Dear Sir,
We read with much interest the article by Falsaperla et al., published in the recent issue of your journal,[1] but at the same time would like to make the following comments, clarification to which would benefit the general readers of JPN.
The abstract mentions the study period to be “from January to August 2016” but the materials and methods section state it to be “July 2015 to July 2016.” This makes the readers wonder about the actual period of the study.
The materials and methods section mentions that preterm and “on-term” neonates “with signs and/or symptoms of the convulsive disease and/or hypoxic-ischemic disease” “who needed anticonvulsant therapy” were included. This makes one wonder whether neonates with hypoxic-ischemic encephalopathy who did not have seizure and might have actually not required antiepileptic, were also included in the study. Again, the authors also mention that the neonates were “randomly included.” It is not clear whether they meant any form of “random sampling” such as “simple random sampling” or they had chosen the participants at their will/convenience or actually they are presenting selective data of neonates with seizure who received levetiracetam as the first-line agent among all such neonates in their nursery! This leads to a serious concern of “selection bias” in the study.[2] As they also do not mention how the sample size was calculated,[3] this issue of presentation of “selective data” of patients is further suspected.
It is mentioned that “magnetic resonance imaging was performed in 40% of cases” but 40% of total cases (16) comes to be 6.4!
The text in results mention that “Electroencephalogram (EEG) study before treatment showed the presence of brushes in 12.5% of patients, diffuse cortical involvement in 12.5% of cases, and centrotemporal spikes in 12.5% of patients,” while Figure 2 presents “Video EEG alterations of the studied patients before the onset of symptoms (?)” reveal tonic–clonic seizure in 50%, delta brushes in 12.5%, spikes in 25%, and cortical cerebral sufferance (?) in 12.5%! Again, the symptomatology [Figure 1] describes tonic–clonic convulsions in 12.5%. First, tonic–clonic seizure is a clinical diagnosis and not an EEG feature. Second, generalized tonic–clonic seizure being extremely rare in newborns, it is very surprising to have either 12.5% or 50% of newborns to have the same. On the other hand, subtle seizure, which is the most common type of seizure in this age group,[4] was not seen in cohort.
Figure 2.
Video electroencephalogram alterations of the studied patients before the onset of symptoms
Figure 1.
Symptoms for which levetiracetam was started in the studied population
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REFERENCES
- 1.Falsaperla R, Vitaliti G, Mauceri L, Romano C, Pavone P, Motamed-Gorji N, et al. Levetiracetam in neonatal seizures as first-line treatment: A prospective study. J Pediatr Neurosci. 2017;12:24–8. doi: 10.4103/jpn.JPN_172_16. [DOI] [PMC free article] [PubMed] [Google Scholar]
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