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Neonatal Abstinence Syndrome
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.
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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.
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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 . . .
Journal Article
Opioids and the developing brain: time to rethink perinatal care for infants of opioid-dependent mothers
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.
Journal Article
Exposure to prescription opioid analgesics in utero and risk of neonatal abstinence syndrome: population based cohort study
Objective To provide absolute and relative risk estimates of neonatal abstinence syndrome (NAS) based on duration and timing of prescription opioid use during pregnancy in the presence or absence of additional NAS risk factors of history of opioid misuse or dependence, misuse of other substances, non-opioid psychotropic drug use, and smoking.Design Observational cohort study.Setting Medicaid data from 46 US states.Participants Pregnant women filling at least one prescription for an opioid analgesic at any time during pregnancy for whom opioid exposure characteristics including duration of therapy: short term (<30 days) or long term (≥30 days); timing of use: early use (only in the first two trimesters) or late use (extending into the third trimester); and cumulative dose (in morphine equivalent milligrams) were assessed.Main outcome measure Diagnosis of NAS in liveborn infants.Results 1705 cases of NAS were identified among 290 605 pregnant women filling opioid prescriptions, corresponding to an absolute risk of 5.9 per 1000 deliveries (95% confidence interval 5.6 to 6.2). Long term opioid use during pregnancy resulted in higher absolute risk of NAS per 1000 deliveries in the presence of additional risk factors of known opioid misuse (220.2 (200.8 to 241.0)), alcohol or other drug misuse (30.8 (26.1 to 36.0)), exposure to other psychotropic medications (13.1 (10.6 to 16.1)), and smoking (6.6 (4.3 to 9.6)) than in the absence of any of these risk factors (4.2 (3.3 to 5.4)). The corresponding risk estimates for short term use were 192.0 (175.8 to 209.3), 7.0 (6.0 to 8.2), 2.0 (1.5 to 2.6), 1.5 (1.0 to 2.0), and 0.7 (0.6 to 0.8) per 1000 deliveries, respectively. In propensity score matched analyses, long term prescription opioid use compared with short term use and late use compared with early use in pregnancy demonstrated greater risk of NAS (risk ratios 2.05 (95% confidence interval 1.81 to 2.33) and 1.24 (1.12 to 1.38), respectively).Conclusions Use of prescription opioids during pregnancy is associated with a low absolute risk of NAS in the absence of additional risk factors. Long term use compared with short term use and late use compared with early use of prescription opioids are associated with increased NAS risk independent of additional risk factors.
Journal Article
Eat, Sleep, Console Approach or Usual Care for Neonatal Opioid Withdrawal
Although clinicians have traditionally used the Finnegan Neonatal Abstinence Scoring Tool to assess the severity of neonatal opioid withdrawal, a newer function-based approach - the Eat, Sleep, Console care approach - is increasing in use. Whether the new approach can safely reduce the time until infants are medically ready for discharge when it is applied broadly across diverse sites is unknown.
In this cluster-randomized, controlled trial at 26 U.S. hospitals, we enrolled infants with neonatal opioid withdrawal syndrome who had been born at 36 weeks' gestation or more. At a randomly assigned time, hospitals transitioned from usual care that used the Finnegan tool to the Eat, Sleep, Console approach. During a 3-month transition period, staff members at each hospital were trained to use the new approach. The primary outcome was the time from birth until medical readiness for discharge as defined by the trial. Composite safety outcomes that were assessed during the first 3 months of postnatal age included in-hospital safety, unscheduled health care visits, and nonaccidental trauma or death.
A total of 1305 infants were enrolled. In an intention-to-treat analysis that included 837 infants who met the trial definition for medical readiness for discharge, the number of days from birth until readiness for hospital discharge was 8.2 in the Eat, Sleep, Console group and 14.9 in the usual-care group (adjusted mean difference, 6.7 days; 95% confidence interval [CI], 4.7 to 8.8), for a rate ratio of 0.55 (95% CI, 0.46 to 0.65; P<0.001). The incidence of adverse outcomes was similar in the two groups.
As compared with usual care, use of the Eat, Sleep, Console care approach significantly decreased the number of days until infants with neonatal opioid withdrawal syndrome were medically ready for discharge, without increasing specified adverse outcomes. (Funded by the Helping End Addiction Long-term (HEAL) Initiative of the National Institutes of Health; ESC-NOW ClinicalTrials.gov number, NCT04057820.).
Journal Article
Neonatal Abstinence Syndrome In The United States, 2004–16
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.
Journal Article
Sodium oxybate – new views on an old candidate This presentation will outline the outcome of a clinical development program, including a Phase 3 study, on sodium oxybate in the treatment of alcohol dependence
Sodium oxybate (SMO) has shown efficacy in the treatment of alcohol withdrawal syndrome (AWS) and in the maintenance of abstinence in alcohol dependent (AD) patients in a series of pilot randomized controlled trials. SMO is marketed in these indications in Italy and Austria since 1991 and 1999, respectively. To expand access to SMO for the treatment of AD in other EU countries and since regulatory standards have evolved, a clinical development and research project in accordance with regulatory guidelines has been initiated in the maintenance of abstinence to further support the already available data. Phase 2 and 3 studies in AD patients were conducted. Results of this development program showed efficacy of SMO in the maintenance of abstinence in AD patients. Since heterogeneity of SMO treatment effect between studies was identified, various analyses explored the potential moderators of SMO efficacy. SMO efficacy was larger in high-severity AD population and with longer treatment duration. SMO was well tolerated both in regular clinical use and in clinical trials.Disclosure of InterestJ. Guiraud Shareolder of: Vergio, Employee of: Vergio
Journal Article
The effect of age and abstinence time on semen quality: a retrospective study
This study analyzed the effects of male age and abstinence time on semen quality and explored the best abstinence time for Chinese males among different age groups. Semen parameters, including sperm kinetics, morphology, and DNA fragmentation index (DFI), were reviewed from 2952 men. Samples were divided into six age groups (≤25 years, 26-30 years, 31-35 years, 36-40 years, 41-45 years, and >45 years) and were divided into six groups according to different abstinence time (2 days, 3 days, 4 days, 5 days, 6 days, and 7 days). The differences in semen quality between the groups were compared, and the effect of age and abstinence time on semen quality was analyzed. Significant differences were observed in semen volume, progressive motility (PR), and DFI among the age groups (all P < 0.05), and no significant differences were observed in sperm morphological parameters (all P > 0.05). There were significant differences in semen volume, PR, and DFI among different abstinence time groups (all P < 0.05) and no significant differences in sperm morphological parameters (all P > 0.05). Pearson analysis showed that male age and abstinence time were both significantly correlated with sperm kinetics and DFI (both P < 0.05), while no significant correlation was found with sperm morphological parameters (all P > 0.05). The box plots and histograms of men's age, abstinence time, and semen quality show that most semen quality parameters differ significantly between the 2 days and 7 days abstinence groups and other groups at different ages. Except for the sperm morphology parameters, sperm kinetic parameters and sperm DFI are linearly related to male age and abstinence time.
Journal Article