use has increased significantly, from 1.5 per 1000 live births in 1999 to 6.5 per 1000 live births in 2014. Exposure to opioids in the womb, from mothers with Opioid Use Disorder (OUD), resulted in a five-fold increase in babies born with problems from opioid exposure. These problems, labeled neonatal abstinence syndrome (NAS), are rooted in the passive maternal transfer of opioids during pregnancy, followed by withdrawal symptoms at birth when that transfer ends. It can be difficult to assess, and therefore treat, neonatal withdrawal as these infants can’t communicate their symptoms, and there is a wide variation in expressions of these symptoms.

“Every neonate exposed to opioids in utero is somewhere along the continuum of withdrawal,” the report notes. “Although some neonates have mild signs and normal physiologic functions, others have more severe NAS that requires pharmacologic treatment to avoid major complications. Differences in the expression of NAS are associated with many factors, including the type of opioid exposure, co-exposure with other illicit drugs and/or psychotropic medications, genetic and epigenetic variability, the gestational age and sex of the neonate, breastfeeding, and parental engagement.”

For decades, observational assessments have been used to determine the severity of NAS and guide treatments with pharmacologic therapy. These observations are subjective, however, and variations between how different clinicians rate symptoms have been shown to result in significant differences in the initiation and duration of medications for NAS, the length of time required in the hospital, and health care utilization rates.

The FNAST is the most commonly used test for assessing infants with NAS. However, this 21-item assessment has some sections with 2 to 4 subcategories each, plus multiple scoring tools for those subcategories. Although complex and lengthy, the FNAST has shown reliability among various observers despite differences in observations. Several attempts have been made to condense the FNAST, but there have been limited data on the success of those attempts.

The goal of this study was to make the FNAST shorter and simpler by only focusing on withdrawal symptoms that required timely clinical intervention. The study team developed a set of questions to test their simplified FNAST, trialing the new tool in a cohort of 424 neonates born with opioid exposure. The infants in the study had a gestational age of at least 36 weeks and were followed from birth to hospital discharge. The team found that the simplified tool worked nearly as well as the original FNAST at discriminating between infants who did and did not receive treatment.

Lead study author Lori Devlin, DO, MHA, FAAP, associate professor of Pediatrics and director of the Neonatal Fellowship Program at the University of Louisville School of Medicine in Kentucky says the simplified FNAST focuses on 8 measures instead of 21, highlighting those that highly correlate with the receipt of pharmacologic therapy.

“These items are dichotomized-present or absent-and able to discriminate between infants who receive pharmacologic therapy and those who do not almost as effectively as the original FNAST,” Devlin says. “This shorter and dichotomized assessment tool could simplify clinical assessment by focusing on components of the original FNAST that are relatively consistent across multiple sites. After prospective validation of the tool, it could be widely used and standardize the approach to neonates with NAS.”

Specific changes that were made to the FNAST were the removal of convulsions, a high-pitched cry, and a hyperactive Moro reflex from the assessment. Convulsions were not observed in the study group, and the other 2 symptoms were determined to be too variable in nature across the study group to be well-assessed. Two items dealing with tremors were combined into 1, and only 8 of the remaining 17 test items were independently associated with pharmacologic treatment,.

The study team concluded that pharmacologic treatment for NAS may be able to be determined using just 8 criteria from the FNAST. Condensing this tool could allow for a more streamlined assessment of when a neonate needs pharmacologic therapy for NAS and enhance the clinical utility of the FNAST.

“The goal of our research was to determine if a simplified Finnegan Scoring Tool could discriminate the receipt of pharmacologic therapy as effectively as the original FNAST,” Devlin says.

As to whether Devlin and her team are advocating a change in clinical practice, she says it may be too soon to say.

“Our research focused specifically on the development of a simplified tool to assess for NAS,” she says. “We are not proposing changes in intervention or treatment protocols, as prospective clinical studies are needed to answer to such questions.”

A commentary that accompanied the study was in agreement, noting that there just isn’t enough data on the long-term effects of NAS and its treatments.² Acknowledging the benefits of a shortened tool and the efforts of Devlin’s team, the commentators questioned whether limiting assessment categories could result in missing rare and complicated expressions of NAS.

“The simplicity of this tool is attractive. However, before it can be embraced in clinical care, several questions remain to be answered,” wrote Ju Lee Oei, MD, of the University of New South Wales in Kensington, Australia, and Trecia Wouldes, PhD, of the University of Auckland, New Zealand.

Only one score was used to determine treatment, they note, and withdrawal systems change with time. This could lead to missed observations, and consistency over time is key to a proper assessment.

“The rare or uncommon items, such as seizures, were removed, but this may have limited the ability of the scale to detect severe but rare manifestations of withdrawal that require urgent treatment rather than continued observation,” the commentary notes.

Where the commentators did agree, without a doubt, was with the researchers’ call for more study on NAS and assessment tools such as the FNAST. Devlin says her team is already working on additional studies of their simplified tool.

“We hope that a standard approach using this simplified clinical tool will facilitate identifying high-risk neonates who require pharmacologic therapy for NAS,” Devlin says. “The next step is prospective studies to validate our findings. Such studies are currently under development.”

References:

1. Devlin LA, Breeze JL, Terrin N, et al. Association of a simplified Finnegan Neonatal Abstinence Scoring Tool with the need for pharmacologic treatment for neonatal abstinence syndrome. JAMA Netw Open. 2020;3(4):e202275. doi:10.1001/jamanetworkopen.2020.2275

2. Oei JL, Wouldes T. Will simplifying the Finnegan Neonatal Abstinence Scoring Tool improve outcomes for infants with opioid exposure? JAMA Netw Open. 2020;3(4):e202271. doi:10.1001/jamanetworkopen.2020.2271