Indian Academy of Pediatrics Revised Guidelines on Evaluation, Prevention and Management of Childhood Obesity.

JUSTIFICATION: The last guidelines for pediatric obesity were released in 2004 by Indian Academy of Pediatrics (IAP). Since then, there has been an alarming increase in prevalence and a significant shift in our understanding in the pathogenesis, risk factors, evaluation, and management of pediatric obesity and its complications. Thus, it was decided to revise and update the previous recommendations. OBJECTIVES: To review the existing literature on the burden of childhood obesity and its underlying etiology and risk factors. To recommend evaluation of childhood obesity and suggest optimum prevention and management strategies of childhood obesity. PROCESS: The following IAP chapters (Pediatric and Adolescent Endocrinology, Infant and Young Child feeding, Nutrition, Non-Communicable Disease and Adolescent Health Academy) were invited to nominate members to become part of the writing committee. The Committee held discussions on various aspects of childhood obesity through online meetings between February and August, 2023. Recommendations were then formulated, which were analyzed, revised and approved by all members of the Committee. RECOMMENDATIONS: Exogenous or primary obesity accounts for the majority of cases of childhood obesity. It is important to differentiate it from endogenous or secondary obesity as evaluation and management changes depending on the cause. In Indian, in children under 5 years of age, weight for length/height using WHO charts, and in children 5-18 years, BMI using IAP 2015 charts is used to diagnose overweight and obesity. Waist circumference should be routinely measured in all overweight and obese children and plotted on India specific charts, as it is a key measure of cardio-metabolic risk. Routine evaluation for endocrine causes is not recommended, except in short and obese children with additional diagnostic clues. All obese children more than ten years old should be evaluated for comorbidities like hypertension, dyslipidemia, hyperglycemia and non-alcoholic fatty liver disease/metabolic dysfunction associated steatotic liver disease (NAFLD/ MASLD). Prevention and management of childhood obesity mainly involves healthy diet practices, daily moderate to vigorous physical activity and reduced screen time. Pharmacotherapy may be offered as an addition to lifestyle interventions only in cases of class 3 obesity or if there are any life-threatening comorbidities. Finally, surgical management may be offered in children older than 12 years of age with class 2 obesity and associated comorbidities or class 3 obesity with/without comorbidities, only after failure of a proper trial of intense lifestyle modifications and pharmacotherapy for at least 6 months.

Immunogenicity and safety of quadrivalent and 9-valent human papillomavirus vaccines in Indian clinical trial participants.

The quadrivalent human papillomavirus (qHPV; HPV6/11/16/18) and 9-valent HPV (9vHPV; HPV6/11/16/18/31/33/45/52/58) vaccines have demonstrated efficacy, immunogenicity, and safety in international clinical trials. We report outcomes from three completed clinical trials in India: a single-arm study (V501-029 [NCT00380367]) in Indian girls (aged 9-15 years; N = 110) evaluating qHPV vaccine immunogenicity and safety; a subgroup analysis (n = 225) of Indian girls/boys (9-15 years) and women (16-26 years) from a global study (V503-002 [NCT00943722]) evaluating 9vHPV vaccine immunogenicity and safety; and a qHPV vaccine post-marketing safety surveillance study (V501-125) in Indian females (aged 9-45 years; N = 188) vaccinated during routine care. In V501-029 and V503-002, HPV vaccines were administered as 3 doses (Day 1, Month 2, Month 6). Serum HPV antibodies were evaluated by competitive Luminex immunoassays at Day 1 and Month 7 (both studies) and Months 12, 24, and 36 (V503-002 only). Adverse events (AEs) were collected by Vaccination Report Card. In V501-125, participants were actively surveilled for serious AEs (SAEs) within 30 days post-qHPV vaccination. In per-protocol analyses, qHPV and 9vHPV vaccines induced robust anti-HPV6/11/16/18 (V501-029) and HPV6/11/16/18/31/33/45/52/58 (V503-002) responses, respectively; ≥97% of participants seroconverted at Month 7 for each vaccine HPV type in both studies, and antibody responses persisted through 36 months in V503-002. The most common AEs were injection-site-associated. Most AEs were mild/moderate; no deaths, vaccine-related SAEs, or discontinuations due to AEs were reported. In V501-125, no SAE was reported. Overall, the qHPV and 9vHPV vaccines elicited robust antibody responses and were generally well tolerated in Indian participants.

Cost-Effective Recruitment need for 24x7 Paediatricians in the State General Hospitals in Relation to the Reduction of Infant Mortality.

