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Although prescription of buprenorphine/naloxone during pregnancy is gaining acceptance, buprenorphine monotherapy is more often used due to the scarce knowledge of the effects of the combined medications on the fetus and neonate. Evaluation of neurobehavioral functioning of neonates prenatally exposed to buprenorphine/naloxone is lacking. The NICU Network Neurobehavioral Scale (NNNS) has been used to evaluate neurobehavioral functioning, stress responses, and regulatory capacities of neonates at risk for altered development due to prenatal stressors. This pilot study presents a descriptive analysis of the neurobehavioral functioning among neonates exposed in utero to buprenorphine/naloxone, as well as maternal characteristics and factors present during their pregnancy. Participants were pregnant parents receiving comprehensive treatment for opioid use disorder (OUD) and obstetric care, choosing buprenorphine/naloxone treatment with singleton, uncomplicated pregnancies. Participants provided confidential urine specimens for legal and illegal psychoactive substances according to protocol. Maternal psychiatric disorders and psychiatric medications as well as weekly dosing records were obtained for the duration of study participation. The NNNS was administered to 16 full-term neonates on days 3,14 and 30 of life. Mean summary scores for 12 neurobehavioral domains (attention, arousal, self-regulation, handling, quality of movement, excitability, lethargy, non-optimal reflexes, asymmetrical reflexes, hypertonia, hypotonia and stress/abstinence syndrome) are presented for neonates prenatally exposed to buprenorphine/naloxone at three time points during the first month of life. Several maternal factors that can influence the functioning of the neonate were presented in this sample including smoking cigarettes (94 %), a psychiatric diagnosis (87.5 %), positive urinalysis for legal or illegal substances during treatment (56.2 %). This report provides preliminary information regarding the neurobehavioral functioning of neonates exposed to buprenorphine/naloxone over the first month of life, including consideration of maternal factors. However, future research with a larger sample and controlling for different neonate and maternal factors is necessary to confirm these preliminary findings. • This is a descriptive analysis of the neurobehavioral functioning of neonates prenatally exposed to buprenorphine/naloxone. • In this preliminary study, maternal factors that may contribute to the functioning of the neonate are described. The majority of pregnant persons smoked cigarettes, had a psychiatric diagnosis, and had a positive urinalysis for legal or illegal substances during treatment. • Suggestions for future research are given to conduct inferential (including causal) analyses with a larger sample drawn from this population. [ABSTRACT FROM AUTHOR]

Buprenorphine-naloxone treatment may confer substantial benefits for the treatment of opioid use disorder (OUD) during pregnancy including lower risk for overdose/death, less diversion potential and reduced use of other substances. Treatment may also result in less severe Neonatal Abstinence Syndrome (NAS), but little is known about the effects of this medication on fetal neurodevelopment. The purpose of the current study is to evaluate neurobehaviors among fetuses exposed to buprenorphine-naloxone at four time points over the second and third trimesters of gestation in pregnant women with OUD on buprenorphine-naloxone therapy. Sixty minutes of continuous fetal monitoring via fetal actocardiograph with a single wide array abdominal transducer took place at times of peak and trough buprenorphine-naloxone levels in 24 pregnant women. Data collection, which included measures of fetal heart rate and motor activity, was conducted between 24 and 36 weeks gestation, with the majority (84.6%) monitored at two or more gestational ages. Medication dose and other substance use was monitored throughout the study and infant NAS severity was assessed. Fetal heart rate (FHR), FHR variability, accelerations in FHR, and motor activity were suppressed when buprenorphine-naloxone levels were at pharmacologic peak as compared to trough concentrations at 36 weeks, but not earlier in gestation. Maternal medication dose was unrelated to infant NAS severity. Conclusions: There were evident subclinical fetal neurophysiological responses at times of peak maternal buprenorphine/naloxone levels in later gestation, similar to those previously described for buprenorphine only. Further studies evaluating the effects of these changes in fetal neurobehaviors on the longer-term infant development are needed. • Buprenorphine-naloxone is increasingly used for the treatment of OUD in pregnancy. • Little is known about the effects of buprenorphine-naloxone on the developing fetus. • FHR parameters were lower at peak vs trough medication levels in later gestation. • FM was also depressed in later gestation at peak vs trough medication levels. [ABSTRACT FROM AUTHOR]

