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Efficacy of antiepileptic drugs in neonatal seizures: a systematic review protocol
Yang He1,2, Jun Tang1,2, Meng Zhang1,2
1Key Laboratory of Obstetrics & Gynecologic and Pediatric Diseases and Birth Defects of the Ministry of Education, Sichuan University, Chengdu, China.
Insights
This systematic review evaluates antiepileptic drugs (AEDs) for neonatal seizures, assessing efficacy and long-term outcomes like cerebral palsy and epilepsy. It aims to clarify treatment effectiveness for these critical infant neurological events.
Area of Science:
- Neonatal neurology
- Pharmacology
- Systematic reviews
Background:
- Neonatal seizures are common and require urgent treatment, with current first-line antiepileptic drugs (AEDs) effective in only 50% of cases.
- The efficacy of newer AEDs, like levetiracetam, for neonatal seizures is uncertain, necessitating further investigation.
- Long-term neurodevelopmental outcomes, including cerebral palsy and epilepsy, following neonatal seizures require comprehensive study.
Approach:
- A systematic review will be conducted, including randomized controlled trials, cohort studies, case-controlled studies, and case series.
- Searches will cover major databases (PubMed, Embase, Web of Science, Cochrane Library, ClinicalTrials.gov) without language restrictions.
- Risk of bias will be assessed using the Cochrane risk-of-bias tool and Newcastle-Ottawa Scale; a Bayesian network meta-analysis or narrative review will be performed based on study homogeneity.
Key Points:
- Primary outcomes include electroencephalogram-confirmed seizure cessation and long-term neurodevelopmental outcomes.
- Secondary outcomes encompass in-hospital neonatal mortality and adverse drug events (suspected toxicity).
- Subgroup analyses will explore efficacy across different AEDs and dosage regimens.
Conclusions:
- This systematic review will provide a comprehensive evaluation of AED efficacy for neonatal seizures.
- It will elucidate the short-term and long-term impacts of these treatments on infant neurodevelopment.
- Findings will inform clinical practice and guide future research in neonatal seizure management.
Introduction:
Seizures are one of the most common neurological disorders of neonates, which is also an emergency in the neonatal intensive care unit. For neonates, the recommended first-line antiepileptic drugs (AEDs) include phenobarbitone, which may be effective in only 50% of seizures. Some new AEDs, such as levetiracetam, have been shown to be effective in adults and older children. However, their efficacy for neonatal seizures remains uncertain. The aim of this investigation is to conduct a systematic review to evaluate the efficacy of all AEDs in neonates. Additionally, the long-term outcomes following neonatal seizures, in relation to the development of cerebral palsy and epilepsy, will be studied.
Method:
We will perform a systematic review including randomised controlled studies (RCTs), cohort studies, case-controlled studies and case series studies which evaluated the efficacy of AEDs and short-term and long-term outcomes in neonatal seizures. PubMed, Embase, Web of Science, Cochrane Library and Clinical trial.gov will be searched. There will be no language restriction. Risk bias in RCTs will be evaluated by the Cochrane risk-of-bias tool, while cohort and case-control studies will be evaluated by the Newcastle-Ottawa Scale. A network meta-analysis will be performed by the Bayesian model using WinBUGS V.1.4.3 and R software if there is a high degree of homogeneity among studies. Otherwise, we will perform a narrative review without pooling. Subgroup analyses will be performed in different AEDs and dosage groups.
Outcome:
The primary outcomes will be seizure cessation confirmed by electroencephalogram and long-term neurodevelopmental outcome. Secondary outcomes will be neonatal mortality during hospitalisation and suspected drug toxicity.
Ethics And Dissemination:
Formal ethical approval is not required as no primary data are collected. This systematic review will be disseminated through a peer-reviewed publication.
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