Healthy Indian Children Research Articles

COMPARATIVE STUDY OF PERIPHERAL BONE MINERAL DENSITY IN GOVERNMENT AND PRIVATE SCHOOL CHILDREN IN BIKANER DISTRICT RAJASTHAN

Summary -Peripheral bone density measurements are scarce and the factors, which predict bone mineral density at these sites, especially in children, are not clearly known. In this study, age, height, weight and BMI had a significant association on peripheral bone mineral density in healthy Indian school children.
 Introduction- Factors that lead to the attainment of peak bone mass at peripheral sites, during period of growth are not clearly known.
 Methods- Hundred children are randomly selected 7- to 17-year-old children from govt. and private schools were assessed clinically and a recording of their height and weight was undertaken. Bonemineral density measured by ultrasound bone densitometer. at the calcaneum (BMDca). 
 Results -bone mineral density is assessed in correlation of following parameters:-When age wise BMD was analysed between both study groups, government school children had lower BMD values in both age groups (7-11 years, 12-17 years) and the difference between BMD in both age groups was statistically highly significant (p<0.01).Considering sex wise distribution of Bone mineral density it was clearly shown that BMD among private school children had higher values among both males and females, and the difference is statistically highly significant (p<0.01) among females. When Bone mineral density levels were compared according to BMI levels, the difference was observed to be not significantly associated with BMI levels (p>0.05) though government school children showed lower BMD levels as compared to private school children.
 Conclusion -age, nutrition, height and weight are significantly associated with BMD at peripheral sites.
 Keywords: Bone mineral density, Distal forearm, ultrasound bone densitometer, Socioeconomic status.

Daily Iron Requirements in Healthy Indian Children and Adolescents

This study aimed to define the estimated average requirement and the recommended dietary allowance of iron for Indian children and adolescents. The Estimated average requirement was derived for children aged 1-17y, from the mean bioavailability-adjusted daily physiological iron requirement, which in turn was estimated using a factorial method. This consisted of mean daily iron losses from the body and additional iron required for tissue growth and storage, while also defining the variance of each factor to derive the Recommended dietary allowance. Results: The estimated average requirement of iron for children ranged from 5.6 to 11.0 mg/d in children aged 1-9y. For adolescents aged 10-17y, these ranged from 10.8 to 18.4 mg/d and 15.4 to 18.5 mg/d for adolescent boys and girls, respectively. New estimates of estimated average requirement for iron in Indian children are presented, and same may be used to inform iron supplementation and food fortification policies.

Pharmacokinetic Modeling of Propofol in Indian Children

Objective: To analyse the PK (pharmacokinetics) of propofol after single bolus dose in children undergoing elective general surgery and to establish a PK model of propofol after single bolus dose in children undergoing elective general surgery and to establish a PK model of propofol. Materials and Methods: Twelve healthy Indian children aged 5–12 years who underwent elective general surgery under general anesthesia received propofol at an intravenous bolus dose of 2.5 mg/kg. The plasma propofol concentration over the next 12 h was estimated using high-performance liquid chromatography. A total of 144 samples were analyzed, and PK parameters were evaluated using nonlinear mixed-effects modeling. Results were validated using bootstrap analysis, and visual predictive check was done to evaluate the final model. Results: Propofol PK in Indian children was characterized by a three-compartment model similar to adults. The model derived estimates of PK parameters are as follows: volume of the central compartment (V1) = 598.73 ml/kg, volume of the second compartment (V2) = 821.12 ml/kg, volume of the third compartment (V3) = 1097 ml/kg, systemic clearance (CL1) = 22.1 ml/kg/min, and intercompartmental clearances CL2 and CL3 which were 42.5 ml/kg/min and 10.4 ml/kg/min, respectively. Conclusion: The final PK model imparted a robust characterization of propofol PK. Inclusion of body weight as a covariate to the model exhibited a significant impact on propofol PK. The execution of this patient derived PK model should support future population PK studies that include diverse population with sparse sampling to support the dosing of propofol in Indian children undergoing surgery under total intravenous anesthesia.

