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Background Opioid use and misuse during pregnancy rose from 1.5 to 6.5 per 1000 deliveries between 1999 and 2014 and continues as a significant public health concern. A fivefold increase in neonatal opioid withdrawal syndrome (NOWS) has accompanied the increase in opioid use. The Eating, Sleeping, Consoling care approach (ESC) has been shown to improve outcomes for infants with NOWS and is quickly becoming the standard of care for infants affected by opioid use disorder. Quality improvement initiatives following the implementation of ESC provide some evidence to suggest that symptom-based (i.e., as needed, PRN, just in time) dosing of opioid medications for infants with significant withdrawal may be an effective alternative to using a traditional scheduled opioid taper approach. These initiatives have shown reduced length of hospital stay and decreased postnatal opioid exposure when compared to scheduled opioid dosing for infants with NOWS who receive pharmacologic treatment. It is unknown if the findings from these quality improvement initiatives are generalizable, and little is known about the safety of this approach in a diverse population. The purpose of this manuscript is to describe the design and rationale for an ongoing study to evaluate the effect of symptom-based opioid dosing compared to traditional scheduled opioid taper on short-term outcomes for infants with NOWS. Methods/design In this ongoing multi-center two-period cluster crossover randomized controlled trial, 24 sites within the USA were randomized at the site level into one of two sequences. Prior to randomization, sites were stratified by care approach used (ESC vs. usual care) and these strata were independently randomized. All study sites will provide care based on their random allocation. Data will be collected under waiver of consent for in-hospital and short-term outcomes for eligible infants. A minimum of 480 infants will be enrolled. We hypothesize that use of symptom-based dosing will safely reduce the length of time until infants with NOWS and at risk for pharmacological treatment are medically ready for discharge when compared to infants treated with a scheduled opioid taper. Discussion This trial is uniquely and efficiently designed to establish the efficacy, safety, and generalizability of the symptom-based dosing approach to opioid treatment for NOWS. Trial registration NCT05980260 ; registered July 27, 2023.

Objective To assess implicit bias by administrating the Modified Finnegan Score (MFS) for quantifying neonatal opioid withdrawal and to evaluate risk of decreased opioid treatment of Black versus White infants. Study Design Study participants were nurses recruited from a large tertiary care center who received three clinical vignettes portraying withdrawing infants and were randomized to receive an accompanying photo of either a Black or White infant. MFS results were compared for identical vignettes based on race of infant photo. Results Out of 275 nurses, 70 completed the survey. In vignette 2, nurses aged ≤35 years scored Black infants lower than White infants (MFS=8.3 ± 2 vs. 9.5 ± 1.2, p =0.012). Nurses with <5 years of experience and ≤10 years of experience also scored Black infants lower for the same vignette (8.2 ± 2.3 vs. 9.6 ± 1.2, p =0.032 and 8.3 ± 2 vs. 9.5 ± 1.2, p =0.0083). Conclusion Implicit bias may contribute to the difference in opioid treatment.

Infants born to mothers who take opioids may have symptoms of opioid withdrawal after birth. Early detection and holistic treatment that incorporates pharmacologic and nonpharmacologic interventions can help improve outcomes for affected infants. The neonatal abstinence syndrome was first described in the literature in the 1970s by Dr. Loretta Finnegan. 1 Although this syndrome has been recognized for more than four decades, there have been substantial changes in the past 10 years, including a dramatic increase in prevalence and changes in both the exposure substance and clinical management. 2 , 3 There has also been a considerable amount of research on the neonatal abstinence syndrome, and effective management strategies have been developed. However, gaps still exist, including a lack of clarity and consistency in how the syndrome is defined, measured, and managed. In addition, much of . . .

After increasing for nearly two decades, rates of neonatal abstinence syndrome have recently leveled off, reaching a plateau as early as 2014. These findings may represent successful efforts to prevent and treat opioid use before and during pregnancy.Newborns exposed to opioids in utero are at risk for developing neonatal abstinence syndrome (NAS), a drug withdrawal syndrome characterized by irritability, increased muscle tone, tremors, poor feeding, and respiratory difficulties. The increasing prevalence of opioid use disorder among reproductive-age women during 2004-16 resulted in a five-and-a-half-fold increase in NAS rates (exhibit 1).1,2 Recent provisional data from the Centers for Disease Control and Prevention suggest that rates of opioid-related overdose deaths have plateaued.3 However, there are no recent data on national rates of NAS. Using data from a national all-payer inpatient sample, we examined overall NAS trends and incidence patterns across US census regions during 2004-16.

