Influence of gestational age on eruption of primary teeth in Indian children - A prospective longitudinal study.

Context: Eruption of primary teeth is the most anticipated event in a child's life. Genetics, gender, socio-economic status, gestational age are a few of the determinants of the primary teeth eruption. However, the effect of gestational age on the timing of primary teeth eruption among the Indian population has not been explored to date. Aim: The study was conducted to evaluate the influence of gestational age on time and sequence of eruption of primary teeth among children of Mysore. Settings and Design: A prospective longitudinal cohort study design was conducted at 'Baby Oral Health Promotion Clinic' at the Department of Paediatrics, JSS Hospital, Mysore. Methods and Material: 150 newborn babies were recruited by simple random sampling and followed up from birth to 36 months. Teeth present during each visit were recorded. Data were statistically analysed and interpreted. Statistical Analysis Used: Descriptive statistics, t-test for an independent sample, and Pearson's Chi-squared test were applied. Results: The mandibular central incisor was the first tooth to erupt. Statistically insignificant early eruption in males was noted in both term and preterm children. When the chronological ages were compared, the preterm group showed a statistically significant delay in the eruption of all the teeth. However, when the age was adjusted for prematurity, only the central incisors and second molars showed a statistically significant delay. Conclusions: Gestational age has a strong significant association with the eruption of primary teeth and maybe one of the strong predictors for delayed eruption among children of Mysore.

Prevalence of overweight and obesity among school children in Mysuru, Karnataka.

Childhood obesity has become a major public health challenge in developing countries including India due to the changes in the lifestyle and food habits of children owing to the influence of urban culture and technological growth. The present study is a cross-sectional, school-based study conducted to assess the prevalence of obesity and to determine the demographic variables influencing the obesity among school children. METHODS: The study included 440 students (Boys: 240, Girls: 200) from two randomly selected schools of Mysuru city, Karnataka. WHO Standard Age and Sex specific Growth Reference charts were used for defining overweight and obesity. Modified Kuppuswamy's socioeconomic scale (2019) was adopted to assess the socioeconomic status of the family. RESULTS: Obesity prevalence among the study subjects was 3.86% and overweight was 12.27%. The mean body mass index (BMI) among boys was 18.13 and girls was 18.80. The difference in the distribution of BMI between male and female groups was statistically significant (P = 0.023). Age and obesity status of the children was found to have a significant association (P = 0.022). Prevalence of overweight and obesity was more among children from higher socioeconomic class (P = 0.01). CONCLUSION: Prevalence of obesity and overweight among school children is comparatively higher. The higher familial income, dietary patterns, parental history of obesity and diabetes and having urban residence were identified as the major factors which influenced the obesity status of the school children.

The Spectrum of Congenital Central Nervous System Anomalies Among Stillborn: An Autopsy Based Study.

BACKGROUND: Congenital central nervous system (CNS) anomalies are the structural or functional abnormalities of the brain and spinal cord that occur during the intrauterine developmental process. PURPOSE: The present study aims to detect the prevalence of congenital CNS anomalies among stillborn fetuses, the association between congenital anomalies and maternal factors, and also the association between autopsy and ultrasound findings. METHODS: This study was conducted on 50 stillborn fetuses, obtained from the Department of Obstetrics and Gynecology at JSS Medical College and Hospital, Mysuru. The fetuses were fixed in 10% formalin and autopsies were performed as per the standard fetal autopsy protocol. The congenital CNS anomalies were studied in detail. RESULTS: CNS anomalies were the most common congenital anomalies observed. Out of the total 50 stillborn fetuses studied, CNS anomalies were found in 17 fetuses and their occurrence was more common among male stillborn than females. Meningomyelocele was the most common anomaly, followed by anencephaly. The other anomalies documented were meningocele, encephalocele, meningoencephalocele, agenesis of the corpus callosum, craniorachischisis, bifid cerebellum with hypoplastic vermis, holoprosencephaly, and sirenomelia.Fisher's exact test showed a significant association between maternal hypothyroidism and congenital CNS anomalies (P < .05). The autopsy confirmed the ultrasound findings in 40 (80%) fetuses. There were significant additional findings observed in seven (14%) fetal autopsies and ultrasound diagnosis completely changed in three (6%) cases, after the final autopsy procedure. CONCLUSION: The fetal autopsy is the single most directly evident investigation, which gives information that changes or significantly improves the clinical diagnosis. A multidisciplinary holistic approach toward pregnancy will help to detect any kind of abnormality in the fetus and thus to take a timely decision toward the management.

