Dr Mohammed Ashfaque Md Ashraf Tinmaswala Junior resident, Department of Pediatrics Grant medical college Mumbai- 400008 Date: 07.01.

13 To, The chairman, Institutional Ethical committee, Grant Medical College, Mumbai- 400008 Through proper channel Subject:- Application for approval of dissertation topic by ethical committee. Respected Sir, I hereby propose to do dissertation in the topic titled Role of electroencephalogram and neuroimaging in first onset afebrile and complex febrile seizures in children in a tertiary care hospital under the guidance of Dr Subhash k Valinjker Associate professor, department of pediatrics. I request you to kindly sanction approval to pursue this study. Please find enclosed herewith the following documents. 1) General information. 2) Synopsis of the study. Thanking you in anicipation. Yours faithfully

Dr Mohammed Ashfaque Md Ashraf Tinmaswala Herewith forwarding the application of Dr Mohammed Ashfaque md Ashraf tinmaswala for approval of dissertational research work. The research work fulfills all the criteria laid down by the ethical committee. So I strongly recommend this topic for approval of the committee.

Dr subhash k. Valinjkar Post Graduate Guide Associate professor Department of Paediatrics Grant Medical college Mumbai

SYNOPSIS Part I General Information Title : Role of electroencephalogram and neuroimaging in first onset afebrile and complex febrile seizures in children in a tertiary care hospital 1) Name and designation of Post Graduate student : Dr Mohammed Ashfaque Tinmaswala Junior Resident Dept Of paediatrics Grant Medical College Mumbai. 2) Post Graduate Guide : Dr subhash k. Valinjkar Associate professor Department of Paediatrics Grant Medical College Mumbai 3) Duration of research activities : 15 months (August 2013 to December 2014 )

a) Deadline for collection of date b) Period that may be required for analyzing the date c) Deadline for submission of dissertation to the University 4) Signatures

: :

August 2014 3 Months

Dec 2014

PG Student

PG Guide

Head of the Department

5) Date of submission to ethical committee 6) Date of clearance by ethical committee 7) Remarks by the chairman of ethical committee

: : :

Department

Paediatrics

Candidates Academic Year

2013

Course and Subject

M.D Paediatrics

College Name and Address

Grant Government Medical College mumbai

Reference Number To,

date:-

Dr Mohammed Ashfaque Tinmaswala Department of paediatrics Grant Government Medical college, Mumbai- 400008 Subject:- Regarding Your research proposal of dissertation topic titled Role of electroencephalogram and neuroimaging in first onset afebrile and complex febrile seizures in children in a tertiary care hospital

Ref :- __________________________________________________________

Dear Student, The abovementioned research proposal of dissertation topic was discussed in the ethical committee meeting held on ________________ at our college. Ethical committee has unanimously approved your dissertation topic. This work will be done under the guidance and supervision of your guide Dr. Subhash K.Valinjker. (Signature)

Chairperson , Ethical Committee Grant Government Medical college Mumbai

Name of the college

Grant Government Medical college Mumbai

Department Name of the Guide Contact Number of Guide

Paediatrics Dr. Subhash K. valinjkar 09967870480

Through Proper Channel

To, The Registrar, Maharashtra University of health sciences Nashik-422004 Sub.: Submission of Title & Synopsis of Dissertation Respected Sir/Madam I , Dr Mohammed Ashfaque Md Ashraf Tinmaswala, am registered for MD in paediatrics of 2013-2014 batch under the guidance of Dr subhash K.Valinjkar , Associate professor, Dept of paediatrics, G.M.C & sir J.J Group of hospitals, Byculla, Mumbai. I am due to appear for MD Paediatrics examination in 2015. I am submitting herewith Title & Synopsis of Dissertation as mentioned below & as suggested by my aforesaid Guide. Topic: Role of electroencephalogram and neuroimaging in first onset afebrile and complex febrile seizures in children in a tertiary care hospital Kindly accept and register my Title of Synopsis.

Dr.Mohammed Ashfaque Tinmaswala (Candidates Name and signature) The qualification of the teacher is recognised by the Central Council

Dr. Subhash K.Valinjker (Guides name and signature)

Dr Ashok D Rathod (H.O.Ds Name and signature with the seal of the department)

(Signature and the seal of the Dean of the college)

 Role of electroencephalogram and neuroimaging in first onset afebrile and complex febrile seizures in children in a tertiary care hospital

INTRODUCTION

Seizures are the most common pediatric neurological disorder with 4% to 10% of children suffering at least one seizure in the first 16 year of their life [1]. Epidemiological studies reveal that approximately 1,50,000 children will sustain a first-time, unprovoked seizure each year and of these 30,000 will develop epilepsy.

