Rajiv Gandhi University of Health Sciences, Bangalore, Karnataka s9

SYNOPSIS Rajiv Gandhi University of Health Sciences, Bangalore,

Karnataka.

“EEG PROFILE OF NEONATAL SEIZURES”

Name of the candidate : Dr. Megha Raghavan

Guide : Dr. K Varadaraj Shenoy

Course and Subject : M.D. (Paediatrics)

Department of Paediatrics,

Father Muller Medical College,

Kankanady, Mangalore – 575002 November -2013

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,

BANGALORE, KARNATAKA

ANNEXURE II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR

DISSERTATION

1. Name of the candidate and DR. MEGHA RAGHAVAN

address (in block letters) POST GRADUATE RESIDENT,(MD)

DEPARTMENT OF PAEDIATRICS,

FATHER MULLER MEDICAL

COLLEGE,

MANGALORE-575002

2. Name of the Institution FATHER MULLER MEDICAL

COLLEGE MANGALORE -575002

3. Course of study and Subject MD (PAEDIATRICS) 4. Date of admission to course 31-05-2013 5. TITLE OF THE TOPIC

“ EEG PROFILE OF NEONATAL SEIZURES” 6. BRIEF RESUME OF THE INTENDED WORK:

6.1 NEED FOR STUDY :

Neonatal seizures are usually an important indicator of neuronal compromise of the

developing brain and are very common in the first few weeks of life.1 High degree of

clinical acumen is needed in detection of neonatal seizures for they have different

presentations ranging from the subtle to the full-blown tonic clonic variety. This may at

times lead to the varied estimation of seizure occurrence and therefore exact incidence of

neonatal seizures is difficult to define.2

Seizures are often the first sign of neurological dysfunction but their clinical expression at

this age is quite variable, poorly organized and subtle. Electroencephalogram (EEG),

which is valuable for assessing seizures in adults and older children, is yet to gain

importance in the care of sick newborn babies.3 It has the potential to assess severity of

brain dysfunction and aid in discovering subclinical seizures while at the same time

giving us an insight into the various degrees of cerebral maturation.4

The neonatal period encompasses a unique pathophysiology of intense physiological

synaptic excitability.5 Awareness of the limits of normality in this age group enhances the

predictive value of the EEG in this age group. Clinical assessment alone may lead to

significant errors of underestimation or overestimation of seizures and incorporation of

EEG would provide a better foundation to understanding the characterization, description

and classification of these events.6

The heterogeneity of seizure presentation and the understanding of neonatal EEG are of paramount importance.7 In the current study, we aim to describe this association and provide valid evidence in regards to the ability of EEG to confirm or disprove the diagnosis of epileptic nature of a seizure manifestation along with the relevant etiology.

There is a relative dearth of such studies in Indian literature and it is in order to broaden our understanding of this subject that we are undertaking this study.

6.2 REVIEW OF LITERATURE:

Nunes and associates1 from their study of the neurological outcome of newborns with seizures described EEG changes wherein 3.5 % of the newborns showed dysmaturity,

21% with basal rhythm abnormalities, 4% with ictal discharges, and 53% with a combination of two or more abnormalities. They also concluded that out of the neonates with seizures that did not undergo an EEG 70% were in a high-risk situation.

Kumar and his contemporaries2 in their study evaluating the clinical and causal profile of neonatal seizures along with EEG concluded that the incidence of neonatal seizures seems to be more in preterm/LBW babies with perinatal asphyxia responsible for 44.44% of the neonatal seizures.

Cilio Maria3 understood the importance of EEG in the newborn and described technique, prognostic value and the effect of drugs on neonatal EEG concluding that it remains the only neurodiagnostic procedure that provides a valuable assessment of cerebral functioning.

Cherian and co-workers4 have elaborated systematically the technical standards for recording and interpretation of neonatal electroencephalogram and the description of normal as well as abnormal EEG phenomena in terms of discontinuity patterns, spontaneous activity transients, sleep-wake cycles, asymmetry and asynchrony.

Cochrane Review7 describing the anticonvulsants for neonates with seizures discuss the differences in the severity of treated seizures between studies, the fact that etiology of the seizure rather than anticonvulsant therapy may have a greater bearing on the outcome and that future studies must use EEG or at the very least amplitude-integrated EEG criteria and should not rely on clinical seizure detection alone.

Tekgul and his associates8 delineated the etiologic profile and found that global cerebral hypoxia, cerebral hypoxia-ischemia and intracranial hemorrhage were most common.

The relationship between EEG interictal background activity was evaluated for each etiologic class separately and was statistically significant for global HI (83% poor outcome).

6.3 OBJECTIVES OF STUDY: 1. To record the pattern of EEG abnormalities in clinically identified seizures in term

and preterm neonates

2. To correlate the EEG pattern of neonatal seizure with the etiology of the seizure 7. MATERIAL AND METHODS:

7.1 SOURCE OF DATA :

Term and preterm babies with clinically identified seizures occurring within the first 28

days of life.

The study will be done in the neonatal intensive care unit of Father Muller Medical

College for period of 1 year 6 months starting from September 2013.