A cross-sectional study on eruption timing of primary teeth in children of Mysore, Karnataka.

CONTEXT: Eruption of first primary teeth is the most anxiously awaited developmental milestone in a child. However, primary teeth have shown wide variations in their eruption time among different population, ethnic, and racial groups. AIMS: The present study was conducted with the aim to evaluate the time and sequence of eruption of primary teeth of children of Mysore. SETTINGS AND DESIGN: A cross-sectional study design included 1392 participants aged 3 months to 36 months recruited by simple random sampling method. The variables such as age, gender, and number of erupted primary teeth were recorded. SUBJECTS AND METHODS: Clinical examination was done under natural illumination. A tooth was considered erupted when any part of its crown had penetrated the gingiva and was visible in the oral cavity. STATISTICAL ANALYSIS USED: Probit regression analysis was performed to obtain the mean and median age of eruption of teeth. The significance of difference in the mean age of eruption across gender and arch was determined using paired t-test. RESULTS AND CONCLUSION: The first primary tooth to erupt was mandibular central incisor at 10.24 ± 2.47 months followed by maxillary central incisor at 11.06 ± 2.65 months. The duration of primary teeth eruption was 17.89 and 18.32 months in males, 18.54 months and 18.32 months in females for maxilla and mandible, respectively. Eruption of primary tooth is delayed among children of Mysore as compared to standard eruption chart. The results will provide information to health professional about contemporary tooth eruption time derived from an Indian population.

A Phase III open-label, randomized, active controlled clinical study to assess safety, immunogenicity and lot-to-lot consistency of a bovine-human reassortant pentavalent rotavirus vaccine in Indian infants.

BACKGROUND: A heat-stable bovine-human rotavirus reassortant pentavalent vaccine (BRV-PV, ROTASIIL®) was developed in India. In this study, the vaccine was tested for safety, immunogenicity and clinical lot-to-lot consistency. METHODS: This was a Phase III, open label, randomized, equivalence design study. The primary objective was to demonstrate lot-to-lot consistency of BRV-PV. Subjects were randomized into four arms, three arms received Lots A, B, and C of BRV-PV and the control arm, received Rotarix®. Three doses of BRV-PV or two doses of Rotarix® and one dose of placebo were given at 6, 10, and 14 weeks of age. Blood samples were collected four weeks after the third dose to assess rotavirus IgA antibody levels. The three lots of BRV-PV were equivalent if the 95% Confidence Intervals (CIs) of the geometric mean concentration (GMC) ratios were between 0.5 and 2. Solicited reactions were collected by using diary cards. RESULTS: The study was conducted in 1500 randomized infants, of which 1341 infants completed the study. The IgA GMC ratios among the three lots were around 1 (Lot A versus Lot B: 1.07; Lot A versus Lot C: 1.06; and Lot B versus Lot C: 0.99). The 95% CIs for the GMC ratios were between 0.78 and 1.36. The IgA GMCs were: BRV-PV group 19.16 (95% CI 17.37-21.14) and Rotarix® group 10.92 (95% CI 9.36-12.74) (GMC ratio 1.75; 90% CI 1.51-2.04). Seropositivity rates were 46.98% (95% CI 43.86-50.11) and 31.12% (95% CI 26.17-36.41). The incidence of solicited reactions was comparable across the four arms. No serious adverse events were associated with the study vaccines, except two gastroenteritis events in the BRV-PV groups. CONCLUSION: Lot-to-lot consistency of BRV-PV was demonstrated in terms of GMC ratios of IgA antibodies. The vaccine safety and immunogenicity profiles were similar to those of Rotarix®. Clinical Trials.Gov [NCT02584816] and Clinical Trial Registry of India [CTRI/2015/07/006034].

Non-interference of Bovine-Human reassortant pentavalent rotavirus vaccine ROTASIIL® with the immunogenicity of infant vaccines in comparison with a licensed rotavirus vaccine.