Illicit use of opioids is a global health crisis with major implications for women and children. Strategies for managing opioid use disorder (OUD) in pregnancy have been tested over the past 40 years, but studies have focused on maternal and pregnancy outcomes, with less attention given to long-term follow-up of exposed children. Here, we provide a narrative review of recent advances in the assessment and management of neonatal opioid withdrawal syndrome (NOWS), and we summarise evidence from multiple domains—neuroimaging, electrophysiology, visual development and function, neurodevelopment, behaviour, cognition and education—which suggests that prenatal opioid exposure modifies child development. Further studies are required to determine the optimal management of pregnant women with OUD and babies with NOWS. We identify knowledge gaps and suggest that future study designs should evaluate childhood outcomes, including infant brain development and long-term neurocognitive and visual function.

IntroductionEstimating Neonatal Abstinence Syndrome (NAS) and prenatal substance exposure rates in Medicaid can help target program efforts to improve access to services.MethodsThe data for this study was extracted from the 2016–2020 Transformed Medicaid Statistical Information System (T-MSIS) Analytic Files (TAF) Research Identifiable Files (RIF) and included infants born between January 1, 2016 and December 31, 2020 with a either a NAS diagnosis or prenatal substance exposure.ResultsBetween 2016 and 2020, the estimated national rate of NAS experienced a 18% decline, while the estimated national rate of prenatal substance exposure experienced a 3.6% increase. At the state level in 2020, the NAS rate ranged from 3.2 per 1000 births (Hawaii) to 68.0 per 1000 births (West Virginia). Between 2016 and 2020, 28 states experienced a decline in NAS births and 20 states had an increase in NAS rates. In 2020, the lowest prenatal substance exposure rate was observed in New Jersey (9.9 per 1000 births) and the highest in West Virginia (88.1 per 1000 births). Between 2016 and 2020, 38 states experienced an increase in the rate of prenatal substance exposure and 10 states experienced a decline.DiscussionEstimated rate of NAS has declined nationally, but rate of prenatal substance exposure has increased, with considerable state-level variation. The reported increase in prenatal substance exposure in the majority of US states (38) suggest that substances other than opioids are influencing this trend. Medicaid-led initiatives can be used to identify women with substance use and connect them to services.SignificanceWhat is already known about the topic? Neonatal Abstinence Syndrome (NAS) and prenatal substance exposure are significant risk factors for poor neurodevelopmental and mental health outcomes in early childhood. NAS birth rates have been increasing in the US since 2000 and the majority of NAS births are covered by Medicaid.What this article adds? This article estimates national and state-level prenatal substance exposure and NAS rates among Medicaid-covered infants born between 2016-2020 using data from the Transformed Medicaid Statistical Information System. This is the first study using post-2017 data to estimate national NAS rates. The findings can inform future federal and state policy efforts to improve access to screening, diagnosis and treatment among pregnant women with substance use disorder and infants with NAS.

ImportanceVigilant clinical assessment is the key to preventing complications, including death, in infants at risk of neonatal withdrawal syndrome. The eat, sleep and console (ESC) is proposed as an alternative to usual care with Finnegan’s Neonatal Abstinence Scoring System (FNASS), but whether ESC improves infant outcomes is uncertain.ObjectiveTo conduct a meta-analysis and systematic review of outcomes of studies comparing ESC to FNASS.Data sourcesPubMed, Embase, CINAHL and Cochrane were searched. There was no date restriction.Study selectionPublished data from observational studies published in English were included. Randomised controlled trials, reviews and abstracts were excluded. Data was required to be converted to mean and SD to be included.Data extraction and synthesisPreferred Reporting Items for Systematic reviews and Meta-Analyses guidelines were used, and data were independently extracted by multiple observers. Data was pooled using a random-effects model.Main outcome and measuresLength of stay (LOS) in days, number of days medicated and proportion of infants medicated were the primary outcomes assessed. It was hypothesised prior to data collection that ESC would be associated with shorter LOS and a lower proportion of infants medicated, given key differences in infant assessment compared with the FNASS.Results12 studies, all from the USA, were published between 2018 and 2024. 10 quality improvement studies and two cohort studies compared ESC (n=1877) with historical controls using FNASS (n=2199). ESC decreased hospitalisation days (MD −4.11 days, 95% CI −6.04 to −2.19 days; p<0.0001; I2=95%; 10 studies; 3703 participants) and the proportion treated with withdrawal medications (OR 0.36, 95% CI 0.22 to 0.60; I2=89%; RD −0.22; 95% CI −0.34 to −0.10; p<0.0001; I2=93%; 12 studies; 4076 participants). One study assessed physical health up to 1 week after discharge (n=1), three assessed weight loss (n=3) and one assessed cost (n=1).Conclusions and relevanceThe majority of evidence for a reduction in hospitalisation and need for withdrawal medication with ESC compared with FNASS is derived from quality improvement and cohort studies with almost no health information beyond 1 week after discharge. High-quality trials incorporating physiological measurements of infant stress and longer-term outcomes are needed.Review prospective registrationCRD42024532169.

