Comparison of the effect of phenobarbital & levetiracetam in the treatment of neonatal abstinence syndrome (NAS) as adjuvant treatment in neonates admitted to the neonatal intensive care unit: a randomized clinical trial
Ontology highlight
ABSTRACT:
SUBMITTER: Jamali Z
PROVIDER: S-EPMC10996075 | biostudies-literature | 2024 Jan
REPOSITORIES: biostudies-literature
Similar Datasets
Project description:Neonatal Abstinence Syndrome (NAS) is a public health problem of epidemic proportions. The Finnegan Neonatal Abstinence Scoring System (FNASS) is the tool most widely used to evaluate NAS. However, it is limited by its lack of interrater reliability and standardized approach. Surveys to evaluate the FNASS were distributed to nurses at the Women and Infants Hospital in Providence, RI, USA. Infants (n = 78) treated for NAS and born to methadone-maintained mothers were examined to compare items administered from the FNASS and the NICU Network Neurobehavioral Scale (NNNS). All nurses reported that the FNASS was somewhat to very subjective. More than half reported that it was somewhat to not accurate and a new scoring method is needed to accurately diagnose NAS. Correlations between FNASS items and NNNS items showed 9 of 32 (28.1%) correlations were strong (rs > 0.5), 5 of 32 (15.6%) were moderate (0.3 < rs < 0.5), and 10 of 32 (31.3%) were weak (0.1 < rs < 0.3). Principal component factor analysis (PCA) of the NNNS explained more variance (35.1%) than PCA of NNNS and FNASS items combined (33.1%). The nursing survey supported the need for developing a more objective exam to assess NAS. NNNS exam items may be used to improve the evaluation of NAS.
| S-EPMC8394483 | biostudies-literature
Project description:There are no US Food and Drug Administration-approved therapies for neonatal seizures. Phenobarbital and phenytoin frequently fail to control seizures. There are concerns about the safety of seizure medications in the developing brain. Levetiracetam has proven efficacy and an excellent safety profile in older patients; therefore, there is great interest in its use in neonates. However, randomized studies have not been performed. Our objectives were to study the efficacy and safety of levetiracetam compared with phenobarbital as a first-line treatment of neonatal seizures. The study was a multicenter, randomized, blinded, controlled, phase IIb trial investigating the efficacy and safety of levetiracetam compared with phenobarbital as a first-line treatment for neonatal seizures of any cause. The primary outcome measure was complete seizure freedom for 24 hours, assessed by independent review of the EEGs by 2 neurophysiologists. Eighty percent of patients (24 of 30) randomly assigned to phenobarbital remained seizure free for 24 hours, compared with 28% of patients (15 of 53) randomly assigned to levetiracetam (P < .001; relative risk 0.35 [95% confidence interval: 0.22-0.56]; modified intention-to-treat population). A 7.5% improvement in efficacy was achieved with a dose escalation of levetiracetam from 40 to 60 mg/kg. More adverse effects were seen in subjects randomly assigned to phenobarbital (not statistically significant). In this phase IIb study, phenobarbital was more effective than levetiracetam for the treatment of neonatal seizures. Higher rates of adverse effects were seen with phenobarbital treatment. Higher-dose studies of levetiracetam are warranted, and definitive studies with long-term outcome measures are needed.
| S-EPMC7263056 | biostudies-literature
Project description:ObjectiveCompare neurodevelopment after levetiracetam (LEV) and phenobarbital (PB) for neonatal seizures.Study designRetrospective study of infants who received antiepileptic drugs (AEDs) for neonatal seizures. Effect of cumulative exposure to LEV and PB on outcomes of death, cerebral palsy (CP) and Bayley Scales of Infant Development (BSID) scores were evaluated at 24 months corrected age. Analyses were adjusted for number of electrographic seizures and gestational age.ResultIn 280 infants with comparable seizure etiology and cranial imaging results, increased exposure to PB was associated with worse BSID cognitive and motor scores (8.1- and 9-point decrease per 100 mg kg(-1); P=0.01). The effect was less with LEV (2.2- and 2.6-point decrease per 300 mg kg(-1) LEV (P=0.01)). CP probability increased by 2.3-fold per 100 mg kg(-1) PB and was not associated with increasing LEV.ConclusionIncreased exposure to PB is associated with worse neurodevelopmental outcomes than LEV. Prospective studies of outcomes of neonatal exposure to AEDs are essential.