BACKGROUND: A newly developed bovine-human reassortant pentavalent vaccine (BRV-PV, ROTASIIL®) was tested for its potential effect on the immunogenicity of concomitantly administered EPI vaccines in infants in a randomized controlled study in India. METHODS: In this Phase III, multicenter, open label, randomized, controlled study, three doses of BRV-PV or two doses of Rotarix® and one dose of placebo were given to healthy infants at 6, 10, and 14 weeks of age. Subjects also received three doses of DTwP-HepB-Hib (diphtheria, tetanus, whole-cell pertussis, hepatitis B, and haemophilus influenzae type b conjugate - pentavalent vaccine) and oral polio vaccine concomitantly at 6, 10, and 14 weeks of age and a single dose of inactivated polio vaccine at 14 weeks of age. Blood samples were collected four weeks after the final vaccination to assess immune responses to all the vaccines administered. For diphtheria, tetanus, hepatitis B, Hib, polio type 1, and polio type 3 antibodies, non-interference was to be supported if the lower limit of the two-sided 90% confidence interval (CI) for the seroprotection rate difference for the BRV-PV group minus the Rotarix® group was >10.0%. For pertussis antibodies, non-interference was to be supported if the lower limit of the two-sided 90% CI for the ratio of geometric mean concentrations (GMCs) was >0.5. RESULTS: A total of 1500 infants were randomized to either BRV-PV (1125 infants) or Rotarix® (375 infants), of which 1341 completed the study as per the protocol. More than 97% of subjects achieved seroprotective antibody titres against diphtheria, tetanus, hepatitis B, Hib, polio type 1, and polio type 3 in both groups. The difference in seroprotection rates between the BRV-PV group and the Rotarix® group for all these antibodies was less than 1%. The ratio of GMCs of anti-pertussis IgG concentrations for the BRV-PV group versus Rotarix® was 1.04 [90% CI: 0.90; 1.19]. CONCLUSION: BRV-PV does not interfere with the immunogenicity of concomitantly administered routine infants vaccines.

Adverse Drug Reactions in Hospitalized Pediatric Patients: A Prospective Observational Study.

OBJECTIVES: To determine the incidence, pattern, causality, preventability, severity and predictors of adverse drug reactions (ADRs) in pediatric population. METHODS: It was a prospective, observational study that included patients of either sex, of any age treated in the pediatric wards of a tertiary care hospital. Study patients were followed throughout their hospital stay. Whenever an ADR was detected, all the required data was collected and analyzed. Data was analyzed for incidence, causality (by using WHO Probability scale and Naranjo's algorithm), preventability (by using Modified Shumock and Thornton scale), severity (by using Modified Hartwig and Siegel scale) and predictors of ADRs. RESULTS: Of the 1775 children admitted in the pediatrics ward, 1082 patients met study criteria and were enrolled into the study. A total of 64 ADRs were identified from 54 patients. The incidence of ADRs was 4.99 %. Male patients experienced majority (68.52 %) of ADRs. Drugs most commonly implicated in ADRs were amoxicillin + clavulanate (21.87 %) followed by ceftriaxone (20.31 %). Most (51.56 %) of the ADRs reported belonged to the system organ class, gastrointestinal system disorders. Among the ADRs reported, 82.85 % of ADRs were mild. Majority (87.5 %) of the ADRs were of 'probable' causality category and 96.9 % were not preventable. There was a significant association between occurrence of ADRs and the use of ≥4 number of medications, age (infants) and gender (male). CONCLUSIONS: Among the pediatric population, infants, male gender and those receiving ≥4 number of medications are at risk of developing ADRs. Constant monitoring is required to address the safety issue in pediatric population especially in infants and patients receiving ≥4 drugs.

Revised IAP growth charts for height, weight and body mass index for 5- to 18-year-old Indian children.

