| CTRI Number |
CTRI/2020/04/024952 [Registered on: 30/04/2020] Trial Registered Prospectively |
| Last Modified On: |
27/04/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A study to control the effectiveness of two drugs, which are phenobarbitone (used for seizures in first 28 days of life) and levetiracetam ( new drug for seizures) in newborns who have seizures in the first 24 hours of life with delayed cry at birth. |
|
Scientific Title of Study
|
Efficacy of Levetiracetam versus
Phenobarbitone in the control of neonatal seizures in asphyxiated newborns as first line therapy: a randomised controlled trial
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shradha zutshi |
| Designation |
Junior resident |
| Affiliation |
Pt. BD Sharma PGIMS Rohtak |
| Address |
Department of pediatrics
PT. B.D. Sharma PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9916762791 |
| Fax |
|
| Email |
shradhazutshi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Virender gehlawat |
| Designation |
Associate professor |
| Affiliation |
Pt. BD Sharma PGIMS Rohtak |
| Address |
Department of pediatrics
PT.B.D Sharma PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9812768686 |
| Fax |
|
| Email |
gehlawatv@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shradha zutshi |
| Designation |
Junior resident |
| Affiliation |
Pt. BD Sharma PGIMS Rohtak |
| Address |
PT. B.D.sharma PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9916762791 |
| Fax |
|
| Email |
shradhazutshi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of pediatrics and neonatology, PGIMS,. Rohtak |
|
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Primary Sponsor
|
| Name |
Department of neonatology and pediatrics |
| Address |
PT.B D Sharma PGIMS Rohtak |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Shradha zutshi |
PT. BD Sharma PGIMS, rohtak |
PT. BD Sharma PGIMS, rohtak
Department of neonatology and pediatrics
Rohtak
HARYANA |
9916762791
shradhazutshi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical research committee, PGIMS Rohtak |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G998||Other specified disorders of nervous system in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Comparing efficacy of levetiracetam and phenobarbitone in control of neonatal seizures due to perinatal asphyxia |
Neonates will be loaded with IV levetiracetam in a dose of 40mg/kg diluted in 30ml of Normal saline infused over 15-20 minutes. If seizures are controlled with levetiracetam, maintenance will be continued (20 mg/kg/day). If seizures persist after the loading dose of levetiracetam, neonates will be given another loading with IV levetiracetam in a dose of 20 mg/kg. If seizures persist, the neonates will be crossed over to treatment with IV phenobarbitone as per unit defined treatment dose. |
| Comparator Agent |
Comparing efficacy of levetiracetam and phenobarbitone in control of neonatal seizures due to perinatal asphyxia |
Neonates will be loaded with IV phenobarbitone in dose of 20mg/kg under strict cardio respiratory monitoring. If seizures are controlled with phenobarbitone, maintenance will be continued (3 mg/kg/day). If seizures persist after the loading dose of phenobarbitone, neonates will be given another loading with IV phenobarbitone in a dose of 10 mg/kg. If seizures persist, the neonates will be crossed over to treatment with IV levetiracetam as per unit defined treatment dose. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
Full termGestational age more than equal to 37 weeks
Birth weight more than or equal to2 kgs
Perinatal asphyxia defined as:APGAR score less than 5 at 5 minutes, Cord pH less than 7.0, Base deficit more than12 : in deliveries attended by the pediatrician at the hospital
, Delayed onset of cry after 3 min of birth in deliveries not attended by doctor or at home.
HIE with clinical seizures : onset within 24 hours of life
Inborn neonates admitted on day one of life
|
|
| ExclusionCriteria |
| Details |
Anticonvulsant prior to admission
Neonatal seizures due to proven metabolic causes: hypoglycemia, hypocalcaemia, etc.
Neonates who are treated with therapeutic hypothermia
Serum creatinine levels > 1.5mg/dl
Gross congenital malformations
TORCH infections
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
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Primary Outcome
|
| Outcome |
TimePoints |
| Clinical and electrical control (using aEEG) of seizure activity in the neonates within one hour of loading with the drug and no recurrence for the next 24 hours. |
1 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Short term toxicity of levetiracetam will be monitored:Apnea within 4 hour period following Levetiracetam infusion,Anaphylactic shock occurring following the levetiracetam infusion, toxic epidermic necrosis Steven Johnson syndrome,Serum creatinine levels
2. Any adverse effects with phenobarbitone will be monitored: Irritability, Sedation, Hypotension,Respiratory suppression,hepatotoxicity
|
1 day |
|
|
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 1 |
|
Date of First Enrollment (India)
|
01/05/2020 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
This study is an open labe RCT, which will be done in department of neonatology and pediatrics PGIMS Rohtak to compare the efficacy of levetiracetam and phenobarbitone in the control of neonatal seizures due to perinatal asphyxia. Continuous EEG monitoring will be done to detect subclinical cassestion of seizures and at the same time adverse effects of both the drugs will be monitored. |