Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
66 participants
INTERVENTIONAL
2026-01-01
2026-10-31
Brief Summary
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Detailed Description
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Baseline data as detailed medical history, physical examination, gestational age, postnatal age, birth weight, APGAR score at 5 and 10 minutes. Laboratory parameter (complete blood cell count, electrolytes, serum creatinine, liver enzymes, and blood gas), respiratory assessment (need for oxygen and respiratory support), cardiac assessment including (blood pressure/ heart rate), type of feeding, head ultrasound.
The enrolled patients will be classified into three groups: Phenobarbital group (intervention group A), Levetiracetam standard dose group (intervention group B), Levetiracetam high dose group (intervention group C).
Patients in Group A (intervention group I) will receive phenobarbital at a loading dose of 20 mg/kg within a 20-minute time frame from the start of seizures. If the seizures doesn't stopped after 20 minutes, another 20 mg/kg of the same medication will be added, and if the seizures doesn't stopped within the total time frame of 40 minutes, this will be considered a treatment failure.
While patients in Group B (Intervention Group II) as well as Group C (Control Group) will receive levetiracetam at a loading dose of 30 mg/kg and 60 mg/kg respectively. Within a timeframe of 20 minutes from the start of seizures, If the seizures doesn't stopped. The same beginning dose will be repeated for both groups, in case of seizures doesn't stopped within the 40-minute time frame, which leads to the treatment being considered a failure and a need to move to the second line of treatment.
For all groups, if the first line of treatment fails, phenytoin will be considered as the second line treatment for treating seizures, and a dose of (20 mg/kg diluted in 20 ml of saline solution over 20 minutes) will be started. If the seizures is not controlled, the third line will be midazolam, given as a continuous infusion.
Evaluations will include patients who will be followed up during the study period by measuring the following parameters: frequent episodes of seizure/ time to stop seizures, EEG finding, follow-up head ultrasound (US) and brain magnetic resonance imaging (MRI) (if the neonate-stable), blood pressure/ heart rate (need for inotrope/vasopressor treatment), respiratory status (need for oxygen and respiratory support), feeding intolerance (vomiting); and changes in laboratory parameters (complete blood cell count to assess anemia, electrolytes, serum creatinine, liver enzymes, ammonia, and arterial blood gas (ABG) analysis or any significant side effects that were attributed to an anti-seizures medication by the clinical team and will be recorded in the medical record.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Phenobarbital Arm ( Group A )
Patients in Group A will receive PHENobarbital at a loading dose of 20 mg/kg within a 20-minute time frame from the start of treatment. If the seizure dose is not stopped after 20 minutes, another 20 mg/kg of the same medication will be added, and if the seizure dose is not stopped within the total time frame of 40 minutes, this will be considered a treatment failure. If seizures are controlled, patients will receive a maintenance dose of PHENobarbital 3-5 mg/kg/day IV/PO, in 1-2 divided doses, starting 12 hours after the loading dose.
Phenobarbital
Phenobarbital is strongly recommended by the World Health Organization as the first-line treatment of neonatal seizures and is the standard of care at most institutions
Levetiracetam Standard Dose Arm ( Group B )
Patients in Group B will receive levETIRAcetam at a loading dose of 30 mg/kg within a timeframe of 20 minutes from the start of seizures if the seizures don't stop. The same beginning dose will be repeated, in case the seizures don't stop within the 40-minute time frame, which leads to the treatment being considered a failure and a need to move to the second line of treatment. If seizures are controlled, patients will receive maintenance dose of levETIRAcetam 30 mg/kg/day IV or orally, divided into three daily doses.
Levetiracetam
levetiracetam has emerged as an alternative Anti-seizure medication that may offer improved safety and tolerability profiles.
Levetiracetam High Dose Arm ( Group C )
Patients in Group C will receive levETIRAcetam at a loading dose of 60 mg/kg within a timeframe of 20 minutes from the start of seizures if the seizures don't stop. The same beginning dose will be repeated, in case the seizures don't stop within the 40-minute time frame, which leads to the treatment being considered a failure and a need to move to the second line of treatment. If seizures are controlled, patients will receive maintenance dose of levETIRAcetam 60 mg/kg/day IV or orally, divided into three daily doses.
Levetiracetam
levetiracetam has emerged as an alternative Anti-seizure medication that may offer improved safety and tolerability profiles.
Interventions
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Phenobarbital
Phenobarbital is strongly recommended by the World Health Organization as the first-line treatment of neonatal seizures and is the standard of care at most institutions
Levetiracetam
levetiracetam has emerged as an alternative Anti-seizure medication that may offer improved safety and tolerability profiles.
Eligibility Criteria
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Inclusion Criteria
2. Presence of clinical seizures (focal / generalized tonic /colonic, myoclonic, subtle and spasms) and/or documented amplitude electroencephalogram (aEEG) abnormality within the first 72 hours.