Reference values of ECG parameters derived from 906 echocardiographically confirmed healthy Indian children: A population-based study from Gujarat

IntroductionThere are few published studies on reference ranges of ECG parameters in children; some ethnic differences have been described. MethodsWe studied digital 12‑lead ECGs (1000 samples/s) from 906 healthy rural Indian children (467 boys: 439 girls) aged 5–15 years. PR, QRS, and QT were measured using superimposed median beat. Age-wise normal limits (median, 2nd and 98th percentile) were defined. ResultsHeart rate decreased while PR interval and QRS duration increased with age. QTcB interval remained unchanged from 5 to 12 years and decreased thereafter due to QTcB shortening in boys but not in girls. “Juvenile T wave pattern” was seen in 95% of children aged 5–8 years in lead V1 and 55–60% in V2, V3; it decreased with age. RV dominance (R/S > 1) in lead V1 was seen in 13% at 5 years, 1% at 10 years and none at 14 years. ConclusionReference ranges in Indian children are similar to those in other ethnic groups.

Bowel Habits of Healthy Indian Children Less Than Two Years of Age

Objectives: To define the normal frequency and consistency of stools of healthy Indian children between 0-24 months of age. Material and Methods: Parents of children aged up to 24 months were asked on a three-day recall basis about their child’s usual bowel habits and dietary history. Bowel habit was recorded in terms of number of stools the child passes per day, stool consistency, the age at which night bowel movements stopped, and age of regular bowel movements. Feeding type was recorded as exclusive breast feed, mixed milk feeds or on solid feeds. The bowel habits were correlated with the age of the child and type of feeding. Results: Children in first six months of life had stools which were predominantly “pasty” and “runny like cream” with high and variable frequency. Beyond six months of age they had “solid” and “pasty” stools with a frequency of one to two per day. On analyzing the combined effect of type of milk feed and age on bowel frequency and consistency children beyond one month of age either on exclusive breast feed or on mixed milk feed had similar frequency and consistency of stools. By one year of age more than 90% of children had attained regular stool pattern and no night time bowel movements. Conclusions: First of its kind study from India which describes the stool pattern of normal healthy children less than two years of age.

Reference centile curves for wrist circumference for Indian children aged 3-18 years.

Childhood obesity and its consequences have reached alarming proportions worldwide and in India. Wrist circumference is emerging as an easily measurable reproducible parameter for screening children at risk of obesity-related morbidities such as hypertension and insulin resistance. The objectives of this study were: (1) to compute age and gender-specific wrist circumference percentiles for 3-18-year-old apparently healthy Indian children and adolescents; (2) to assess the relationship of wrist circumference with measures of obesity and adiposity such as body mass index (BMI), fat percentage and blood pressure (BP) and (3) to suggest age and gender-specific cut-offs for wrist circumference percentile for the risk of hypertension in Indian children and adolescents. This was a cross-sectional study on samples of 10,199 3-18-year-old children (5703 boys) from randomly selected schools from five major cities in India. Height, weight, waist and wrist circumference and BP were recorded. Body composition was measured using bioelectrical impedance analysis (BIA). Wrist circumference percentiles were computed using the LMS method. The average wrist circumference of boys and girls was 10.4 cm and 10.0 cm at 3 years and increased to 15.1 cm and 13.9 cm, respectively, at 18 years. Compared to their Caucasian counterparts, Indian children's wrists were smaller. Receiver operating characteristic (ROC) curve analysis derived the 70th percentile of wrist circumference as the cut-off for identifying the risk of hypertension. Contemporary cross-sectional reference percentile curves for wrist circumference for 3-18-year-old Indian children are presented. The 70th percentile of the current study is proposed as the cut-off to screen children for cardiometabolic risk factors such as hypertension.

Normative Data for IVC Diameter and its Correlation with the Somatic Parameters in Healthy Indian Children.

