| CTRI Number |
CTRI/2015/06/005849 [Registered on: 03/06/2015] Trial Registered Retrospectively |
| Last Modified On: |
17/07/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To see if Levetiracetam, a new seizure control medication is better over older medication Phenobarbitone for immediate neonatal seizure control. |
|
Scientific Title of Study
|
Levetiracetam vs Phenobarbitone in acute neonatal seizures - a Randomised Control Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nikhil D Kulkarni |
| Designation |
MD Pediatrics, DM resident |
| Affiliation |
St Johns Medical College and Hospital, Bangalore - 34 |
| Address |
Dept. of Neonatology,
1st floor, St. Johns Medical College Hospital, Sarjapur Road,
Bangalore
Bangalore
KARNATAKA
560034
India |
| Phone |
9916785482 |
| Fax |
|
| Email |
drnikhilkulkarni83@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suman Rao |
| Designation |
MD Pediatrics, DM Neonatology |
| Affiliation |
St Johns Medical College and Hospital, Bangalore - 34 |
| Address |
Dept. of Neonatology,
1st floor, St. Johns Medical College Hospital, Sarjapur Road,
Bangalore
Dept. of Neonatology,
1st floor, St. Johns Medical College Hospital, Sarjapur Road,
Bangalore
Bangalore
KARNATAKA
560034
India |
| Phone |
9916785482 |
| Fax |
|
| Email |
raosumanv@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nikhil D Kulkarni |
| Designation |
MD Pediatrics, DM resident |
| Affiliation |
|
| Address |
Dept. of Neonatology,
1st floor, St. Johns Medical College Hospital, Sarjapur Road,
Bangalore
Bangalore
KARNATAKA
560034
India |
| Phone |
9916785482 |
| Fax |
|
| Email |
drnikhilkulkarni83@gmail.com |
|
|
Source of Monetary or Material Support
|
| St. Johns Medical cpllege Hospital |
|
|
Primary Sponsor
|
| Name |
Dr Nikhil D Kulkarni |
| Address |
Dept. of Neonatology,
St.Johns Medical college Hospital,
Bangalore - 34 |
| Type of Sponsor |
Other [self sponsored] |
|
|
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 Nikhil D Kulkarni |
NICU, St Johns Medical College Hospital |
1st Floor, St. Johns Medical College Hospital, Sarjapur Road, Bangalore
Bangalore
KARNATAKA |
9916785482
drnikhilkulkarni83@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| St Johns Medical College & Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
neonatal seizures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Levetiracetam |
In acute management of neonatal seizures to give 30 mg/kg/dose loading followed by 10 mg/kg/dose if seizure recurs and drug to be maintained at 20 mg/kg/day in BD dose |
| Comparator Agent |
Phenobarbitone |
In acute neonatal seizures to be given as 20 mg/kg/dose followed by 10 mg/kg/dose if seizure recurs and drug to be maintained at 5 mg/kg/day in BD dose |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
1.00 Month(s) |
| Gender |
Both |
| Details |
1)> 1000 g birth weight and > 28 weeks gestation.
2)all term neonates |
|
| ExclusionCriteria |
| Details |
1)hypoglycemic seizures
2)neonates treated with anticonvulsants prior to admission |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Recurrence of seizure and need for another anticonvulsant. |
Immediately on the day of seizure i.e. within 24 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Monitoring of adverse drug reactions of each drug like Phenobarbitone toxicity, mortality and neurodevelopmental follow up in follow up clinic. |
After treatment of seizures within 7 days and on followup at 1 month, 3 months,6 months, 9 months, 12 months, 15 months, 18 months and 24 months. |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
Final Enrollment numbers achieved (Total)= "38"
Final Enrollment numbers achieved (India)="38" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/10/2013 |
| Date of Study Completion (India) |
30/04/2015 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/04/2015 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Hypothesis: In acute management of neonatal seizures, intravenous Levetiracetam 30 mg/kg/dose as against 20 mg/kg/dose of Phenobarbitone achieves 50% more seizure control clinically at 7 days as compared to Phenobarbitone. Purpose: To find a better, safe and effective anticonvulsant in the management of acute neonatal seizures. |