JUSTIFICATION: The need to revise Indian Academy of Pediatrics (IAP) growth charts for 5- to 18-year-old Indian children and adolescents was felt as India is in nutrition transition and previous IAP charts are based on data which are over two decades old. PROCESS: The Growth Chart Committee was formed by IAP in January 2014 to design revised growth charts. Consultative meeting was held in November 2014 in Mumbai. Studies performed on Indian children's growth, nutritional assessment and anthropometry from upper and middle socioeconomic classes in last decade were identified. Committee contacted 13 study groups; total number of children in the age group of 5 to 18 years were 87022 (54086 boys). Data from fourteen cities (Agartala, Ahmadabad, Chandigarh, Chennai, Delhi, Hyderabad, Kochi, Kolkata, Madurai, Mumbai, Mysore, Pune, Raipur and Surat) in India were collated. Data of children with weight for height Z scores >2 SD were removed from analyses. Data on 33148 children (18170 males, 14978 females) were used to construct growth charts using Cole's LMS method. OBJECTIVE: To construct revised IAP growth charts for 5-18 year old Indian children based on collated national data from published studies performed on apparently healthy children and adolescents in the last 10 years. RECOMMENDATIONS: The IAP growth chart committee recommends these revised growth charts for height, weight and body mass index (BMI) for assessment of growth of 5-18 year old Indian children to replace the previous IAP charts; rest of the recommendations for monitoring height and weight remain as per the IAP guidelines published in 2007. To define overweight and obesity in children from 5-18 years of age, adult equivalent of 23 and 27 cut-offs presented in BMI charts may be used. IAP recommends use of WHO standards for growth assessment of children below 5 years of age.

A serial echocardiographic study of myocardial abscess in a patient surviving staphylococcal septicemia.

2D echocardiography was performed on a 4-year-old child suffering from right thigh abscess due to MRSA infection following diagnosis of pericardial effusion by USG abdomen. It revealed myocardial abscess and pericardial effusion. This child underwent series of 2D echocardiographic studies which showed image appearance of myocardial abscess with its time course of healing.

Clinico-bacteriological profile and outcome of empyema.

Empyema thoracis is a common cause of morbidity in children. We conducted a prospective observational study in 50 children (age 0-15 y) diagnosed with empyema to study its clinico-bacteriological profile and outcome in a referral hospital. Staphylococcus aureus was the most common causative organism, most of them being MRSA, followed by Pneumococcus and Pseudomonas. Primary video-assisted thoracoscopy appeared to be a good mode of management with lesser duration of hospital stay. However, the number of children undergoing this procedure was very less, to come to any conclusion.

Prevalence of prehypertension and hypertension among urban and rural school going children.

This school based cross sectional study was done to estimate the prevalence of prehypertension and hypertension among apparently healthy school children in urban and rural Mysore. Prevalence of prehypertension and hypertension was 2.9% and 2.8% in urban children and 2.8% and 2% in rural children with no statistically significant difference between them.

Prevalence of prediabetes in school-going children.

OBJECTIVE: To study the prevalence of prediabetes among school children in Mysore city. DESIGN: Cross sectional study. SETTINGS: Children aged 5-10 years from three schools in Mysore city were included. Study was done over a period of 1 year during 2006-2007. PARTICIPANTS: 726 children (59.8%; males). MAIN OUTCOME: Prevalence of prediabetes. Prediabetes was defined as fasting blood sugar level between 100-125 mg/dL. RESULTS: The prevalence of prediabetes was 3.7%;. No statistically significant association was observed with major risk factors of diabetes. CONCLUSIONS: Efforts must be made to recognize type 2 diabetes in the asymptomatic prediabetes state.

Single-nucleotide polymorphisms of NKX2.5 found in congenital heart disease patients of Mysore, South India.

Congenital heart disease (CHD) is a common congenital birth defect, affecting nearly 1% of all live births, and is the most common cause of infant death. NKX2.5 is an important transcription factor expressed during vertebrate heart development and involved in the regulation of septation during cardiac morphogenesis and in the maturation and maintenance of the atrioventricular node throughout life. There are many reports on association of single-nucleotide polymorphisms (SNPs) of NKX2.5 with CHD but none have been reported from Mysore, South India. With informed consent, 150 clinically diagnosed CHD patients and 70 unrelated healthy controls in Mysore, South India, were recruited. In the first phase the DNAs of 50 CHD patients and 20 controls were subjected to polymerase chain reaction amplification of coding regions of NKX2.5 and further sequenced for SNP genotyping. Additionally, mass array analysis of SNPs was performed for 100 CHD and 50 controls. Analysis revealed the occurrence of six SNPs in different types of CHDs. Two were synonymous SNPs, the most common c.239A>G (p.E21E) and newly identified c.896C>A (p.A240A), as well as three nonsynonymous SNPs, c.608A>G (p.E203G), c.646C>T (p.R216C), and c.852G>A (p.N226D). The sixth SNP 1212G>T in the 3'UTR was observed in 40% of the CHD cases. The SNPs c.646C>T and c.608A>G were shown to cause changes in their secondary structure. Ventricular septal defect was the more prominent CHD observed in our study population. The SNPs c.608A>G (p.E203G) and c.852G>A (p.N226D) were present only in CHD patients, indicating their association with CHDs.