To determine the normative data for inferior vena cava (IVC) diameter in children and its correlation with various somatic parameters like height, weight and body surface area in Indian children. Readily available baseline data of IVC diameter in normal children shall be of great help in rapid assessment of variations in sick children. Total 475 healthy children aged one month to 12 y visiting out patient clinics (OPD's) were enrolled in this study. Weight, height and body surface area were calculated at the time of examination. The maximum and minimum diameters of IVC were measured during the expiratory and inspiratory phase of the respiratory cycle respectively using M mode ultrasonography. Collapsibility Index was also calculated for each subject by measuring difference between the maximum (expiratory) and minimum (inspiratory) IVC diameters divided by the maximum diameter. The mean age of study subjects was 4.72±3.72 y. Out of 475 subjects, 285 (60%) were boys and 190 (40%) were girls. Mean weight for age (%) of subjects was 89.18±13.26%. Correlation was studied between physical parameters and IVC diameter which revealed a positive correlation of age, height and weight with both maximum and minimum IVC diameter. Regression analysis was also performed to derive the equations for maximum and minimum diameters of children from 1 y to 12 y. This study provides reference values of IVC diameters for Indian children of different age groups.

Validation of Bioelectric Impedance Analysis against Dual-energy X-Ray Absorptiometry for Assessment of Body Composition in Indian Children Aged 5 to 18 Years.

To validate body composition measurements by Bioelectric Impedance Analysis (BIA) against Dual-Energy X-ray Absorptiometry (DXA) as the reference method in healthy children and adolescents. Cross-sectional. Schools in and around Pune city, India. A random sample of 210 (114 boys, 96 girls) apparently healthy Indian children and adolescents (5-18 y). Weight, height, Tanner stage (TS) were recorded. Body composition measures: fat-free mass (FFM), fat mass (FM), lean mass (LM), bone mineral content (BMC) and body fat percentage (%BF) were assessed by BIA and DXA on a single day. Agreement between the methods was estimated by Pearson's correlation, and Bland and Altman analysis. %BF, FM, FFM, LM, BMC. BIA underestimated %BF by 6.7 (3.7)% as compared to DXA. Mean FFM, BMC and LM by BIA were significantly higher than by DXA (P<0.001). These differences remained similar after adjusting for age, BMI and TS. Mean differences between FFM (-2.32 (1.39) kg), BMC (-0.18 (0.15) kg), and LM (-2.15 (1.34) kg) by DXA and BIA were significant (P<0.01). Correlations between BIA and DXA were 0.92 for %BF, 0.96 for LM and 0.98 for FFM and BMC. Both the methods were similar in identifying normal and overfat children as per their respective cut-offs. BIA and DXA techniques are not interchangeable for assessment of body composition. However, BIA may be used in the field/clinical setting preferably with ethnicity specific references.

Evaluation of maximal mouth opening for healthy Indian children: Percentiles and impact of age, gender, and height.

Background and Aim:Maximal mouth opening (MMO) is used as a marker of masticatory pathology. However, MMO among children varies considerably with their age, height, sex, and race. While accurate percentile of normal mouth opening and relationship with anthropometric measurement are not precisely defined for the Indian population, we designed prospective, observational study to define the percentiles for normal MMO in our children.Methods:A total of 985 children, 560 males and 425 females, in the age range of 5–18 years attending the pediatric clinic in a tertiary care center in Western India were studied. In addition to the basic demographic data, MMO was measured in these children. The children were asked to open their mouth maximally until no further opening was possible. The distance from the incisal edge of the upper incisor teeth to the incisal edge of the lower incisor teeth was measured using a calibrated fiber ruler. Statistical analysis was performed to assess the impact of other anthropometric measures such as age, gender, and height on MMO.Observations:The mean MMO for males was 44.24 (±5.84) mm and for females was 43.5 (±5.19) mm. Age- and height-related percentiles were created for girls and boys separately, showing the 5th, 10th, 25th, 50th, 75th, 90th, and 95th percentiles from 5 through 18 years of age with 86–185 cm height.Conclusion:The MMO percentile range for different age and height groups is established for the normal children. The mouth opening seems to increase with the age and especially with the height as per the skeletal growth. Height affects mouth opening more than the age.

Immunogenicity and safety of early vaccination with two doses of a combined measles-mumps-rubella-varicella vaccine in healthy Indian children from 9 months of age: a phase III, randomised, non-inferiority trial

ObjectiveThis study (NCT00969436) compared the immunogenicity and safety of measles-mumps-rubella (MMR) followed by MMR+varicella (V) vaccines to (1) 2 doses of combined MMRV and (2) MMR followed by MMRV, in...

