OBJECTIVE: The study goal was to determine whether clonidine treatment of neonatal abstinence syndrome (NAS) would result in a better neurobehavioral performance compared with morphine.METHODS: This pilot study prospectively enrolled infants $35 weeks' gestational age admitted for treatment of NAS. After informed consent was obtained, infants were randomized to receive morphine (0.4 mg/kg per day) or clonidine (5 mg/kg per day) divided into 8 doses. A 25% dose escalation every 24 hours was possible per protocol (maximum of 1 mg/kg per day for morphine and 12 mg/kg per day for clonidine). After control of symptoms, the dose was tapered by 10% every other day. Clinical staff monitored infants by using Finnegan scoring. Masked research staff administered the NICU Network Neurobehavioral Scale (NNNS) at 1 week and at 2 to 4 weeks after initiation of treatment and the Bayley Scales III, and Preschool Language Scale IV, at 1-year adjusted age. Analyses included descriptive statistics, repeated measures analysis of variance, and Wilcoxon tests.RESULTS: Infants treated with morphine (n = 15) versus clonidine (n = 16) did not differ in birth weight or age at treatment. Treatment duration was significantly longer for morphine (median 39 days) than for clonidine (median 28 days; P = .02). NNNS summary scores improved significantly with clonidine but not with morphine. On subsequent assessment, those receiving clonidine had lower height of arousal and excitability (P , .05). One-year motor, cognitive, and language scores did not differ between groups.CONCLUSIONS: Clonidine may be a favorable alternative to morphine as a single-drug therapy for NAS. A multicenter randomized trial is warranted. WHAT'S KNOWN ON THIS SUBJECT:Increased central adrenergic activity occurs with opiate withdrawal. Clonidine is an effective drug as an adjunct to morphine in the treatment of neonatal abstinence syndrome. It is unclear whether clonidine is effective as single-drug therapy.WHAT THIS STUDY ADDS: Clonidine, a a 2 -adrenergic agonist, seems to be as effective as morphine when used as a single-drug therapy for neonatal abstinence syndrome. Its administration results in improvement in neurobehavioral performance.
OBJECTIVE Optimal treatment for neonatal seizures remains unclear, and management among US hospitals is highly varied. The purpose of this study was to evaluate the effectiveness of levetiracetam as a first-line treatment for seizures in a neonatal population. METHODS A single-center, retrospective review of neonates at a tertiary medical center who received levetiracetam as a first-line agent after benzodiazepines for seizure control between 2015 and 2017 was conducted. Chart review was completed to analyze patient and treatment characteristics. The primary outcome was seizure control, defined as clinical seizure cessation and video electroencephalogram resolution, with no new seizures documented prior to discharge. RESULTS A total of 36 patients met inclusion criteria. Seventeen patients (47%) had seizure control after intravenous levetiracetam as monotherapy. Eighteen patients required a second anticonvulsant, of which 13 (72%) had seizure control. In total, 30 patients (83%) had seizure control with levetiracetam monotherapy or combination therapy of levetiracetam plus fosphenytoin or phenobarbital. CONCLUSIONS Levetiracetam monotherapy provided seizure control in about 50% of the patients reviewed. Overall, seizure control was observed in 83% of the study population that received either levetiracetam monotherapy or combination therapy of levetiracetam plus fosphenytoin or phenobarbital as a second-line agent. Further studies are warranted to directly compare historical therapies with levetiracetam for neonatal seizure control.
OBJECTIVES The objectives of the study were to compare the free serum concentrations after different fosphenytoin loading dose strategies in patients younger than 6 months old and to investigate the frequency of seizure cessation following a loading dose of fosphenytoin. METHODS This retrospective cohort study included neonates and infants admitted to a 150-bed children's hospital between August 1, 2014, and February 1, 2018. Patients were included if they were younger than 6 months old and had a postload free phenytoin serum concentration collected during the specified time frame. Patients were identified through a database query screening for the inclusion criteria. Patients were separated into 2 groups with the 15 mg/kg group as per protocol and the 20 mg/kg group as noted in common practice. Data collection included demographic information, fosphenytoin dose, time of administration of the fosphenytoin loading dose, time of sampling, free phenytoin serum concentration results, concomitant antiepileptic agents, albumin serum concentration, and total bilirubin serum concentration. RESULTS Forty-one patients were included for analysis, 12 in the 15 mg/kg group and 29 in the 20 mg/kg group. The average free phenytoin concentration after the loading dose was 2.45 ± 0.54 mg/L in the 15 mg/kg group and 2.52 ± 0.66 mg/L in the 20 mg/kg group. Seizure cessation after the fosphenytoin loading dose was achieved in 3 of 12 (25%) patients in the 15 mg/kg group and in 13 of 29 (45%) patients in the 20 mg/kg group (p = 0.305). CONCLUSIONS The study demonstrates that a traditional range of fosphenytoin loading dose (15–20 mg/kg) led to elevated postloading dose free phenytoin serum concentrations in the majority of patients with a seizure cessation rate of approximately 39%. The question remains as to what the optimal dose and target concentration should be in this patient population to achieve the best efficacy without risking associated toxicities.
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