| S-EPMC4000307 | biostudies-literature
Project description:ObjectiveSeizures are one of the most common neurologic complications seen in a neonate. Historically, phenobarbital has been the agent of choice, but can lead to adverse neurologic outcomes, which has contributed to the use of other agents. Levetiracetam has proven great efficacy with an excellent safety profile in older patients, causing interest of its use in neonates. The objective of this study was to determine if levetiracetam would provide similar neonatal seizure resolution rates as phenobarbital.MethodsThe study was a single-center, retrospective, cohort study from August 1, 2020 to August 31, 2022 investigating the efficacy and safety of using levetiracetam compared with phenobarbital as a first line treatment for neonatal seizures. The primary outcome was to assess overall seizure resolution after administration of levetiracetam or phenobarbital, without addition of a second antiseizure medication.ResultsThere were 87 patients included in the study. Fifteen neonates (27.78%) achieved seizure resolution with phenobarbital compared with 9 neonates (27.27%) who received levetiracetam first line (p = 0.959). Neonates who received phenobarbital had higher rates of adverse effects. Neonates who received a benzodiazepine prior to administration of levetiracetam had lower seizure resolution rates (p = 0.021).ConclusionsThese findings suggest there is no difference in using phenobarbital over levetiracetam to achieve complete seizure resolution in a neonate. Higher rates of adverse events were seen in the phenobarbital group. The use of a benzodiazepine prior to administration of levetiracetam may reduce the efficacy of levetiracetam.
| S-EPMC11472408 | biostudies-literature
Project description:Neonatal Abstinence Syndrome (NAS) is considered a Public Health problem that is defined as a group of symptoms that appear in the newborn due to withdrawal from intrauterine drug exposure. The aim of this study was to analyze the incidence of NAS in Castilla y León from 2000 to 2019. Data of NAS cases in Castilla y León from 2000 to 2019 were obtained. NAS incidence per 1000 births was calculated and the correlation among data from different provinces and years was analyzed. The cumulative incidence of NAS in Castilla y León per 1000 births between 2000-2019 was 0.91‱, with great interprovincial variability. The provinces of Zamora and Palencia stand out, with high incidence rates of NAS despite their low birth rates. The temporal trend points towards a decrease in incidence from 2000 to 2019. Opioids such as methadone, cannabis, benzodiazepines and poly-drug use are the most prevalent drugs causing NAS, and it has also been observed that methadone is being replaced by cannabis as the major cause of NAS cases at the University Hospital in Salamanca in recent years. The incidence of NAS in Castilla y León decreased in 2004 and remained constant until 2019, but it shows great interprovincial variability. It is necessary to implement a national NAS Registry to obtain comprehensive information regarding its incidence.
| S-EPMC8774299 | biostudies-literature
Project description:ObjectiveFew studies have evaluated the effect of phenobarbital (PB) on elevated direct bilirubin (DB) plasma concentrations in neonates and infants, and none have compared its effect with a control group with matched study baseline DB values. The purpose of this study was to quantify changes in elevated DB plasma concentrations (≥2 mg/dL) in neonates and infants between a PB-treated and control group.MethodsA retrospective, observational, matched, cohort study was performed comparing patients between a PB-treated group and a control group with similar study baseline plasma DB values ≥2 mg/dL over an 8-week period. The percent change in DB plasma concentrations from study baseline was compared for each week of the study period.ResultsDuring the 8-year study period, 310 patients had DB plasma concentrations ≥2 mg/dL, of which 26 remained in each group after exclusions. The PB group had increased DB concentrations and the control group had decreased DB concentrations when compared with their study baseline DB concentrations each week of the study period. By study end, the mean DB concentration increased by 11.2% in the PB group and decreased by 48.5% in the control group (p = 0.02). In multiple regression analysis, only birth weight (standardized coefficient = 0.44, p = 0.02), and gastrointestinal obstruction (standardized coefficient = -0.4, p = 0.03) were associated with significant percent change in DB concentrations.ConclusionsThis study demonstrated PB does not improve cholestasis in neonates and infants.