EEG and neuroimaging are vital to the management of epilepsy. EEG is recommended as a part of the neurodiagnostic evaluation of the child with an apparent unprovoked seizure[2,3]. Well appearing children who have experienced a first-time afebrile seizure should be referred for outpatient EEG testing[4,5]. It is important to note that a normal EEG does not rule out epilepsy or other underlying neurologic disorder but an abnormal EEG increases the chances of later development of epilepsy[6].

EEG and neuroimaging are generally not recommended in first onset simple febrile seizures if the child is otherwise neurologically healthy[7]. But the workup of children with complex febrile seizures needs to be individualized. This can include EEG and neuroimaging particularly if the child is neurologically abnormal. Patients with febrile status epilepticus have been reported to be having swelling in their hippocampus acutely and subsequently long term hippocampal atrophy is also seen on neuroimaging of these children.

With that brief introduction its also a well known fact that as a pediatrician many are perplexed with the extent one needs to go for investigating these children who present with first onset afebrile and complex febrile seizures. The role of neuroimaging in children with new onset afebrile seizures/ unprovoked seizures is not well defined [8,9] insufficient evidence is available to make a standard recommendation or guidelines for the use of routine neuroimaging in children with first unprovoked seizure. In contrast guidelines for obtaining neuroimaging in adult patients presenting with seizures have been published [8,9].

In a few studies that have reviewed the yield of neuroimaging in children with unprovoked seizure, the prevalence of abnormalities ranged from 0% to 21%.[10-12] Although there is ample investigation and data concerning initial management, treatment approaches, and outcomes in children with simple febrile seizures, there is somewhat less well-developed data on Complex Febrile Seizures (CFS).

AIMS AND OBJECTIVES

(1) To determine the frequency of abnormal Electroencephalogram and neuroimaging in children with newonset afebrile and complex febrile seizures.

(2) To draw a correlation between Electroencephalogram (EEG) and neuroimaging in the children with new onset afebrile and complex febrile seizures.

MATERIALS AND METHODS

This is a prospective, stratified-randomized cohort study conducted on children in the age group of 6 months to 14 years having first-onset unprovoked seizures and Complex Febrile Seizures. The patients attending the Emergency, in-patient and outpatient Departments of Paediatrics Division of this institute from august 2013 to august 2014, were enrolled for the study as per the criteria given. It was a prospective, stratified-randomized cohort study conducted on children in the age group of 6 months to 14 years having first-onset unprovoked seizures and CFS.Children were excluded from the study if the seizure resulted from an acute situational etiology such as toxin or trauma. They were also excluded if they had a chronic neurologic illness limiting their activities of daily living, such as cerebral palsy, mental retardation, and pervasive development disorders, or had other abnormalities on neurologic examination or had simple febrile seizure. The study was approved by the Institutional ethical committee. Parents of the patients signed consent forms before participation. A detailed clinical and developmental history was taken and physical and neurological examination was carried out.Blood samples of all subjects were drawn on admission and routine laboratory studies were performed. Complete blood counts, blood sugar, serum Na+, K+, calcium were analyzed in order to exclude possible metabolic disorder, and to identify a predominant seizure type and potential epilepsy syndrome. The International League Against Epilepsy classification was used to define seizure types. An EEG was performed in all the subjects in the study. EEG was performed within 2 weeks of the first unprovoked epileptic seizure. The EEG was analyzed by a clinical neurologist from the Department of Neurology of this institute Computed tomography (CT) scan of head was performed in all the subjects. Cranial MRI was performed on patients who had focal findings in their EEGs and in those where CT findings needed further characterization. MRI was performed andNeuroimaging CT/MRI reports were categorized as normal and abnormal. A CT Scan and an MRI was done and the abnormality reported in these neuroimaging techniques was correlated with abnormal electroencephalogram findings.

Inclusion criteria:All pediatric patient of age group 6months to 14 years who presented with either first onset afebrile seizures or first onset complex partial seizures.

Exclusion criteria:1) Patients with simple febrile convulsions. 2) If the seizures are casued by an acute situational etiology such as toxin or trauma.

3) Patients with a chronic neurological illness limiting their activities of daily living such as cerebral palsy, mental retardation, and pervasive developmental disorder.

