| CTRI Number |
CTRI/2013/04/003585 [Registered on: 26/04/2013] Trial Registered Retrospectively |
| Last Modified On: |
26/04/2013 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Levetiracetam for management of seizures in newborn |
|
Scientific Title of Study
|
Levetiracetam in neonatal seizures -a randomised study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rabindran |
| Designation |
DNB Neonatology Registrar |
| Affiliation |
Rainbow Children’s Hospital |
| Address |
Name- Dr. Rabindran,
Official address- Rainbow Children’s Hospital, Plot No 22,Road No 10, Banjara Hilla, Hyderabad-500034.
Affiliation- Rainbow Children’s Hospital
Rainbow Children’s Hospital, Plot No 22,Road No 10, Banjara Hilla, Hyderabad-500034.
Hyderabad
ANDHRA PRADESH
500034
India |
| Phone |
8712307790 |
| Fax |
|
| Email |
rabindranindia@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rabindran |
| Designation |
DNB Neonatology Registrar |
| Affiliation |
Rainbow Children’s Hospital |
| Address |
Name- Dr. Rabindran,
Official address- Rainbow Children’s Hospital, Plot No 22,Road No 10, Banjara Hilla, Hyderabad-500034.
Affiliation- Rainbow Children’s Hospital
Rainbow Children’s Hospital, Plot No 22,Road No 10, Banjara Hilla, Hyderabad-500034.
Hyderabad
ANDHRA PRADESH
500034
India |
| Phone |
8712307790 |
| Fax |
|
| Email |
rabindranindia@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Venkatlakshmi |
| Designation |
consultant pediatrician |
| Affiliation |
Rainbow Children’s Hospital |
| Address |
Rainbow Children’s Hospital, Plot No 22,Road No 10, Banjara Hilla, Hyderabad-500034.
Rainbow Children’s Hospital, Plot No 22,Road No 10, Banjara Hilla, Hyderabad-500034.
Hyderabad
ANDHRA PRADESH
500034
India |
| Phone |
9849489897 |
| Fax |
|
| Email |
drvenkatlakshmi@rainbowhospitals.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Rainbow Childrens Hospital |
| Address |
Official address- Rainbow Children’s Hospital, Plot No 22,Road No 10, Banjara Hilla, Hyderabad-500034.
Affiliation- Rainbow Children’s Hospital
|
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| rabindran |
Rainbow Children’s Hospital |
Name- Dr. Rabindran,
Official address-NICU,SECOND FLOOR, Rainbow Children’s Hospital, Plot No 22,Road No 10, Banjara Hilla, Hyderabad-500034.
Hyderabad
ANDHRA PRADESH |
8712307790
rabindranindia@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| HOSPITAL ETHICS COMMITTEE RAINBOW CHILDRENS HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
neonatal seizure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Levetiracetam
|
20 mg/kg as loading dose followed by 10 mg/kg per dose twice daily as maintenance dose ,maintenance dose to be continued till baby is seizure free and tapered and stopped as per neurologist opinion |
| Intervention |
phenobarbitone |
20 mg/kg as loading dose followed by 5 mg/kg /day maintenance in two divided doses,continued till baby is seizure free and tapered and stopped as per neurologist opinion. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
30.00 Day(s) |
| Gender |
Both |
| Details |
Babies admitted to NICU with seizures and babies having seizures during NICU stay with
• Gestational age ≥ 30 wks Birth weight ≥ 1.5 kg Clinical or electrographic seizures Parental consent obtained
|
|
| ExclusionCriteria |
| Details |
Babies with renal serum creatinine > 2.0
Birth at < 30 weeks gestation Parents refuse consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the therapeutic benefit of levetiracetum in neonatal seizures and to compare efficacy with other antiseizure medication. |
30/06/2013 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| use of leviteracetam in various types of neonatal seizures |
30/6/2013 |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
06/03/2012 |
| 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="1"
Months="5"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
to study the therapeutic benefit of levetiracetam in neonatal seizures and to compare efficacy with other anticonvulsant medication.
|