| S-EPMC9400188 | biostudies-literature
Project description:BackgroundNeonatal hypothermia is a worldwide problem and an important contributing factor for Neonatal morbidity and mortality especially in developing countries. High prevalence of hypothermia has been reported from countries with the highest burden of Neonatal mortality. So the aim of this study was to assess the prevalence of Neonatal hypothermia and associated factors among newborn admitted to Neonatal Intensive Care Unit of Public Hospitals in Addis Ababa.MethodsAn institutional based cross-sectional study was conducted from March 30 to April 30, 2016, in Public Hospitals in Addis Ababa and based on admission rate a total of 356 Neonates with their mother paired were enrolled for the study. Axillary temperate of the newborn was measured by a digital thermometer at the point of admission. Multivariate binary logistic regression, with 95% confidence interval and a p-value < 0.05 was used to identify variables which had a significant association.ResultsThe prevalence of Neonatal hypothermia in the study area was 64%. Preterm delivery (AOR = 4.81, 95% CI: 2.67, 8.64), age of Neonate ≤24 h old (AOR = 2.26, 95% CI: 1.27, 4.03), no skin to skin contact with their mother immediately after delivery (AOR = 4.39, 95% CI: 2.38, 8.11), delayed initiation of breastfeeding (AOR = 3.72, 95% CI: 2.07, 6.65) and resuscitation at birth (AOR = 3.65, 95%CI: 1.52, 8.78) were significantly associated with hypothermia.ConclusionsThe prevalence of Neonatal hypothermia in the study area was high. Preterm delivery, age ≤ 24 h old, no skin to skin contact immediately after delivery, delayed initiation of breastfeeding and resuscitation at birth were independent predictors of Neonatal hypothermia. Therefore attention is needed for thermal care of preterm newborn and use of low-cost thermal protection principles of warm chain especially on early initiation of breastfeeding, skin to skin contact immediately after delivery and warm resuscitation.
| S-EPMC6090740 | biostudies-literature
Project description:Background: Neonatal seizures are a common neurological emergency in newborns. Phenobarbital (PB) is the first-line antiepileptic drug (AED). However, PB has some side effects, such as hypotension and respiratory depression, and it can accelerate neuronal apoptosis in the immature brain. Levetiracetam (LEV), a new antiepileptic drug, has been used as a second-line drug for the treatment of neonatal seizures. Compared with PB, LEV has many advantages, including a low incidence of side effects and better neurodevelopmental outcomes. However, there are only a few systematic reviews of LEV for the treatment of neonatal seizures. Objective: To evaluate the efficacy and safety of LEV for neonatal seizures and to compare the efficacy, side effects, and neurological outcomes between LEV and PB in the treatment of neonatal seizures. Methods: The keywords LEV, PB, and neonatal seizure were searched in the MEDLINE, Cochrane Library, Web of Science, EMBASE, clinicaltrials.gov, and China National Knowledge Internet (CNKI) databases with a last update in July 2021 to collect high-quality studies. We collected studies studying the efficacy or safety of LEV and PB in the treatment of neonatal seizures applying strict inclusion and exclusion criteria. The data were extracted and outcome measures, including efficacy, side effect rate, neurological score, and mortality rate, were analyzed with RevMan 5.3 software. Results: Ten articles were finally included in the meta-analysis. The meta-analysis showed that there was no difference in efficacy between LEV and PB in the treatment of neonatal seizures. Compared with PB, the incidence of side effects of LEV was lower. The incidence of hypotension and respiratory depression in the LEV group was significantly lower than that in the PB group. In terms of long-term neurodevelopmental outcomes, there was no significant difference in the Bayley Scales of Infant Development (BSID) scores between LEV and PB. Conclusion: PB is still the first-line AED recommended by the WHO for the treatment of neonatal seizures. The new AEDs LEV may not have better efficacy than PB. At the same time, LEV is associated with better neurodevelopment outcomes and a lower risk of adverse effects. In addition, continuous EEG monitoring should be used to diagnose neonatal seizures to evaluate the severity of the seizures, remission, and drug efficacy. Systematic Review Registration: PROSPERO, identifier: CRD42021279029.
