| CTRI Number |
CTRI/2016/10/007412 [Registered on: 27/10/2016] Trial Registered Prospectively |
| Last Modified On: |
02/11/2016 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical Study to compare Levetiracetam and Phenobarbitone in Newborns with Birth Asphyxia |
|
Scientific Title of Study
|
To Compare Efficacy and Safety of Levetiracetam with Phenobarbitone in Neonates with Perinatal Asphyxia: A Randomized Controlled Trial |
| Trial Acronym |
LeveNeo Trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shahid Akhtar Siddiqui |
| Designation |
Senior Resident |
| Affiliation |
Moti Lal Nehru Medical College Allahabad |
| Address |
Sarojini Naidu Children Hospital, Deptt of Pediatrics, Moti Lal Nehru
Medical College, Church Lane, Allahabad.
Allahabad
UTTAR PRADESH
211002
India |
| Phone |
09559441844 |
| Fax |
|
| Email |
sha.akht@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manisha Maurya MD |
| Designation |
Assistant Professor |
| Affiliation |
Moti Lal Nehru Medical College Allahabad |
| Address |
Sarojini Naidu Children Hospital, Deptt of Pediatrics, Moti Lal Nehru
Medical College, Church Lane, Allahabad.
Allahabad
UTTAR PRADESH
211002
India |
| Phone |
09335982127 |
| Fax |
|
| Email |
drmanisha99@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manisha Maurya MD |
| Designation |
Assistant Professor |
| Affiliation |
Moti Lal Nehru Medical College Allahabad |
| Address |
Sarojini Naidu Children Hospital, Deptt of Pediatrics, Moti Lal Nehru
Medical College, Church Lane, Allahabad.
Allahabad
UTTAR PRADESH
211002
India |
| Phone |
09335982127 |
| Fax |
|
| Email |
drmanisha99@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sarojini Naidu Children Hospital |
| Address |
Sarojini Naidu Children Hospital, Department of Pediatrics, Moti Lal Nehru
Medical College, Church Lane, Allahabad. |
| 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 Shahid Akhtar Siddiqui |
Sarojini Naidu Children Hospital (SNCH) |
Sarojini Naidu Children Hospital, Department of Pediatrics, Moti Lal Nehru
Medical College, Church Lane Allahabad 211002.
Allahabad
UTTAR PRADESH |
09559441844
sha.akht@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Moti Lal Nehru Medical College, Allahabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Levetiracetam in Perinatal Asphyxia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Levetiracetam |
Initial loading dose of 20 mg/kg followed by maintenance dose of 20 mg/kg/day in 2 divided doses to a maximum of 60 mg/kg/day. |
| Comparator Agent |
Phenobarbitone |
Initial loading dose of 20 mg/kg followed by maintenance dose of 3 mg/kg/day as a single dose to a maximum of 5 mg/kg/day. |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
1.00 Day(s) |
| Gender |
Both |
| Details |
Full term neonates (37 completed weeks to less than 42 weeks of gestational age)
Less than 24 hours of age at presentation
HIE stage II or III (as per Sarnat and Sarnat staging)
|
|
| ExclusionCriteria |
| Details |
Neonates received at least one dose of anticonvulsants
Severe congenital anomalies or CNS malformations
Convulsions due to hypoglycemia/hypocalcemia
Neonatal Sepsis
Major intracranial hemorrhage
Serum creatinine more than 0.8 mg/dl
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Control of Neonatal Seizures with first anticonvulsant
Need of second anticonvulsant
Neonatal Mortality during first week of life
Neurological status at discharge |
First week of life (Early Neonatal period) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Safety profile of Levetiracetam
Duration of Hospital Stay
Neurological Status and Development on follow up visits |
First year of life |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 4 |
|
Date of First Enrollment (India)
|
01/11/2016 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a single centre randomized, single blind, parallel group, active controlled trial comparing the efficacy and safety of Levetiracetam with Phenobarbitone in Neonates with Perinatal Asphyxia. |