| CTRI Number |
CTRI/2023/02/049794 [Registered on: 16/02/2023] Trial Registered Prospectively |
| Last Modified On: |
04/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study comparing efficacy of two drugs as first line drug in late preterm and term babies with Neonatal Seizure. |
|
Scientific Title of Study
|
Phenobarbitone versus Levetiracetam as 1st line therapy for Neonatal Seizures- A Randomized 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 Shivangi Singh |
| Designation |
RESIDENT |
| Affiliation |
TATA Main Hospital |
| Address |
Department of Paediatrics,
TATA Main Hospital
Bistupur
Jamshedpur-831001
Department of Paediatrics,
TATA Main Hospital
Bistupur
Jamshedpur-831001
Purbi Singhbhum
JHARKHAND
831001
India |
| Phone |
9836909210 |
| Fax |
|
| Email |
shivangisingh2911@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Bhupendra Kumar Gupta |
| Designation |
Consultant |
| Affiliation |
TATA Main Hospital |
| Address |
Department of Paediatrics,
TATA Main Hospital
Bistupur
Jamshedpur
Purbi Singhbhum
JHARKHAND
831001
India |
| Phone |
|
| Fax |
|
| Email |
bhupendra.gupta@tatasteel.com |
|
Details of Contact Person
Public Query
|
| Name |
Bhupendra Kumar Gupta |
| Designation |
Consultant |
| Affiliation |
TATA Main Hospital |
| Address |
Department of Paediatrics,
TATA Main Hospital
Bistupur
Jamshedpur
Sahibganj
JHARKHAND
831001
India |
| Phone |
|
| Fax |
|
| Email |
bhupendra.gupta@tatasteel.com |
|
|
Source of Monetary or Material Support
|
| Department of Pediatrics
TATA MAIN HOSPITAL
Bistupur
Jamshedpur-831001 |
|
|
Primary Sponsor
|
| Name |
TATA MAIN HOSPITAL |
| Address |
Department of Pediatrics
TATA Main Hospital
Bistupur |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Shivangi Singh |
Tata Main Hospital |
Department of Pediatrics
TATA Main Hospital
Bistupur
Purbi Singhbhum
JHARKHAND |
09836909210
shivangisingh2911@gmail.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 |
(1) ICD-10 Condition: G404||Other generalized epilepsy and epileptic syndromes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Levetiracetam |
Inj Levetiracetam (40mg/kg then 20mg/kg) as 1st line drug in Neonatal Seizures given over 20 minutes. |
| Comparator Agent |
Phenobarbitone |
Inj Phenobarbitone (20mg/kg then 20mg/kg) loading dose is the standard 1st line drug of Neonatal Seizure given over 20 minutes |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
All term and late pre-term neonates (>35weeks of gestation) with clinically apparent seizures and lasting for 3 minutes. |
|
| ExclusionCriteria |
| Details |
Neonates-
1. Who had received any previous anticonvulsants.
2. With correctable metabolic abnormalities(like hypoglycemia/hypocalcemia)
3. With myoclonic jerks.
4. With major congenital malformation or syndromes |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Termination of clinical seizures (seizure control in 60 minutes and no further seizure in 24 hours) |
Termination of clinical seizures (seizure control in 60 minutes and no further seizure in 24 hours) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Cessation of Seizure for 48 hours
2. Survival at discharge
3. Duration of hospital stay
4. Adverse event occuring within 2 hours of drug administration. |
48 hours |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
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
|
N/A |
|
Date of First Enrollment (India)
|
28/02/2023 |
| 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) |
Not Yet Recruiting |
|
Publication Details
|
NOT YET PUBLISHED |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
•Neonatal seizures affect 1 to 4/1000 newborns and are associated with poor outcomes. •Up to one third of the infants with neonatal seizures die, and half of survivors have permanent disabilities. •Mortality and morbidity of neonatal seizures are in large part attributed to the underlying condition; however, there is mounting evidence that seizures themselves are harmful, especially in the asphyxiated neonatal brain. •Phenobarbital is the most frequently used first line anti-epileptic drug for neonatal seizure, however, phenobarbitone is effective in controlling seizure in 40-70% of babies only. •Levetiracetam has good efficacy and an excellent safety profile in children and adult population. •Because the neonatal response to anticonvulsants is fundamentally different from that of the older brain, specific study of levetiracetam within the neonatal population is essential •Drugs that are effective in terminating seizures in older patients may be less effective and more toxic in neonates.
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