| S-EPMC8636327 | biostudies-literature
Project description:ObjectiveTo evaluate the effects of pharmacologic treatment of neonatal abstinence syndrome on neurodevelopmental outcome from a randomized, controlled trial.Study designEight sites enrolled 116 full-term newborn infants with neonatal abstinence syndrome born to mothers maintained on methadone or buprenorphine into a randomized trial of morphine vs methadone. Ninety-nine infants (85%) were evaluated at hospital discharge using the NICU Network Neurobehavioral Scale. At 18 months, 83 of 99 infants (83.8%) were evaluated with the Bayley Scales of Infant and Toddler Development-Third Edition and 77 of 99 (77.7%) with the Child Behavior Checklist (CBCL).ResultsPrimary analyses showed no significant differences between treatment groups on the NICU Network Neurobehavioral Scale, Bayley Scales of Infant and Toddler Development-Third Edition, or CBCL. However in post hoc analyses, we found differences by atypical NICU Network Neurobehavioral Scale profile on the CBCL. Infants receiving adjunctive phenobarbital had lower Bayley Scales of Infant and Toddler Development-Third Edition scores and more behavior problems on the CBCL. In adjusted analyses, internalizing and total behavior problems were associated with use of phenobarbital (P = .03; P = .04), maternal psychological distress (measured by the Brief Symptom Inventory) (both P < .01), and infant medical problems (both P = .02). Externalizing problems were associated with maternal psychological distress (P < .01) and continued maternal substance use (P < .01).ConclusionsInfants treated with either morphine or methadone had similar short-term and longer term neurobehavioral outcomes. Neurodevelopmental outcome may be related to the need for phenobarbital, overall health of the infant, and postnatal caregiving environment.Trial registrationClinicalTrials.gov: NCT01958476.
| S-EPMC7161698 | biostudies-literature
Project description:BackgroundEthiopia witnessed an unprecedented decline in under-5 and neonatal mortalities since 2000. But, neonatal mortality still accounts for the largest proportion of under-five child mortality. Quality of service at hospitals may vary and determine the magnitude of neonatal mortality.ObjectiveTo assess the prevalence and associated factors of neonatal mortality among newborns Admitted to the Neonatal intensive care unit of Gandhi Memorial Hospital Addis Ababa, Ethiopia, 2019.MethodsInstitution-based cross-sectional study was conducted from November 1 to December 31, 2019. A sample of one in every 2 admitted patients was included in the study. our exclusion criterion was neonates who had no mothers or guardians and/or neonatal medical records incomplete for status at discharge. We used the Systematic random sampling technique to select the study participants. A pretested structured interviewer-administered questionnaire and a preliminary tested checklist were used to collect primary and secondary data respectively. Descriptive and summary statistics were performed. A binary logistic regression model was fitted and variables that had a P-value of < 0.05 in the multivariable model were considered statistically significant.ResultsA total of 570 neonates who have mothers were involved in the study giving a response rate of 98.8%. The prevalence of neonatal mortality was 7.7% (95% CI: 5.7, 9.8). Mothers' educational status (No education (AOR 3.37, CI 95%, 1.02-11.20), premature rupture of membrane (prolonged PROM) (AOR 5.59, CI 95%, 1.05-29.76), and birth weight less than 2500gm (AOR 3.23, CI 95%, 1.17-8.90) are the significant factors associated with neonatal mortality.ConclusionThe prevalence of neonatal mortality at Gandhi memorial hospital was generally high. As our finding revealed, neonates who are underweight and whose mothers have no formal education as well as have prolonged PROM have higher odds of neonatal mortality. Thus, clinicians, policymakers, and program managers should give special attention to neonates of none educated mothers, mothers with prolonged PROM, and neonates with low birth weight.
| S-EPMC9097131 | biostudies-literature