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Trial registered on ANZCTR


Registration number
ACTRN12622000470796
Ethics application status
Approved
Date submitted
20/09/2021
Date registered
25/03/2022
Date last updated
11/05/2022
Date data sharing statement initially provided
25/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title

EFFICACY AND SAFETY OF levetiracetam versus phenytoin for neonatal seizures.A randomized controlled trial.
Scientific title
Efficacy and safety of Levetricetam Versus Phenytoin for Neonatal Seizures: A Randomized Controlled Trial
Secondary ID [1] 305314 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
neonatal seizures 323655 0
Condition category
Condition code
Neurological 321194 321194 0 0
Epilepsy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will receive one loading dose levetiracetam of 5-10mg/kg intravenously over 15 minutes following identification of seizures.
This maintenance dose 10mg/kg intravenously will be started 12 hours after the first loading dose
The maintenance dose will be given once daily thereafter until termination of seizures."

Intervention code [1] 321744 0
Treatment: Drugs
Comparator / control treatment

Active Comparator: Intravenous Phenytoin
Single Loading: 15 - 20 mg/kg Intravenous after that the Maintenance dose of 5 - 8 mg/kg/day 24 HOURS after the first loading dose
This maintenance dose will be repeated every 12 hours thereafter until termination of seizures."
Control group
Active

Outcomes
Primary outcome [1] 328987 0
termination of seizures within 24 hours assessed by a physical examination conducted by a pediatrician.
Timepoint [1] 328987 0
continuous 24 hours monitoring post-intervention commencement
Primary outcome [2] 328988 0
continuous monitoring for 5 days for terminations of seizures within 5 days assesses by physical examination conducted by a pediatrician post intervention commencement.
Timepoint [2] 328988 0
continuous physical monitoring 5 DAYS post intervention commencement .
Secondary outcome [1] 401028 0

ADVERSE EFFECTS: Occurrence within two hours of drug administration, including desaturation, reduced respiratory rate, arrhythmias, blood pressure, or heart rate fluctuations by more than 10% compared to the previous 2 hours, or if vasopressors were initiated or increased, were recorded
CTCAE 5.0 GRADE 2.
Timepoint [1] 401028 0
continuous daily observation for 5 days post-intervention commencement

Eligibility
Key inclusion criteria
Neonates till 30 days of life both male/female with seizures.
Minimum age
1 Hours
Maximum age
30 Days
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Neonates with hypoglycemia, hypocalcemia, hypomagnesemia, those who received anticonvulsants prior to enrolment, and those with major congenital malformations e.g., congenital heart defects, neural tube malformations, diaphragmatic hernia, choanal atresia, esophageal atresia, tracheoesophageal
fistula, omphalocele, gastroschisis, intestinal obstruction and imperforate anus) were excluded.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
12/05/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
184
Accrual to date
Final
Recruitment outside Australia
Country [1] 24125 0
Pakistan
State/province [1] 24125 0
kyber Pakhtunkhuwa

Funding & Sponsors
Funding source category [1] 309681 0
Self funded/Unfunded
Name [1] 309681 0
DR KHAWAJA KAMRAN WAJID
Country [1] 309681 0
Pakistan
Primary sponsor type
Individual
Name
DR KHWAJA KAMRAN WAJID
Address
PEDIATRIC WARD ,LADY READING HOSPITAL MTI ,PESHAWAR., KHYBER PAKHTUNKHWA,25000
Country
Pakistan
Secondary sponsor category [1] 310703 0
Individual
Name [1] 310703 0
DR AMIR MUHAMMAD
Address [1] 310703 0
PEDIATRIC WARD ,LADY READING HOSPITAL MTI ,PESHAWAR., KHYBER PAKHTUNKHWA25000
Country [1] 310703 0
Pakistan

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309448 0
INSTITUTIONAL Research and ethical committee ,mti lady reading hospital peshawar.
Ethics committee address [1] 309448 0
Soekarno Rd, PTCL Colony, Peshawar, Khyber Pakhtunkhwa 25000
Ethics committee country [1] 309448 0
Pakistan
Date submitted for ethics approval [1] 309448 0
14/12/2020
Approval date [1] 309448 0
21/12/2020
Ethics approval number [1] 309448 0
646

Summary
Brief summary
"The rationale of this study is that neonatal seizure is a treatable condition and the present anticonvulsants used are not much efficient as well as not safe in neonates in controlling the seizures. Therefore, we want to compare the efficacy and adverse effects between both Phenytoin and Levetricetam which will help in finding the best drug controlling the neonatal seizures quickly with minimal adverse effects. We hypothesise that levetiracetam is more effective and safe than phenytoin in termination of seizures
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 114198 0
Dr khawaja kamran wajid
Address 114198 0
Pediatric ward lady reading hospital mti ,peshawar ,khyber pukhtunhuwa,25000
Country 114198 0
Pakistan
Phone 114198 0
+923159732426
Fax 114198 0
Email 114198 0
drkamo50@gmail.com
Contact person for public queries
Name 114199 0
A/Prof dr amir muhammad
Address 114199 0
Pediatric ward lady reading hospital mti ,peshawar ,khyber pukhtunhuwa,25000
Country 114199 0
Pakistan
Phone 114199 0
+923125098679
Fax 114199 0
Email 114199 0
amirmuhammad786@yahoo.com
Contact person for scientific queries
Name 114200 0
Dr dr khawaja kamran wajid
Address 114200 0
Pediatric ward lady reading hospital mti ,peshawar ,khyber pukhtunhuwa,25000
Country 114200 0
Pakistan
Phone 114200 0
+923159732426
Fax 114200 0
Email 114200 0
drkamo50@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13282Ethical approval    382785-(Uploaded-20-09-2021-19-22-24)-Study-related document.docx



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.