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Tytuł:
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Effect of early withdrawal of phenobarbitone on the recurrence of neonatal seizures: An open-label randomized controlled trial.
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Autorzy:
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Jindal A; Department of Pediatrics, Advanced Pediatric Centre, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.
Angurana SK; Division of Pediatric Critical Care, Department of Pediatrics, Advanced Pediatric Centre, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India. Electronic address: .
Suthar R; Division of Pediatric Neurology, Department of Pediatrics, Advanced Pediatric Centre, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.
Kumar P; Division of Neonatology, Department of Pediatrics, Advanced Pediatric Centre, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.
Sundaram V; Division of Neonatology, Department of Pediatrics, Advanced Pediatric Centre, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.
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Źródło:
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Epilepsy & behavior : E&B [Epilepsy Behav] 2021 Apr; Vol. 117, pp. 107875. Date of Electronic Publication: 2021 Mar 08.
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Typ publikacji:
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Journal Article; Randomized Controlled Trial
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Język:
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English
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Imprint Name(s):
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Original Publication: San Diego, CA : Academic Press, c2000-
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MeSH Terms:
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Epilepsy*/drug therapy
Phenobarbital*/therapeutic use
Anticonvulsants/therapeutic use ; Child ; Humans ; India ; Infant, Newborn ; Seizures/drug therapy
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Contributed Indexing:
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Keywords: Anticonvulsant; Neonatal seizures; Phenobarbitone; Seizure recurrence
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Substance Nomenclature:
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0 (Anticonvulsants)
YQE403BP4D (Phenobarbital)
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Entry Date(s):
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Date Created: 20210311 Date Completed: 20210420 Latest Revision: 20210420
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Update Code:
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20240104
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DOI:
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10.1016/j.yebeh.2021.107875
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PMID:
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33706247
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Background: The long-term administration of phenobarbitone in neonates may be associated with adverse neurological outcome. The timing of stopping phenobarbitone maintenance after acute seizure control in neonates is a matter of debate.
Objectives: To study the effect of early withdrawal of phenobarbitone on recurrence of neonatal seizures.
Study Design: Open-label randomized controlled trial.
Participants: Outborn neonates (≥34 weeks of gestation to <28 days of postnatal period) with seizures (n = 221) admitted to Neonatal unit in Pediatric emergency of a tertiary care hospital in north India over 1 year.
Intervention: After a loading dose of phenobarbitone (20 mg/kg), neonates who remained seizure free for at least 12 h were enrolled after written informed consent from parents, and randomized (computer generated block randomization) to 'phenobarbitone withdrawal group' (n = 112) where phenobarbitone maintenance was stopped and 'phenobarbitone continued group' (n = 109) where phenobarbitone maintenance was continued until discharge and further as per clinician's discretion.
Outcomes: The primary outcome was seizure recurrence until discharge and secondary outcomes were time to reach full enteral feeds, duration of hospital stay, abnormal neurological status at discharge, and mortality in two groups.
Results: The baseline variables were comparable in 2 groups. The incidence of seizure recurrence was similar in the phenobarbitone withdrawal and phenobarbitone continued groups (50% vs. 37.6%, respectively, p = 0.078). Among secondary outcomes, the phenobarbitone withdrawal and continued groups had similar time to reach full enteral feeds (4.02 days vs. 4.2 days, p = 0.75), duration of hospital stay (6.3 days vs. 6.5 days, p = 0.23), abnormal neurological status at discharge (45.6% vs. 38%, p = 0.39), and mortality (11.6% vs. 8.3%, p = 0.50).
Conclusion: Early withdrawal of phenobarbitone in neonatal seizures does not lead to a significant increase in the rate of seizure recurrence.
Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(Copyright © 2021 Elsevier Inc. All rights reserved.)
