Importance Antiseizure medication (ASM) treatment duration for acute symptomatic neonatal seizures is variable. A randomized clinical trial of phenobarbital compared with placebo after resolution of acute symptomatic seizures closed early owing to low enrollment. Objective To assess whether ASM discontinuation after resolution of acute symptomatic neonatal seizures and before hospital discharge is associated with functional neurodevelopment or risk of epilepsy at age 24 months. Design, Setting, and Participants This comparative effectiveness study included 303 neonates with acute symptomatic seizures (282 with follow-up data and 270 with the primary outcome measure) from 9 US Neonatal Seizure Registry centers, born from July 2015 to March 2018. The centers all had level IV neonatal intensive care units and comprehensive pediatric epilepsy programs. Data were analyzed from June 2020 to February 2021. Exposures The primary exposure was duration of ASM treatment dichotomized as ASM discontinued vs ASM maintained at the time of discharge from the neonatal seizure admission. To enhance causal association, each outcome risk was adjusted for propensity to receive ASM at discharge. Propensity for ASM maintenance was defined by a logistic regression model including seizure cause, gestational age, therapeutic hypothermia, worst electroencephalogram background, days of electroencephalogram seizures, and discharge examination (allP ≤ .10 in a joint model except cause, which was included for face validity). Main Outcomes and Measures Functional neurodevelopment was assessed by the Warner Initial Developmental Evaluation of Adaptive and Functional Skills (WIDEA-FS) at 24 months powered for propensity-adjusted noninferiority of early ASM discontinuation. Postneonatal epilepsy, a prespecified secondary outcome, was defined per International League Against Epilepsy criteria, determined by parent interview, and corroborated by medical records. Results Most neonates (194 of 303 [64%]) had ASM maintained at the time of hospital discharge. Among 270 children evaluated at 24 months (mean [SD], 23.8 [0.7] months; 147 [54%] were male), the WIDEA-FS score was similar for the infants whose ASMs were discontinued (101 of 270 [37%]) compared with the infants with ASMs maintained (169 of 270 [63%]) at discharge (median score, 165 [interquartile range, 150-175] vs 161 [interquartile range, 129-174];P = .09). The propensity-adjusted average difference was 4 points (90% CI, −3 to 11 points), which met the a priori noninferiority limit of −12 points. The epilepsy risk was similar (11% vs 14%;P = .49), with a propensity-adjusted odds ratio of 1.5 (95% CI, 0.7-3.4;P = .32). Conclusions and Relevance In this comparative effectiveness study, no difference was found in functional neurodevelopment or epilepsy at age 24 months among children whose ASM was discontinued vs maintained at hospital discharge after resolution of acute symptomatic neonatal seizures. These results support discontinuation of ASM prior to hospital discharge for most infants with acute symptomatic neonatal seizures.

/pdf/safety-of-early-discontinuation-of-antiseizure-medication-bsmo3bn315.pdf

Safety of Early Discontinuation of Antiseizure Medication After Acute Symptomatic Neonatal Seizures.

Seizures are common in neonates, but there is substantial management variability. The Neonatal Task Force of the International League Against Epilepsy (ILAE) developed evidence‐based recommendations about antiseizure medication (ASM) management in neonates in accordance with ILAE standards. Six priority questions were formulated, a systematic literature review and meta‐analysis were performed, and results were reported following the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta‐Analyses) 2020 standards. Bias was evaluated using the Cochrane tool and risk of Bias in non‐randomised studies ‐ of interventions (ROBINS‐I), and quality of evidence was evaluated using grading of recommendations, assessment, development and evaluation (GRADE). If insufficient evidence was available, then expert opinion was sought using Delphi consensus methodology. The strength of recommendations was defined according to the ILAE Clinical Practice Guidelines development tool. There were six main recommendations. First, phenobarbital should be the first‐line ASM (evidence‐based recommendation) regardless of etiology (expert agreement), unless channelopathy is likely the cause for seizures (e.g., due to family history), in which case phenytoin or carbamazepine should be used. Second, among neonates with seizures not responding to first‐line ASM, phenytoin, levetiracetam, midazolam, or lidocaine may be used as a second‐line ASM (expert agreement). In neonates with cardiac disorders, levetiracetam may be the preferred second‐line ASM (expert agreement). Third, following cessation of acute provoked seizures without evidence for neonatal‐onset epilepsy, ASMs should be discontinued before discharge home, regardless of magnetic resonance imaging or electroencephalographic findings (expert agreement). Fourth, therapeutic hypothermia may reduce seizure burden in neonates with hypoxic–ischemic encephalopathy (evidence‐based recommendation). Fifth, treating neonatal seizures (including electrographic‐only seizures) to achieve a lower seizure burden may be associated with improved outcome (expert agreement). Sixth, a trial of pyridoxine may be attempted in neonates presenting with clinical features of vitamin B6‐dependent epilepsy and seizures unresponsive to second‐line ASM (expert agreement). Additional considerations include a standardized pathway for the management of neonatal seizures in each neonatal unit and informing parents/guardians about the diagnosis of seizures and initial treatment options.