7.2 METHOD OF COLLECTION OF DATA:

Study Design: This is a descriptive analytical study

Study Duration: 1 year 6 months starting from November 2013

Sample Size: 50 neonates using purposive sampling technique

Inclusion Criteria: Term and preterm neonates showing the first sign of clinical seizure

activity occurring within the first 28 days of life and admitted to the NICU of Father

Muller Hospital

All types of motor and behavioral seizures as per Volpe’s Classification will be

considered.9

Exclusion Criteria:

 Neonates with multiple congenital anomalies or scalp swelling.

 Critically ill neonates on ventilator.  A neonate too sick to be subjected to EEG examination or whenever consent has

not been obtained.

Methodology:

All preterm and term neonates admitted to the NICU of the hospital with clinically identified seizures will be enrolled in the study. At the time of enrolment, an informed written consent would be obtained from the parents. For each recruited baby, the resident

NICU doctor will document the accurate description of the clinical seizure. Relevant data would be entered into a proforma. All investigations for the delineation of etiology of seizure will be performed according to the particular clinical situation. The type of medications/sedation given, including doses used will be included. The EEG recording will be done as early as possible after the subsidence of seizures with hemodynamically stable parameters.

All EEG Studies will be recorded (in the Neurophysiology department) using a digital

EEG Machine (Nihon Kohden - Neurofax µ EEG-9200K). The 10/20 international system of electrode placement with both bipolar and referential electrode montages, recording through 16 channels for a minimum duration of 45 minutes involving 2 sleep cycle states will be used. EEG recordings will be done as per the specifications of

The American Clinical Neurophysiology Society.(11)

EEG will be considered abnormal when it shows slow waves, positive central and temporal sharp waves, repetitive spike discharge, slow delta discharge, burst suppression pattern and other such abnormalities will be outlined subsequently. The EEG will be reviewed by the neurologist who will be blinded to the neonatal clinical status.

STATISTICAL ANALYSIS:

Collected Data will be analyzed by frequency, percentage, chi-square test, sensitivity and

specificity by Kappa statistics.

7.3 Does study require any investigations or interventions to be conducted on

patients or other human or animals? If so please describe briefly.

YES. Term and preterm neonates will undergo EEG recording as per routine

neurological protocol of Father Muller Medical College Hospital.

7.4 Has the ethical clearance been obtained from your institution in case of

7.3? Yes.

8. LIST OF REFERENCES:

1. Nunes ML, Martins MP, Barea BM, Wainberg RC, Costa JC. Neurological outcome of

newborns with neonatal seizures : a cohort study in a tertiary university hospital. Arq

Neuropsiquiatr. 2008 June;66(2A):168-74.

2. Kumar A, Gupta A, Talukdar B. Clinico-Etiological and EEG Profile of neonatal

seizures. Indian J Pediatr. 2007 Jan;74(1):33–7.

3. Cilio MR. EEG and the newborn. Journal of Pediatric Neurology. 2009;7:25–43.

4. Cherian PJ, Swarte RM, Visser GH. Technical standards for recording and

interpretation of neonatal electroencephalogram in clinical practice. Ann Indian Acad Neurol.2009 Jan-Mar;12(1):58–70.

5. Silverstein FS, Jensen FE. Neonatal seizures. Ann Neurol. 2007 Aug;62(2):112–20.

6. Wical BS. Neonatal seizures and electrographic analysis: evaluation and outcomes.

Pediatr Neurol. 1994 Jun;10(4):271-5.

7. Booth D, Evans DJ. Anticonvulsants for neonates with seizures. Cochrane Database of

Systematic Reviews [Internet] 2004 [cited 2004 Mar 29]. Available from: http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD004218.pub2/pdf/standard

8. Tekgul H, Gauvreau K, Soul J, Murphy L, Robertson R, Stewart J, Volpe J, Bourgeois

B, du Plessis AJ. The current etiologic profile and neurodevelopmental outcome of seizures in term newborn infants. Pediatrics. 2006 Apr;117(4):1270–80.

9. Volpe JJ. Neurology of the Newborn. 4th ed. Philadelphia: WB Saunders; 2001.

Chapter 5, Neonatal seizures; p.178-214.

10. Shellhaas RA, Chang T, Tsuchida T, Scher M, Riviello JJ, Abend NS, Nguyen S,

Wusthoff CJ, Clancy RR. The American Clinical Neurophysiology Society’s Guideline on Continuous Electroencephalography Monitoring in Neonates. J Clin Neurophysiol.

2011 Dec;28(6):611-7.

11. Etrebi MA, El-samie HA, Awad M. Role of Interictal Neonatal electroencephalogram in diagnosis and prognosis of recurrent neonatal seizures. Egypt J Neurol Psychiat

Neurosurg [Internet]. 2007 [cited 2007 Jan];44(1):177-191. Available from: http://www.ejnpn.org/Article/ShowFullText.aspx?Id=126 9. SIGNATURE OF THE CANDIDATE:

10. REMARKS OF THE GUIDE: There is only 1 study from

India dealing with this

particular topic. Hence , this is

an attempt to further our

understanding.

11. Name & Designation of :

11.1 Guide Dr. K. VARADARAJ SHENOY Professor, Department of Paediatrics

11.2 Signature

11.3 Head of Department Dr. PAVAN HEGDE Professor and HOD Department of Paediatrics

11.6 Signature 12. 12.1 Remarks of the chairman & principal:

12.2 Signature