Comparative study of dot enzyme immunoassay (Typhidot-M) and Widal test in the diagnosis of typhoid fever.

We compared the sensitivity and specificity of Typhidot-M and Widal test with blood culture (gold standard) for diagnosing typhoid fever in 105 children aged 1-15 years admitted with clinical suspicion of typhoid fever. Of the 105 cases, blood culture was positive for S.typhi in 41 (39%) children, Widal test was positive in 48 (45.7%) and Typhidot-M was positive in 78 (74.3%) cases. Sensitivity and specificity of Typhidot-M was 92.6% and 37.5% while sensitivity and specificity of Widal test was 34.1% and 42.8%, respectively. In children with fever of less than 7 days duration, Typhidot-M was positive in 97%, compared to 24.2% by Widal test. Typhidot-M is a simple and sensitive test for early diagnosis of typhoid fever in children.

Mysore childhood obesity study.

We conducted this study to document the prevalence of obesity, overweight and underweight in the school children aged 5 to 16 years from Mysore. 5 Principal Investigators and 13 Co-Investigators trained the teachers of 139 schools (Private--111, Govt--28) to record the vital statistics of the children studying in their schools. A total of 43,152 school children (23,527 boys and 19,625 girls) were surveyed. 36,354 children were from private schools and 6798 children were from Government (Govt) schools. Indian Academy of Pediatrics growth charts were used as reference. The prevalence of obesity, overweight and underweight were 3.4%, 8.5% and 17.2%, respectively. The prevalence of obesity was maximum in the age group of 5-7 years and in those from private schools.

Randomized double blinded controlled trial to evaluate the efficacy and safety of Bifilac in patients with acute viral diarrhea.

OBJECTIVE: To evaluate the efficacy and safety of Bifilac on reducing the episodes (frequency) and duration of diarrhea induced by rotaviral infection and to evaluate the efficacy of Bifilac to ameliorate the associated symptoms like dehydration and duration of rotaviral shedding in faeces. METHODS: 80 children aged between 3 months and 3 years were enrolled and divided into 2 groups, one group received standard therapy + placebo, the other group received standard therapy + probiotic (Bifilac) randomly. Children assessed for frequency and duration of diarrhea. Degree of dehydration, duration and volume of oral rehydration salt [ORS] therapy, duration and volume of Intra venous fluids and duration of rotaviral shedding. RESULTS: When compared to the placebo, Bifilac showed clinical as well as statistically significant reduction in Number of episodes (frequency) of diarrhea in a day, mean duration of diarrhea (in days) degree of dehydration, duration and volume of oral rehydration salt [ORS] therapy, duration and volume of intravenous fluid [IVF] therapy, duration of rotaviral shedding (P<0.01). CONCLUSION: The synbiotic, bifilac, appears to be a safe and very effective adjuvant in the management of acute rotaviral diarrhea.

Audit of aminoglycosides usage.

OBJECTIVE: This study was aimed to evaluate the usage patterns of aminoglycosides in pediatric patients for their appropriateness. METHODS: A retrospective review was conducted over a period of six months at J.S.S. Hospital, Mysore. Patients who received parenteral aminoglycosides and below the age of 12 years were included in this study. RESULTS: A total of 197 pediatric patients were evaluated for the appropriateness and was found to be 72%, 86%, 85%, 43% & 53% for indication, dose, duration, safety and cost effectiveness respectively. Majority of the patients were treated with gentamicin (53%). The most frequent indication was respiratory tract infections (50%). CONCLUSION: Effort was made to encourage judicious and quality use of aminoglycosides among the pediatricians of J.S.S. Hospital to ensure better patient care by implementation of the aminoglycosides guidelines.

Antibacterial acivity of the essential oil of lippie nodiflora.

The plant Lippia nodiflora (Family-Verbenaceae) has medicinal properties and particularly used as an antidandruff agent. The essential oil of the plant was tested for its antibacterial activity against both gram positive and Gram negative bacteria. It showed good activity and compared with standard neomycin sulphate. However, it was inactive in the case of shigella flexneri.