Exclusion Criteria
2. Serum creatinine greater than 1.6 mg/dl.
3. Known pyridoxine-dependent seizures.
4. Prior treatment with anti-epileptic drugs.
1 Day
30 Days
ALL
No
Sponsors
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Mansoura University
OTHER
Responsible Party
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Abdulwahab Uosef Alqarni, M.Sc
Mansoura University, PhD student
Principal Investigators
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Moetaza Soliman, Associate Professor
Role: PRINCIPAL_INVESTIGATOR
Faculty of Pharmacy, Mansoura University
Nada Abdelfattah, Associate Professor
Role: PRINCIPAL_INVESTIGATOR
University Children's Hospital, Mansoura University
Locations
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University Children's Hospital, Mansoura University
Al Mansurah, , Egypt
Al Galaa Teaching Hospital
Cairo, , Egypt
Countries
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Central Contacts
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References
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Finster M, Wood M. The Apgar score has survived the test of time. Anesthesiology. 2005 Apr;102(4):855-7. doi: 10.1097/00000542-200504000-00022.
Sarnat HB, Sarnat MS. Neonatal encephalopathy following fetal distress. A clinical and electroencephalographic study. Arch Neurol. 1976 Oct;33(10):696-705. doi: 10.1001/archneur.1976.00500100030012.
Susnerwala S, Joshi A, Deshmukh L, Londhe A. Levetiracetam or Phenobarbitone as a First-Line Anticonvulsant in Asphyxiated Term Newborns? An Open-Label, Single-Center, Randomized, Controlled, Pragmatic Trial. Hosp Pediatr. 2022 Jul 1;12(7):647-653. doi: 10.1542/hpeds.2021-006415.
Qiao MY, Cui HT, Zhao LZ, Miao JK, Chen QX. Efficacy and Safety of Levetiracetam vs. Phenobarbital for Neonatal Seizures: A Systematic Review and Meta-Analysis. Front Neurol. 2021 Nov 18;12:747745. doi: 10.3389/fneur.2021.747745. eCollection 2021.
Gyandeep G, Behura SS, Sahu SK, Panda SK. Comparison between Phenobarbitone and Levetiracetam as the initial anticonvulsant in preterm neonatal seizures - a pilot randomized control trial in developing country setup. Eur J Pediatr. 2023 May;182(5):2133-2138. doi: 10.1007/s00431-023-04864-x. Epub 2023 Feb 24.
Verwoerd C, Limjoco J, Rajamanickam V, Knox A. Efficacy of Levetiracetam and Phenobarbital as First-Line Treatment for Neonatal Seizures. J Child Neurol. 2022 Apr;37(5):401-409. doi: 10.1177/08830738221086107. Epub 2022 Mar 20.
Efficacy of levetiracetam as the first line anti- epileptic drug in management of neonatal seizures
Battig L, Dunner C, Cserpan D, Ruegger A, Hagmann C, Schmitt B, Pisani F, Ramantani G. Levetiracetam versus Phenobarbital for Neonatal Seizures: A Retrospective Cohort Study. Pediatr Neurol. 2023 Jan;138:62-70. doi: 10.1016/j.pediatrneurol.2022.10.004. Epub 2022 Oct 22.
Sharpe C, Reiner GE, Davis SL, Nespeca M, Gold JJ, Rasmussen M, Kuperman R, Harbert MJ, Michelson D, Joe P, Wang S, Rismanchi N, Le NM, Mower A, Kim J, Battin MR, Lane B, Honold J, Knodel E, Arnell K, Bridge R, Lee L, Ernstrom K, Raman R, Haas RH; NEOLEV2 INVESTIGATORS. Levetiracetam Versus Phenobarbital for Neonatal Seizures: A Randomized Controlled Trial. Pediatrics. 2020 Jun;145(6):e20193182. doi: 10.1542/peds.2019-3182. Epub 2020 May 8.
Hooper RG, Ramaswamy VV, Wahid RM, Satodia P, Bhulani A. Levetiracetam as the first-line treatment for neonatal seizures: a systematic review and meta-analysis. Dev Med Child Neurol. 2021 Nov;63(11):1283-1293. doi: 10.1111/dmcn.14943. Epub 2021 Jun 13.
Akeel NE, Suliman HA, Al-Shokary AH, Ibrahim AO, Kamal NM, Abdelgalil AA, Elmala MK, Elshorbagy HH, Nasef KA, Attia AM, Fathallah MGED. A Comparative Study of Levetiracetam and Phenobarbital for Neonatal Seizures as a First Line Treatment. Glob Pediatr Health. 2022 Dec 20;9:2333794X221143572. doi: 10.1177/2333794X221143572. eCollection 2022.
Other Identifiers
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MDP.25.01.179
Identifier Type: -
Identifier Source: org_study_id