To identify the optimized treatment of infantile spasm in infants.
Design
Open label randomized control trial will be conducted at neurology department of the Children’s Hospital and the Institute of Child Health Multan, Pakistan
Settings and conduct
This open label randomized control trial will be conducted at neurology department of the Children’s Hospital and the Institute of Child Health Multan, Pakistan from November 2020 to October 2023. Total 320 infants (160 each group) will be included in this study.
The study was approved by the ethical committee of Children Hospital and institute of Child Health, Multan.
Participants/Inclusion and exclusion criteria
Written informed consent
Children aged one to 12 months, of both genders
clinical diagnosis of infantile spasm made according to international league against epilepsy plus hypsarrhythmia on EEG (EEG records were graded using the Burden of Amplitudes and Epileptiform Discharges (BASED) scoring system) will be included.
Exclusion criteria will be: Infantile spasm due to tuberous sclerosis, previous treatment with steroids or vigabatrin, contraindication to steroids/vigabatrin
Intervention groups
Children will be divided into two groups by random allocation for the selection of treatment protocol. Children receiving prednisolone will be assigned as group A and those receiving vigabatrin plus prednisolone as group B. Sealed opaque envelope system will be used for randomization. These pre- written, sealed envelopes will be opened at the time of start of treatment.
Main outcome variables
Primary end point will be the electroclinical remission (cessation of spasms plus resolution of
hypsarrhythmia). Resolution of hypsarrhythmia will be defined as BASED score ≤ 2 at day 14.
Secondary end points will be the time to electroclinical remission, relapse after initial response, adverse effects of treatment and developmental progress.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200414047072N2
Registration date:2020-11-06, 1399/08/16
Registration timing:registered_while_recruiting
Last update:2020-11-06, 1399/08/16
Update count:0
Registration date
2020-11-06, 1399/08/16
Registrant information
Name
Saba Fatima
Name of organization / entity
Hilton Pharma Pvt. Ltd.
Country
Pakistan
Phone
+92 21 35072224
Email address
sabafatima@hiltonpharma.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-10, 1399/05/20
Expected recruitment end date
2021-08-10, 1400/05/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy and safety of corticosteroids and vigabatrin plus corticosteroids in infantile spasm: An open label randomized control trial
Public title
Efficacy and Safety of corticosteroids and vigabatrin plus corticosteroids in infantile spasm
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Signed informed consent from parents/guardians
Children aged one to 12 months
Both genders with clinical diagnosis of infantile spasm made according to international league against epilepsy plus hypsarrhythmia on EEG (EEG records were graded using the Burden of Amplitudes and Epileptiform Discharges (BASED) scoring system
Exclusion criteria:
Infantile spasm due to tuberous sclerosis
Previous treatment with steroids or vigabatrin
Contraindication to steroids/vigabatrin (fever, active infection and hypertension).
Age
From 1 month old to 12 months old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
320
Randomization (investigator's opinion)
Randomized
Randomization description
Its an open label randomized control trial design and Simple random sampling was occurred, where one group is taken single medicine while other group is taking medicine in combination. Individual unit of randomization where choose
Total 320 infants (160 each group), according to international league against epilepsy plus hypsarrhythmia on EEG (EEG records were graded using the Burden of Amplitudes and Epileptiform Discharges (BASED) scoring system) will be included. Sealed opaque envelope system will be used for randomization. These pre- written, sealed envelopes will be opened at the time of start of treatment. real time physical random sequence will be done.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Children's Hospital & the Institute of Child Health, Multan.
Epileptic spasms, not intractable, without status epilepticus
Primary outcomes
1
Description
Electroclinical remission (cessation of spasms plus resolution ofhypsarrhythmia)
Timepoint
Before intervention and Day 4, 7, 14, 21, 28, 42, 60, 90, 120, 150 and day 180
Method of measurement
Fundoscopy and blood pressure
2
Description
EEG will be performed at day 0, 14, 42, 60, 90 and 180. Sleep EEG will be recorded for a minimum duration of 30 minutes according to international 10-20 system of electrode placement.
Timepoint
day 0, 14, 42, 60, 90 and 180
Method of measurement
Burden of Amplitudes and Epileptiform Discharges (BASED) scoring system
3
Description
Developmental assessment
Timepoint
day 0, 90 and 180
Method of measurement
portage early education program (PEEP)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Children will be divided into two groups by random allocation for the selection of treatment protocol. Group A children will receive prednisolone 40 mg/day in 4 divided doses along with an antacid, increased to 60 mg/day at day 8, if spasm present. Symptomatic and supportive treatment will be provided simultaneously to both groups. All children will be physically followed at day 4, 7, 14, 21, 28, 42, 60, 90,120, 150 and 180 for efficacy and adverse drug reactions. Parents/ caregivers will be trained to maintain and complete a seizure diary including the detail of spasms (number, duration of spasm).
Category
Other
2
Description
Intervention group 2: Group B children will receive vigabatrin plus prednisolone (same protocol as of group A). Vigabatrin will be started with 50 mg/kg/day on day 1 increased to 100 mg/kg/day in two divided doses on day 2 for next three days followed by further increment to 150 mg/kg/day on day 5, if still spasm present. Symptomatic and supportive treatment will be provided simultaneously to both groups. All children will be physically followed at day 4, 7, 14, 21, 28, 42, 60, 90,120, 150 and 180 for efficacy and adverse drug reactions. Parents/ caregivers will be trained to maintain and complete a seizure diary including the detail of spasms (number, duration of spasm). They will also advised and trained to record any event that might be adverse reactions of vigabatrin or prednisolone.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
The Children's Hospital & the Institute of Child Health, Multan.