Aims: Assessments of effects of prenatal opioid exposure on the neonate have consisted principally of evaluations of neonatal abstinence syndrome (NAS) to determine the need for pharmacotherapy. The purpose of this study was to comprehensively evaluate the effects of gestational maternal buprenorphine maintenance on newborn neurobehavioral functioning.Study Design: Maternal substance use history and psychosocial demographics that can contribute to the neurobehavioral functioning of the infant were explored. Infants were assessed using the NICU Network Neurobehavioral Scale (NNNS) to measure their neurologic and behavioral functioning and signs of stress/abstinence on days 3, 14 and 30 of life.Subjects: Participants were 41 pregnant buprenorphine-maintained women and their infants.Results: Maternal buprenorphine dose at delivery was negatively correlated with infant quality of movement and self-regulation, and positively correlated with the central nervous system parameters of stress/abstinence at day 3 of life. As maternal buprenorphine dose increased, the mean morphine dose that the infant required for NAS treatment significantly increased. No differences were found when comparing the NNNS domain scores between infants who required pharmacotherapy for NAS versus those who did not at day 3 of life.Conclusions: Buprenorphine exposure during pregnancy can alter neonatal neurobehavioral and physiological responses to stimuli. A systematic evaluation of the newborn's functional domains above NAS assessment alone is crucial to address the challenges created by neurobehavioral dysregulation associated with substance exposure, improve caregiver/infant interaction and developmental trajectory. Comprehensive pre/postnatal treatment of buprenorphine-maintained mothers can lead to healthier outcomes for the dyad. [ABSTRACT FROM AUTHOR]

Background: Pregnancy is a unique opportunity to provide broad and necessary medical care for women- including treatment for Substance Use Disorders (SUD). The standard of care for SUD in pregnant women is treatment at a comprehensive care facility. There is little existing qualitative research exploring what brings pregnant women with SUD to treatment and what barriers to treatment exist for this population. This study explored women's self-reported reasons for pursuing treatment or hesitating to do so.Methods: This qualitative study used interviews to explore common factors that motivate pregnant women with SUD to seek comprehensive care during pregnancy and common hesitations/ barriers to treatment. The study population included 20 women in treatment at a comprehensive care facility for pregnant and parenting women at Johns Hopkins. Participants volunteered to do interviews which were recorded and transcribed for analysis.Results: Interviews revealed several major themes in motivators to seek treatment: readiness to stop using, concern for the baby's health, concern about custody of the baby or other children, wanting to escape violent environments or homelessness, and seeking structure. Barriers to treatment included fear of loss of custody, not wanting to be away from children/partner, concern about stigma or privacy, and lack of childcare and transportation.Conclusions: This study revealed common motivators to seek treatment and barriers to treatment for pregnant women with SUD. These themes may help direct future studies and guide efforts to increase access to crucial care in this vulnerable population. [ABSTRACT FROM AUTHOR]

