EFFECT OF LACOSAMIDE ON BEHAVIOUR OF CHILDREN WITH REFRACTORY PARTIAL EPILEPSY

Objective: A unicentre, prospective study was carried out to investigate the behavioral effects of lacosamide as adjunctive therapy with refractory partial epileptic children in tertiary care hospital with prior approval from the Institutional Human Ethical Committee. Methods: Seventy nine patients (age 5- 15 years) with refractory partial epilepsy patients were enrolled after fulfilling the inclusion and exclusion criteria. And those who had failed ≥ 2 antiepileptic drugs in whom lacosamide was added as add on drug therapy. Lacosamide tablets was administered orally twice daily. Influence of Lacosamide on children's behaviour was performed at every visit of titration, maintenance period and 2 follow ups at monthly interval. Patient's caregiver or investigator observed adverse events were recorded. Results: Out of 79 patient's, 53 were males and 26 females. Patients completing 3 months, of study therapy showed significant (p<0.001) decrease in frequency of seizure and improvement in behaviour at end of the treatment period and few patients had mild transient adverse events. Three patients were dropped from the study. Conclusion: Lacosamide signifies a beneficial drug that is effective and concurrently improved patient's behaviour in refractory partial epilepsy paediatric patients

Study of serum vitamin B12 levels in pregnant mothers and their newborns and its relation to growth of the infants

Introduction: The effect of vitamin B12 deficiency in pregnancy on the growth of infants has not been properly studied. Objectives: To study the correlation of vitamin B12 levels in pregnant mothers with vitamin B12 levels in their newborn infants and to know it’s relation to the growth of infants. Materials and Methods: Hundred full-term pregnant women and their newborns were enrolled from January 2011 to January 2012. Vitamin B12 levels were assessed and the growth of infants monitored till 6 months of age. Results: A total of 60 pregnant women (60%) had vitamin B12 deficiency while 29 newborns (29%) had low vitamin B12 levels. Vitamin B12 levels in the newborns had a strong positive correlation with mothers’ vitamin B12 levels (r=0.56; p<0.05). Babies born to vitamin B12 deficient mothers were shorter, and their mean weight at 6-month of age was significantly less. Conclusion: Vitamin B12 deficiency is very common in Indian pregnant mothers; it leads to vitamin B12 deficiency and growth retardation in their babies

The impact of DocosaHexaenoic Acid supplementation during pregnancy and lactation on Neurodevelopment of the offspring in India (DHANI): trial protocol.

BACKGROUND: Evidence suggests a strong association between nutrition during the first 1000 days (conception to 2 years of life) and cognitive development. Maternal docosahexaenoic acid (DHA) supplementation has been suggested to be linked with cognitive development of their offspring. DHA is a structural component of human brain and retina, and can be derived from marine algae, fatty fish and marine oils. Since Indian diets are largely devoid of such products, plasma DHA levels are low. We are testing the effect of pre- and post-natal DHA maternal supplementation in India on infant motor and mental development, anthropometry and morbidity patterns. METHODS: DHANI is a double-blinded, parallel group, randomized, placebo controlled trial supplementing 957 pregnant women aged 18-35 years from ≤20 weeks gestation through 6 months postpartum with 400 mg/d algal-derived DHA or placebo. Data on the participant's socio-demographic profile, anthropometric measurements and dietary intake are being recorded at baseline. The mother-infant dyads are followed through age 12 months. The primary outcome variable is infant motor and mental development quotient at 12 months of age evaluated by Development Assessment Scale in Indian Infants (DASII). Secondary outcomes are gestational age, APGAR scores, and infant anthropometry. Biochemical indices (blood and breast-milk) from mother-child dyads are being collected to estimate changes in DHA levels in response to supplementation. All analyses will follow the intent-to-treat principle. Two-sample t test will be used to test unadjusted difference in mean DASII score between placebo and DHA group. Adjusted analyses will be performed using multiple linear regression. DISCUSSION: Implications for maternal and child health and nutrition in India: DHANI is the first large pre- and post-natal maternal dietary supplementation trial in India. If the trial finds substantial benefit, it can serve as a learning to scale up the DHA intervention in the country. TRIAL REGISTRATION: The trial is retrospectively registered at clinicaltrials.gov ( NCT01580345 , NCT03072277 ) and ctri.nic.in ( CTRI/2013/04/003540 , CTRI/2017/08/009296 )

Safety of lacosamide in children with refractory partial epilepsy

AbstractObjectives: The study was carried out to investigate the safety of lacosamide on children with refractory partial epilepsy. Materials & methods: The study was carried out at a tertiary care hospital after obtaining approval from the institutional ethics committee. Patients aged between 5 and 15years taking oral lacosamide (LCM) tablets that were given orally as an adjunctive anti-epileptic drug were enrolled for assessing safety, tolerability and its effect on the behavioural life at every visit of titration, during the treatment period (3months) and at 2 follow up visits that were done at monthly intervals. Adverse events reported by caregiver or by investigator were recorded. Patients/caregivers also completed a 25 items on Connor’s behavioural rating clinical scale at every visit. Results: Out of 531 screened patients, 79 patients with refractory partial epilepsy were enrolled after they fulfilled the inclusion and exclusion criteria. Mean age of the children was 8.84±3.09years (5–15years), of which 53 were males and 26 females. The mean age at onset of seizures in males was 6.46±3.57 and in females, 6.38±3.39years. Seventy-six children of 79, completed 3months of treatment period showed significant (p<0.001) decrease in the frequency of seizures, significant improvement in behaviour and showed good tolerability. Three (3.79%) patients dropped out of the study due to hyperactive behaviour, vomiting and lack of seizure control respectively. Conclusions: Lacosamide is a well-tolerated newer antiepileptic drug that is effective in refractory partial epilepsy paediatric patients and concurrently improved patient’s behaviour

Attention-deficit hyperactivity disorder in children with idiopathic epilepsy: A cross-sectional study

Aim: This study sought to determine the prevalence and characteristics of Attention Deficit Hyperactivity Disorder (ADHD) in children with idiopathic epilepsy (CWE). Methodology: Purposive sampling was done to select 94 children with idiopathic epilepsy. These children were administered the Abbreviated Conners Scale to screen for ADHD, which was then confirmed using DSM 5 diagnostic criteria. Results: 23.4% of CWE were found to have comorbid ADHD, compared to 3-5% in the general population. The characteristics of ADHD also differed in our sample as compared to the general population. Conclusion: The findings of our study can help make diagnosticians more astute to identify ADHD in CWE