| CTRI Number |
CTRI/2013/01/003310 [Registered on: 21/01/2013] Trial Registered Retrospectively |
| Last Modified On: |
12/01/2013 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
comparison of levetiracetam with phenobarbitone in neonatal seizure |
|
Scientific Title of Study
|
comparison of levetiracetam with phenobarbitone for the treatment of seizure in term and near term neonates. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amit Upadhyay |
| Designation |
Assistant Prof and Head |
| Affiliation |
LLRM MEDICAL COLLEGE |
| Address |
DEPARTMENT OF PEDIATRICS
LLRM MEDICAL COLLEGE
MEERUT
D-8 SHASHTRINAGAR MEERUT
Meerut
UTTAR PRADESH
240001
India |
| Phone |
0937405009 |
| Fax |
0121-2760888 |
| Email |
anuamit7@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Upadhyay |
| Designation |
ASSISTANT PROFESSOR AND HEAD |
| Affiliation |
LLRM MEDICAL COLLEGE |
| Address |
DEPARTMENT OF PEDIATRICS
LLRM MEDICAL COLLEGE
MEERUT
D-8 SHASHTRINAGAR MEERUT
Meerut
UTTAR PRADESH
240001
India |
| Phone |
0937405009 |
| Fax |
|
| Email |
ANUAMIT7@REDIFFMAIL.COM |
|
Details of Contact Person
Public Query
|
| Name |
Dr Monica roy |
| Designation |
junior resident |
| Affiliation |
LLRM MEDICAL COLLEGE |
| Address |
DEPARTMENT OF PEDIATRICS
LLRM MEDICAL COLLEGE
MEERUT
ROOM NO.10,P.G GIRLS HOSTEL,L.L.R.M MEDICAL COLLEGE,MEERUT
Meerut
UTTAR PRADESH
240001
India |
| Phone |
9528844910 |
| Fax |
|
| Email |
keepsmiling_444@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Government medical college |
|
|
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 AMIT UPADHYAY |
LLRM Medical College |
Deptt of pediatrics,LLRM MEDICAL COLLEGE, MEERUT
Meerut
UTTAR PRADESH |
09837405009
anuamit7@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
all neonates with convulsion of any cause, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
levetiracetam |
levetiracetam to be loaded @ 60mg/kg/dose to be diluted in normal saline given over 5-10 minutes |
| Comparator Agent |
phenobarbitone |
At 1st episode of convulsion phenobarbitone will be given @20mg/kg/dose in dilution with normal saline over 15-20 minutes slowly under cardio respiratory monitoring.At second episode of convulsion if baby is in phenobarbitone group then it will be given @10mg/kg/dose in dilution with normal saline over 10-15 minutes under cardiorespiratory monitoring. |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
all newborns <28 days with convulsions of any cause. |
|
| ExclusionCriteria |
| Details |
babies on mechanical ventilation and with refractory shock |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| control of clinical seizure |
24 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
side effects of levetiracetam
nuerological outcome at age 3,6,12 months |
12 months |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
11/06/2012 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Phenobarbitone is the drug of choice in neonatal seizure but known to have long term effect on neonatal brain..Levetiracetam is a newer antiepileptic and its efficacy not being fully established in neonates. It has not been known to have abnormal nuerological effect instead in previous studies it has been to be proved to have nueroprotective..so it has been compared with phenobarbitone. |