Clinical test of sensory interaction in balance (CTSIB): Concurrent validity study in healthy Indian children

The Clinical Test of Sensory Interaction for Balance (CTSIB) is an inexpensive, easily administered test, which provides information about the ability to stand upright under several sensory conditions. This study was intended to find the Concurrent Validity in Healthy Indian Children aged 7–12 yr using a force plate. This study included 48 normal children between the ages of 7–12 yr. The children were screened for inclusion and exclusion criteria. The CTSIB score on therapist’s observation was compared with force plate measures to find concurrent validity. The Concurrent Validity for the CTSIB was calculated using Pearson’s Correlation Coefficient. The “r” value for concurrent validity was 0.681 and 0.799 with force plate measures, showing good correlation. One-way analysis of variance was done to see the difference between age group (7–8,9–10,11–12) and CTSIB using post hoc Tukey analysis. This revealed a significant difference between groups aged 7–8 and 11–12, with P = 0.006, and between 9–10 and 11–12 with P = 0.03. From this study, we conclude that the CTSIB is a valid test for balance evaluation in Indian children.

Relationship of IGF1 and bone parameters in 7--16 year old apparently healthy Indian children

Relationship of IGF1 and bone parameters in 7--16 year old apparently healthy Indian children

Long term follow-up study to evaluate immunogenicity and safety of a single dose of live attenuated hepatitis a vaccine in children

Worldwide, viral hepatitis continues to be a cause of considerable morbidity and mortality. Mass immunization with a single dose of live attenuated HAV has been shown to significantly reduce disease burden in the community. This was a phase IV, 5-year follow up study carried out at 4 centers (Kolkata, Delhi, Mumbai and Chennai) across India. The subjects with antibody titer <20 mIU/mL at baseline were evaluated for long term immunogenicity. Of the 503 subjects enrolled, 349 subjects were baseline seronegative with an anti-HAV antibody titer <20 mIU/mL. Overall, 343 subjects could be followed up at some point of time during this 5 y post vaccination period. In the last year (60 months) of follow-up, 108 subjects (97.3%) of 111 subjects (who came for follow-up at the end of 5 y) had a protective antibody titer (anti-HAV antibody titer >20 mIU/mL). The seroconversion rates considering seroprotection levels of anti-HAV antibody titer >20 mIU/mL, following vaccination starting from 6 weeks, 6 months, 12 months, 24 months, 36 months, 48 months and 60 months were 95.1%, 97.9%, 98.3%, 96.2%, 97.8%, 92.6% and 97.3%, respectively. The geometric mean concentration (GMC) over the years increased from 64.9 mIU/mL at 6 weeks to 38.1 mIU/mL and 135.2 mIU/mL at 6 months and 12 months, respectively and was maintained at 127.1 mIU/mL at 60 months. In conclusion, the result of this 5-year follow up study showed that the single dose of live attenuated vaccine is well tolerated and provides long-term immunogenicity in healthy Indian children.

Safety and immunogenicity of single dose live attenuated varicella vaccine (VR 795 Oka strain) in healthy Indian children: A randomized controlled study

Varicella, an acute viral systemic infection that may cause lifelong latent infection with the potential for causing clinical reactivation, may be prevented by immunization. The present study was an open label, randomized, controlled, phase III, multicentre trial, conducted to evaluate and compare the safety, tolerability and immunogenicity of a freeze dried live attenuated Oka strain Varicella Vaccine (VR 795 Oka strain) with Varilrix (Oka-RIT strain) in children. A total of 268 healthy Indian children aged 12 months to 12 y with baseline VZV IgG antibody (<100 mIU/ mL) were enrolled, and 256 children completed the study. The extent of rise of VZV IgG antibody titer assessed as 3-fold and 4-fold rise from baseline was found to be significantly higher (89.1% and 85.2%) in the test group as compared to control group (73.4% and 61.7%). The post-vaccination GMT of the test group was significantly higher (112.5 mIU/mL) as compared with the control group (67.8 mIU/mL) (P < 0.001). The seroconversion rate considering the 5 gp ELISA units/ml equivalent to 10mIU/ml were similar in the control (96.5%) and the test (98.3%) groups. The adverse events were not different in the control and test groups (P > 0.05). The test live attenuated vaccine was found to be highly immunogenic, safe and comparable to Varilrix used in control arm.

