| CTRI Number |
CTRI/2020/03/023961 [Registered on: 13/03/2020] Trial Registered Prospectively |
| Last Modified On: |
17/12/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Levetiracetam versus Phenobarbitone for treatment of neonatal seizure. |
|
Scientific Title of Study
|
A RANDOMIZED CONTROLLED TRIAL OF LEVETIRACETAM VERSUS PHENOBARBITONE FOR TREATMENT OF NEONATAL SEIZURE |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Devdarshan Nitin Gandhi |
| Designation |
MD Pediatrics student |
| Affiliation |
Narayan Medical College and Hospital |
| Address |
Room no. 13, Department of Paediatrics, Narayan Medical college and hospital, Jamuhar, Sasaram.
Rohtas
BIHAR
821115
India |
| Phone |
8368646999 |
| Fax |
|
| Email |
devdarshan.gandhi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mani Kant Kumar |
| Designation |
Guide, Professor and HOD, Department of Pediatrics |
| Affiliation |
Narayan Medical College and Hospital |
| Address |
Room no. 13, Department of Paediatrics, Narayan Medical College and Hospital, Jamuhar, Sasaram.
Rohtas
BIHAR
821115
India |
| Phone |
9162095353 |
| Fax |
|
| Email |
manikant7@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Devdarshan Nitin Gandhi |
| Designation |
MD Pediatrics student |
| Affiliation |
Narayan Medical College and Hospital |
| Address |
Room no. 13, Department of Paediatrics, Narayan Medical College and Hospital.
Rohtas
BIHAR
821115
India |
| Phone |
8368646999 |
| Fax |
|
| Email |
devdarshan.gandhi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Paediatrics, Narayan Medical College and Hospital, Jamuhar, Sasaram, Bihar. |
|
|
Primary Sponsor
|
| Name |
Dr Devdarshan Nitin Gandhi |
| Address |
Room no. 13, Department of Paediatrics, Narayan Medical college and Hospital, Jamuhar, Sasaram |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Devdarshan Nitin Gandhi |
Narayan Medical College and Hospital |
NICU, Department of Paediatrics, Narayan Medical College and Hospital, Jamuhar, Sasaram, Bihar.
Rohtas
BIHAR |
8368646999
devdarshan.gandhi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Narayan Medical College and Hospital, Ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P90||Convulsions of newborn, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Inj. Levetiracetam |
Inj. Levetiracetam,
I/V,
1st Loading - 20 mg/kg - stat,
2nd Loading - 10 mg/kg - SOS (if seizure is not controlled by first loading),
Maintenance - 10 mg/kg - BD,
Syrup Levetiracetam,
Maintenance - 10 mg/kg - P/O - BD X 1 month |
| Comparator Agent |
Inj. Phenobarbitone |
Inj. Phenobarbitone,
I/V,
1st Loading - 20 mg/kg - stat,
2nd Loading - 10 mg/kg - SOS (if seizure is not controlled by first loading dose),
Maintenance - 5 mg/kg - BD,
Syrup Phenobarbitone,
Maintenance - 5 mg/kg - P/O - BD x 1 month |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
All inborn and outborn neonates (age 0-28 days) between 35 weeks to 42 weeks of gestational age admitted in NICU with clinical seizures will be enrolled in the study.
For this study we will be considering subtle seizure, tonic seizures, clonic seizures and myoclonic seizures. |
|
| ExclusionCriteria |
| Details |
--Major congenital malformation
--Need for assisted ventilation at the time of admission
--Refractory shock
--Serum creatinine >2 mg/dl
--Anticonvulsant prior to admission
--Neonates with hypoglycaemia, hypocalcemia or hypo / hyperkalemia. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate efficacy of Levetiracetam versus Phenobarbitone in controlling neonatal seizures. |
Whether seizure is controlled within 1 hour or not.
And time taken for clinical control of seizure. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Recurrence of seizure |
Within 24 hours of administration of the 1st or 2nd loading dose. |
| Adverse effect: Respiratory depression / Apnoea / Desaturation |
Within 8 hours of administration of drug |
| Adverse effect: Heart rate fluctuations |
Within 8 hours of administration of drug |
| Duration of hospitalization |
Number of days child was admitted in NICU |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/03/2020 |
| Date of Study Completion (India) |
07/09/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Phenobarbitone is the drug of choice for neonatal seizures irrespective of the cause of seizures. But the adverse effects of Phenobarbitone on developing brain are well established. So there is a dire need for a newer and safer alternative to Phenobarbitone. Levetiracetam is a relatively newer antiepileptic drug. Studies in elder children and adults have shown some promising results. But the studies pertaining to its use in neonatal seizures is rather limited. Few randomized controlled trials show the superiority of Levetiracetam over Phenobarbitone. But the numbers of randomized controlled trials are very much limited. We aim to conduct this study with the objective to compare the efficacy and safety of Levetiracetam versus Phenobarbitone in the treatment of neonatal seizures. Keywords: Neonatal seizures, Phenobarbitone, Levetiracetam |