Background: Gestational opioid use/misuse is escalating in the United States; however, little is understood about the fetal effects of medications used to treat maternal opioid use disorders.Objective: The purpose of this study was to determine the effect of maternal buprenorphine administration on longitudinal fetal neurobehavioral development.Study Design: Forty-nine buprenorphine-maintained women who attended a substance use disorder treatment facility with generally uncomplicated pregnancies underwent fetal monitoring for 60 minutes at times of trough and peak maternal buprenorphine levels. Data were collected at 24, 28, 32, and 36 weeks gestation. Fetal neurobehavioral indicators (ie, heart rate, motor activity, and their integration [fetal movement-fetal heart rate coupling]) were collected via an actocardiograph, digitized and quantified. Longitudinal data analysis relied on hierarchic linear modeling.Results: Fetal heart rate, heart rate variability, and heart rate accelerations were significantly reduced at peak vs trough maternal buprenorphine levels. Effects were significant either by or after 28 weeks gestation and tended to intensify with advancing gestation. Fetal motor activity and fetal movement-fetal heart rate coupling were depressed from peak to trough at 36 weeks gestation. Polysubstance exposure did not significantly affect fetal neurobehavioral parameters, with the exception that fetuses of heavier smokers moved significantly less than those of lighter smokers at 36 weeks gestation. By the end of gestation, higher maternal buprenorphine dose was related to depression of baseline fetal cardiac measures at trough.Conclusion: Maternal buprenorphine administration has acute suppressive effects on fetal heart rate and movement, and the magnitude of these effects increases as gestation progresses. Higher dose (≥13 mg) appears to exert greater depressive effects on measures of fetal heart rate and variability. These findings should be balanced against comparisons to gestational methadone effects, relatively good outcomes of buprenorphine-exposed infants, and recognition of the benefits of medication-assisted treatment for pregnant women with opioid use disorders in optimizing pregnancy outcomes. [ABSTRACT FROM AUTHOR]

Background: Buprenorphine, used for opioid use disorder (OUD) treatment during pregnancy, provides unknown effects on maternal physiological activity. The primary aim of this report is to document acute effects of buprenorphine administration on indicators of maternal autonomic functioning. Effects of maternal buprenorphine dose and other substance exposures on maternal measures were examined, as were neonatal abstinence syndrome (NAS) outcomes.Methods: Forty-nine pregnant, buprenorphine-maintained women yielded maternal physiologic information (heart rate and variability, electrodermal activity, and respiratory rate) at 24, 28, 32 and 36 weeks gestation. Monitoring at trough and peak maternal medication levels was implemented to ascertain acute physiologic effects of buprenorphine administration.Results: Buprenorphine administration accelerated maternal heart rate and reduced variability at two gestational ages (24 and 36 weeks) and suppressed sympathetic (electrodermal) activation at 24, 28 and 32 weeks at times of peak maternal medication levels. Maternal autonomic parameters were unrelated to polysubstance exposure with the exception of cigarette smoking. Heavier smoking dampened maternal heart rate variability across gestation and potentiated reactivity to buprenorphine at 24 and 36 weeks. Heavier smoking was also associated with reduced electrodermal activity at 36 weeks. Buprenorphine dose was unrelated to observed effects. Larger degree of maternal heart rate reactivity to buprenorphine administration was related to more severe NAS expression.Conclusions: These findings detail the maternal autonomic response to buprenorphine administration but also illustrate the significant effect of concurrent cigarette use on maternal autonomic regulation. This suggests the importance of smoking-reduction strategies in the comprehensive, medication-assisted treatment of women with OUD. [ABSTRACT FROM AUTHOR]

Background and Objectives: Maternal buprenorphine maintenance predisposes the infant to exhibit neonatal abstinence syndrome (NAS), but there is insufficient published information regarding the nature of NAS and factors that contribute to its severity in buprenorphine-exposed infants.Methods: The present study evaluated forty-one infants of buprenorphine-maintained women in comprehensive substance use disorder treatment who participated in an open-label study examining the effects of maternal buprenorphine maintenance on infant outcomes. Modifiers of the infant outcomes, including maternal treatment and substance use disorder parameters, were also evaluated.Results: Fifty-nine percent of offspring exhibited NAS that required pharmacologic management. Both maternal buprenorphine dose as well as prenatal polysubstance exposure to illicit substance use/licit substance misuse were independently associated with NAS expression. Polysubstance exposure was associated with more severe NAS expression after controlling for the effects of buprenorphine dose. Other exposures, including cigarette smoking and SRI use, were not related to outcomes. Maternal buprenorphine dose was positively associated with lower birth weight and length.Conclusions: Polysubstance exposure was the most potent predictor of NAS severity in this sample of buprenorphine-exposed neonates. This finding suggests the need for interventions that reduce maternal polysubstance use during medication assisted treatment for opioid use disorder, and highlights the necessity of a comprehensive approach, beyond buprenorphine treatment alone, for the optimal care for pregnant women with opioid use disorders. [ABSTRACT FROM AUTHOR]