Time period of the study:

August 2013 to December 2014

ANNEXURE I PROFORMA Name : Age /Sex : Address : D.O.A : PRESENTING COMPLAINTS : History : Symptoms : 1) Convulsions 2) Type of convulsions 3) Altered sensorium 4) Fever 5) Cough 6) Cold 7) Headache 8) Vomiting 9) Lethargy Duration : 10) Irritability 11) Photophobia 12) Neck stiffness 13) Ear discharge 14) Loose stools 15) Symptoms of C.Nnerve palsy 16) Abnormal behaviour 17) Drug intake 18) Burning Micturation Duration : D.O.D I.P. No. :

Past history : 1) History of convulsions or Antiepileptic drug intake Family history : 1) Similar illness 2) Contact with TB IMMUNIZATION : BCG : DPT : Any other immunisation DEVELOPMENTAL HISTORY : BCG scar : B1 Present / Absent : B2

C) Anthropometry : HC Nutritional status : a) Normal b) MAM c) SAM PHYSICAL EXAMINATION : A) Posture : B) Vitals : HR RR TEMP BP D) Head : Head circumference Shape Fontanel Nature of sutures Signs of raised ICT

CC

MAC

HT

WT

Socio-economic status :

Signs of hydrocephalus. E) Eyes : Pallor Phlycten F) Ear : G) Nose : H) Oral cavity : I) Neck : Swelling : Sinuses : Skin : Rashes : Signs of dehydration : J) Chest and abdomen : K) Lymph Nodes : L) Bones and joints : Gibbus : Iatrogenic procedures : Miscellaneous : Choroid tubercles Fundus

Signs of osteomyelitis : SYSTEMIC EXAMINATION : Central nervous system : A) Higher function Consciousness Orientation Speech B) Cranial nerve : 3 6 4 7

Any other cranial nerve involvement C) Motor system : i) Posture iii) Power UL LL iv) Abnormal movements v) Reflexes : Rt. a) Superficial Abdominal Cremasteric Plantar b) Deep Biceps Triceps Supinator Knee Ankle Clonus * Ankle * Knee vi) Cerebellar signs : vii) Gait : viii) Sensory system : ix) Meningeal signs : Lt. ii) Tone: Rt. Hypo / Hyper Lt.

x) Spine and skull :

RESPIRATORY SYSTEM : CARDIOVASCULAR SYSTEM : PER ABDOMEN : INVESTIGATIONS A) 1) Haemoglobin gm% : 2) Total leukocyte count : 3) Differential leukocyte count : 4) ESR : 5) Mantoux test : 6) Blood glucose : 7) Serum calcium : 8) Serum electrolytes : B) Fundoscopy : C) Lumbar puncture : Macroscopy : Tension : Fluid : On standing : Biochemistry : Sugar (mg/dl) Proteins (mg/dl) Chlorides (mEq/l) Cytopathology : Cell type Cell count Gram and ZN staining Culture and sensitivity Normal / Increased Clear / Turbid Cobweb N: L: Platelet count : E: M:

D) EEG Findings :

CT scan (P+C)

CT scan findings : a) Hydrocephalus : (mild, moderate, severe) ventricular index b) Basal exudates (mild, moderate, severe) d) Tuberculoma Supra tentorial Infra tentorial Peri lesional oedema e) Any other finding Size : No. :

E) MRI Findings:

F) Other investigations :

Bibliography

[1] McAbee GN, Wark JE. A practical approach to uncomplicated seizures in children. Am Fam Physician 2000;62(5):1109 16 [2]. Pohlmann-Eden B, Beghi E, Camfield C, Camfield P. The first seizure and its management in adults and children. BMJ 2006;332:339-42. [3] Hirtz D, Ashwal S, Berg A, Bettis D, Camfield C, Camfield P, et al.Practice parameter: Evaluating a first nonfebrile seizure in children: Report of the quality standards subcommittee of the American Academy of Neurology, the Child Neurology Society, and the American Epilepsy Society. Neurology 2000;55:616-23. [4] Shneker BF, Fountain NB. Epilepsy. Dis Mon 2003;49:426 78. [5] Reuter D, Brownstein D. Common emergent pediatric neurologic problems. Emerg Med Clin North Am 2002;20(1):155 76 [6] Scheuer ML, Pedley TA. The evaluation and treatment of seizures. N Engl J Med 1990;323:1468 74 [7] Mohamad A. Mikati Nelson T extbook of Pediatrics, 19 editioc 7266 [8] Camfield PR, Camfield CS, Dooley JM, Tibbles JA, Fung T, Garner B. Epilepsy after a first unprovoked seizure in childhood. Neurology 1985;35:1657-60. [9] Sharma S, Riviello JJ, Harper MB, Baskin MN. The role of emergent neuroimaging in children with newonset afebrile seizures. Pediatrics 2003;111:1-5 [10] Schoenenberger RA, Heim SM. Indication for computed tomography for brain in patients with first uncomplicated generalized seizure. BMJ 1994;309:986-9. [11] Ramirez-Lassepas M, Cipolle RJ, Morillo LR, Gumnit RJ. Rate of computed tomographic scan in the evaluation of adult patients after their first seizure. Ann Neurol 1984;15:536-43. [12] Simone CV, Paulo Breno NL, Monica JS, Adriana BO, Alaides SFO, Alfredo LJ.First unprovoked seizure: Clinical and electrographic aspects. J Epilepsy Clin Neurophysiol 2006;12:69-72