Prenatal opioid exposure (POE) is commonly associated with neonatal opioid withdrawal syndrome (NOWS), which is characterized by a broad variability in symptoms and severity. Currently there are no diagnostic tools to reliably predict which infants will develop severe NOWS, while risk stratification would allow for proactive decisions about appropriate clinical monitoring and interventions. The aim of this prospective cohort study was to assess if extracellular microRNAs (miRNAs) in umbilical cord plasma of infants with POE could predict NOWS severity. Participants (n = 58) consisted of pregnant women receiving medications for opioid use disorder and their infants. NOWS severity was operationalized as the need for pharmacologic treatment and prolonged hospitalization (≥ 14 days). Cord blood miRNAs were assessed using semi-quantitative qRT-PCR arrays. Receiver operating characteristic curves and area under the curve (AUC) were estimated. The expression of three miRNAs (miR-128-3p, miR-30c-5p, miR-421) predicted need for pharmacologic treatment (AUC: 0.85) and prolonged hospitalization (AUC: 0.90). Predictive validity improved after two miRNAs (let-7d-5p, miR-584-5p) were added to the need for pharmacologic treatment model (AUC: 0.94) and another two miRNAs (let-7b-5p, miR-10-5p) to the prolonged hospitalization model (AUC: 0.99). Infant cord blood extracellular miRNAs can proactively identify opioid-exposed neonates at high-risk for developing severe NOWS.

Neonatal abstinence syndrome (NAS) results from discontinuation of in utero exposures to opioids/substances. The rising incidence of NAS has prompted an increased need for accurate research and public health data. To examine how NAS has been defined in clinical studies of opioid-exposed mothers and infants, a review process was developed based on the RAND/UCLA Appropriateness Method, yielding 888 abstracts. Per inclusion criteria, 57 abstracts underwent full-text review. To define NAS, studies cited using modified versions of the Finnegan NAS scoring tool (n = 21; 37%), ICD-9/10 coding (n = 17; 30%), original Finnegan tool (n = 16; 28%), Eat Sleep Console (n = 3; 5%), and Lipsitz (n = 3; 5%) tools, (3 cited 2+ tools). Most studies utilized subjective NAS scoring/assessment algorithms and neonatal coding as key elements defining NAS. While most cited opioid exposure as integral to their inclusion criteria, 26% did not. These approaches highlight the need for a more refined and standardized definition of NAS.

Background The aim of this study was to investigate the association between race and severe neonatal opioid withdrawal syndrome (NOWS) in infants exposed to intrauterine opioids. Methods This is a prospective observational study on intrauterine opioid-exposed term infants. Exposure to opioids was based on maternal disclosure, urine, or umbilical cord drug screening. Severe NOWS was defined based on modified Finnegan scoring and the need for pharmacological intervention. Results One hundred and fifty mother–infant pairs, 60 Black and 90 White with history of opioid exposure during pregnancy, were included. More White than Black infants developed NOWS that required pharmacological treatment, 70 vs. 40%: RR = 1.75 (1.25–2.45). In adjusted analysis, there was no significant association between race and the development of severe NOWS in mothers who attended opioid maintenance treatment program (OMTP). However, in mothers who did not attend OMTP, White race remained a significant factor associated with the development of severe NAS, RR = 1.69 (1.06, 2.69). Conclusions Severe NOWS that required pharmacological intervention was significantly higher in White than in Black infants born to mothers who did not attend OMTP. Larger studies are needed to evaluate the association between social as well as genetic factors and the development of NOWS. Impact There is a significant association between race and development of severe NOWS.