Treatment of seizures in the neonate: Guidelines and consensus‐based recommendations—Special report from the ILAE Task Force on Neonatal Seizures

Background and Objectives Clinicians often communicate complex, uncertain, and distressing information about neurologic prognosis to parents of critically ill infants. Although communication tools have been developed in other disciplines and settings, none address the unique needs of the neonatal and pediatric neurology context. We aimed to develop a parent-informed framework to guide clinicians in communicating information about neurologic prognosis. Methods Parents of infants with neurologic conditions in the intensive care unit were enrolled in a longitudinal study of shared decision-making from 2018 to 2020. Parents completed semistructured interviews following recorded family meetings with the health care team, at hospital discharge, and 6 months after discharge. All interviews targeted information about parent preferences for prognostic disclosure. We analyzed the data using a conventional content analysis approach. Two study team members independently coded all interview transcripts, and discrepancies were resolved in consensus. We used NVIVO 12 qualitative software to index and organize codes. Results Fifty-two parents of 37 infants completed 123 interviews. Parents were predominantly mothers (n = 37/52, 71%) with a median age of 31 (range 19–46) years. Half were Black (n = 26/52, 50%), and a minority reported Hispanic ethnicity (n = 2/52, 4%). Inductive analysis resulted in the emergence of 5 phases of prognostic communication (Approach, Learn, Inform, Give support, and Next steps: ALIGN): (1) Approach: parents appreciated receiving consistent information about their child's neurologic outcome from clinicians who knew their child well. (2) Learn: parents valued when clinicians asked them how they preferred receiving information and what they already knew about their child's outcome prior to information delivery. (3) Inform: parents valued honest, thorough, and balanced information that disclosed prognostic uncertainty and acknowledged room for hope. (4) Give support: parents valued empathic communication and appreciated clinicians who offered real-time emotional support. (5) Next steps: parents appreciated clinicians who connected them to resources, including peer support. Discussion The ALIGN framework offers a novel, parent-informed strategy to effectively communicate neurologic prognosis. Although ALIGN represents key elements of a conversation about prognosis, each clinician can adapt this framework to their own approach. Future work will assess the effectiveness of this framework on communication quality and prognostic understanding. 

The ALIGN Framework

Neonates and families face challenges in hypothermic therapy, including trauma to parents, extreme emotions, and unfamiliarity with the medical system. Communication is an essential element to supporting parents while their children are in the NICU, and beyond, building the foundation for the ongoing relationship the family has with the medical system. Significant consideration needs to be given to the critical element of integrating the family into the care of a baby being treated with therapeutic hypothermia. Clinicians can promote healing of accumulated traumas of parents through ensuring parent's emotional safety, facilitating a trusting relationship, and promoting parent empowerment. Connecting parents with resources, especially peer support, is an essential part of a hospital stay. In this chapter, we explore best practices to support families during and after hypothermic therapy.

Supporting families in their child's journey with neonatal encephalopathy and therapeutic hypothermia

Family-Centered Care for Children and Families Impacted by Neonatal Seizures: Advice From Parents.

Objective Neonates with seizures have a high risk of mortality and neurological morbidity. We aimed to describe the experience of parents caring for neonates with seizures. Design This prospective, observational and multicentre (Neonatal Seizure Registry) study enrolled parents of neonates with acute symptomatic seizures. At the time of hospital discharge, parents answered six open-ended response questions that targeted their experience. Responses were analysed using a conventional content analysis approach. Results 144 parents completed the open-ended questions (732 total comments). Four themes were identified. Sources of strength: families valued medical team consensus, opportunities to contribute to their child’s care and bonding with their infant. Uncertainty: parents reported three primary types of uncertainty, all of which caused distress: (1) the daily uncertainty of the intensive care experience; (2) concerns about their child’s uncertain future and (3) lack of consensus between members of the medical team. Adapting family life: parents described the many ways in which they anticipated their infant’s condition would lead to adaptations in their family life, including adjusting their family’s lifestyle, parenting approach and routine. Many parents described financial and work challenges due to caring for a child with medical needs. Emotional and physical toll: parents reported experiencing anxiety, fear, stress, helplessness and loss of sleep. Conclusions Parents of neonates with seizures face challenges as they adapt to and find meaning in their role as a parent of a child with medical needs. Future interventions should target facilitating parent involvement in clinical and developmental care, improving team consensus and reducing the burden associated with prognostic uncertainty.

https://fn.bmj.com/content/fetalneonatal/105/6/634.full.pdf

Parent experience of caring for neonates with seizures.

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Parent experience of caring for neonates with seizures.