Choroidal thickness profile in healthy Indian children.

Purpose:The purpose was to study choroidal thickness and its profile based on location in healthy Indian children using enhanced depth spectral-domain-optical coherence tomography (SD-OCT).Methods:In this cross-sectional observational study 255 eyes of 136 children with no retinal or choroidal disease were consecutively scanned using enhanced depth SD-OCT. Eyes with any ocular disease or axial length (AXL) >25 mm or < 20 mm were excluded. A single observer measured choroidal thickness from the posterior edge of the retinal pigment epithelium to the choroid/sclera junction at 500-microns intervals up to 2500 microns temporal and nasal to the fovea. Generalized estimating equations were used to evaluate the correlation between choroidal thickness at various locations and age, AXL, gender and spherical equivalent (SEq).Results:Mean age of the subjects was 11.9 ± 3.4 years (range: 5–18 years). There were 62 Females and 74 males. The mean AXL was 23.55 ± 0.74 mm. Mean subfoveal choroidal thickness was 312.1 ± 45.40 μm. Choroid was found to be thickest subfoveally, then temporally. Age, AXL and SEq showed a significant correlation with choroidal thickness, whereas gender did not affect choroidal thickness.Conclusion:Our study provides a valid normative database of choroidal thickness in healthy Indian children. This database could be useful for further studies evaluating choroidal changes in various chorioretinal disorders. Age and AXL are critical factors, which negatively correlated with choroidal thickness.

Relationship of insulin-like growth factor 1 and bone parameters in 7-15 years old apparently, healthy Indian children.

Objective:Growth hormone through insulin-like growth factor 1 (IGF-1) plays an important role in both bone growth and mineralization. This cross-sectional study was carried out to evaluate the relationship between serum IGF-1 concentrations and dual energy X-ray (DXA) measured whole body less head bone area (BA), lean body mass (LBM), and bone mineral content (BMC).Methods:One hundred and nineteen children (boys = 70, age = 7.3–15.6 years) were studied for their anthropometric parameters by standard methods and bone and body composition by DXA. Their fasting serum IGF-1 concentrations were assessed by enzyme-linked immunosorbent assay and Z-scores were calculated using available reference data. Bone and body composition parameter Z-scores were calculated using ethnic reference data.Results:Mean age of the boys and girls was similar (11.5 ± 1.8 years). The mean serum IGF-1concentrations and IGF-1 Z-scores were similar (P > 0.1) between boys and girls and were of the order of (302.3 ± 140.0 and − 1.4 ± 1.1, respectively). The LBM for age and BA for age Z-score was greater in children with IGF-1 Z-score > median than children with IGF-1 Z-score < median. The mean BMC for age Z-scores were 0.4 ± 0.9 and − 0.2 ± 0.8 in children with above and below the median of IGF-1 Z-score (P > 0.1).Conclusion:Serum IGF-1 levels were more strongly associated with BA and LBM, suggesting that its effect on bone is greater with respect to periosteal bone acquisition and through its effect on muscle mass.

Assessment of normal portal vein diameter in children

The internal diameter of the portal vein varies with age and anthropometric parameters. The caliber of the normal portal vein in adults has been extensively studied but little is known about portal vein dimensions in the growing child. This study was conducted to establish standards of portal vein diameter by ultrasonography in healthy Indian children based on age, gender and anthropometric parameters. Total 306 healthy children between the age of < 1 month and 12 years, visiting our outpatient departmentor accompanying their siblings were enrolled in the study. The children were distributed into ten age-groups. Each group was further divided in two sub-groups based on gender. Anthropometric parameters including weight, height and chest circumference were measured.Portal vein diameter was assessed by ultrasonography. The portal vein diameter increases with age, height, weight and chestcircumference. But the values are similar in boys and girls. Multiple logistic regression (adjusted R- square: 0.922) revealed age (p = 0.002), height/length (p < 0.0001), weight (p = 0.011), and chest circumference (p < 0.0001), as independent determinants of portal vein diameter. However, height/length emerged as the most consistent determinant (coefficient of regression: 1.536; p < 0.001; 95% confidence interval: 0.066-0.092). Our results provide a normal range of portal vein diameter according to age, gender and anthropometric parameters. We conclude that portal vein diameter strongly correlates with age and anthropometric variables like height, weight and chestcircumference,with height being the strongest determinant.

Immunogenicity and safety of a pediatric dose of a virosomal hepatitis A vaccine in healthy children in India

As India is transitioning from high to intermediate hepatitis A endemicity, the need for hepatitis A vaccination programs increases. This study investigated the immunogenicity and safety of a virosomal hepatitis A vaccine (HAVpur Junior) compared with an aluminum-adsorbed hepatitis A vaccine (Havrix 720 Junior) in Indian children. Healthy children aged 18–47 months, stratified by age, were randomized to either HAVpur Junior or Havrix 720 Junior. The first dose of vaccine was administered on Day 1 and the second (booster) dose 6 months later. Antibodies against hepatitis A virus (HAV) were measured using a microparticle enzyme immunoassay. The primary objective assessed non-inferiority of HAVpur Junior to Havrix 720 Junior in terms of seroprotection rates (≥ 10 mIU/mL anti-HAV antibodies) at 1 month after the first vaccination. Non-inferiority was demonstrated if the lower limit of the 90% confidence interval of the group difference was greater than –10%. Local and systemic adverse events were recorded. The seroprotection rate at 1 month was 95.9% in the HAVpur Junior group and 96.6% in the Havrix 720 Junior group. As the lower limit of the 90% confidence interval of the group difference was greater than –10% (–4.7), non-inferiority of HAVpur Junior to Havrix 720 Junior was established. The overall incidence of adverse events (solicited and unsolicited) after each vaccination was similar in both groups. In conclusion, the aluminum-free virosomal vaccine HAVpur Junior induced a similar immune response to Havrix 720 Junior in healthy Indian children aged 18 to 47 months. Both vaccines were well tolerated. The study shows that the low-dose virosomal HAV vaccine is consistently efficacious and well tolerated in children of all age groups and is suitable for inclusion into Indian childhood vaccination schedules.

Immunogenicity and safety of live attenuated hepatitis A vaccine (Biovac-A&amp;trade;) in healthy Indian children

Immunogenicity and safety of live attenuated hepatitis A vaccine (Biovac-A&amp;trade;) in healthy Indian children

Size at birth, morning cortisol and cardiometabolic risk markers in healthy Indian children

Prenatal programming of the hypothalamic-pituitary-adrenal (HPA) axis may link reduced foetal growth with higher adult chronic disease risk. South Asians have a high prevalence of low birth weight and a thin-fat phenotype, which is associated with subsequent type 2 diabetes and the metabolic syndrome. Altered HPA activity could be one of the pathological processes underlying this link. Plasma morning cortisol and corticosteroid-binding globulin (CBG) concentrations were determined in 528 children aged 9·5 years from a prospective birth cohort in India. They had detailed anthropometry at birth, and current measurements of anthropometry, plasma glucose, insulin and lipid concentrations and blood pressure. Insulin resistance (Homeostasis Model Assessment) and insulin secretion (the 30-min insulin increment) were also assessed. None of the birth measurements were associated with cortisol concentrations, but both birth weight (P = 0·03) and length (P = 0·004) were inversely associated with CBG concentrations. Cortisol concentrations were inversely associated with current body mass index (P = 0·02), and positively associated with glucose (fasting: P < 0·001; 30-min: P = 0·002) concentrations, and systolic blood pressure (P = 0·005), but not insulin resistance or the insulin increment. Higher morning cortisol is associated with higher cardiometabolic risk markers in Indian children. Although cortisol concentrations did not appear to be related to birth size, small size at birth was associated with higher CBG levels, and may be one of the processes by which foetal undernutrition affects adult health. The findings suggest a need for dynamic testing of HPA axis activity (such as measuring stress responses).