INTRODUCTION: According to World Health Organisation (WHO), improvement of hospital based care can have an impact of upto 30% in reducing Infant Mortality Rate (IMR), whereas, strengthening universal outreach and family-community based care is known to have a greater impact. The study intends to assess how far gaps in the public health facilities contribute towards infant mortality, as 2/3rd of infant mortality is due to suboptimum care seeking and weak health system. AIM: To identify cost-effectiveness of employment of additional paediatric manpower to provide round the clock skilled service to reduce IMR in the present state health facilities at the district general hospitals. MATERIALS AND METHODS: A cross-sectional observational study was conducted in a tertiary teaching hospital and district hospitals of 2 districts (Hooghly and Howrah in West Bengal). Factors affecting infant mortality and shift wise analysis of proportion of infant deaths were analysed in both tertiary and district level hospitals. Information was gathered in a predesigned proforma for one year period by verifying hospital records and by personal interview with service personnel in the health establishment. SPSS software version 17 (Chicago, IL) was used. The p-value was calculated by Fischer exact t-test. RESULTS: Available hospital beds per 1000 population were 1.1. Percentage of paediatric beds available in comparison to total hospital bed was disproportionately lower (10%). Dearth of skilled medical care provider at odd hours in district hospitals resulted in significantly greater infant death (p < 0.0001), but was not seen in tertiary hospital. The investment for appointing four additional paediatricians for round the clock stay duty was found to be cost-effective. CONCLUSION: Provision of round the clock availability of skilled medical care may reduce hospital based infant mortality and it is cost-effective.

Evaluation of malnutrition as a predictor of adverse outcomes in febrile neutropenia associated with paediatric haematological malignancies.

AIM: Malnutrition has been reported in the literature to be adversely associated with outcomes in paediatric malignancies. Our objective in this paper was to evaluate malnutrition as a potential predictor for adverse outcomes in febrile neutropenia associated with haematological malignancies. METHODS: A prospective observational study was performed in a tertiary care teaching hospital of Kolkata, India. Forty-eight participants, suffering from haematological malignancy, were included. Participants were included if they experienced at least one episode of febrile neutropenia. For children aged <5 years, weight for height, height for age and weight for age were used as criteria for defining malnutrition, while body mass index for age was used in children ≥5 years. A total of 162 episodes of febrile neutropenia were studied. RESULTS: Thirty patients (30/48, 62.5%) included in the study had malnutrition. In bivariate analyses at patient level, there is a strong association between malnutrition and death (odds ratio (OR) 7.286, 95% confidence interval (CI) 0.838-63.345, one-tailed P = 0.044), and life-threatening complications show a moderate trend towards significance (OR 3.333, 95% CI 0.791-14.052, one-tailed P = 0.084). Survival functions were significantly different between malnourished and non-malnourished children (log rank test χ(2) = 4.609, degree of freedom = 1, P = 0.032). Wasting was associated with life-threatening complications in children aged <5 years (OR 14, 95% CI 1.135-172.642, one-tailed P = 0.036). Logistic regression analyses at episode level revealed that phase of treatment and respiratory system involvement were significant predictors of death, while malnutrition was not. CONCLUSION: Malnutrition may be a potential predictor of mortality in febrile neutropenia.

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.

OBJECTIVE: This 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 Indian children. DESIGN: Phase III, open, randomised, non-inferiority study. SETTING: 6 tertiary care hospitals located in India. PARTICIPANTS: Healthy participants aged 9-10 months not previously vaccinated against/exposed to measles, mumps, rubella and varicella or without a history of these diseases. INTERVENTIONS: Participants were randomised (2:2:1) to receive 2 doses of either MMRV (MMRV/MMRV group) or MMR followed by MMRV (MMR/MMRV group) or MMR followed by MMR+V (MMR/MMR+V, control group) at 9 and 15 months of age. Antibody titres against measles, mumps and rubella were measured using ELISA and against varicella using an immunofluorescence assay. MAIN OUTCOME MEASURES: To demonstrate non-inferiority of the 2 vaccination regimens versus the control in terms of seroconversion rates, defined as a group difference with a lower bound of the 95% CI >-10% for each antigen, 43 days postdose 2. Parents/guardians recorded solicited local and general symptoms for a 4-day and 43-day period after each vaccine dose, respectively. RESULTS: Seroconversion rates postdose 1 ranged from 87.5% to 93.2% for measles, 83.3% to 86.1% for mumps and 98.7% to 100% for rubella across the 3 vaccine groups. The seroconversion rates postdose 2 were 100% for measles, mumps and rubella and at least 95.8% for varicella across the 3 vaccine groups. Non-inferiority of MMRV/MMRV and MMR/MMRV to MMR/MMR+V was achieved for all antigens, 43 days postdose 2. The 3 vaccination regimens were generally well tolerated in terms of solicited local and general symptoms. CONCLUSIONS: The immune responses elicited by the MMRV/MMRV and MMR/MMRV vaccination regimens were non-inferior to those elicited by the MMR/MMR+V regimen for all antigens. The 3 vaccination schedules also exhibited an acceptable safety profile in Indian children. TRIAL REGISTRATION NUMBER: NCT00969436.

Randomized, open-label study of the impact of age on booster responses to the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine in children in India.

In this phase III, open-label, multicenter, and descriptive study in India, children primed with 3 doses (at ages 6, 10, and 14 weeks) of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) were randomized (1:1) to receive a booster dose at 9 to 12 (early booster) or 15 to 18 months old (late booster) in order to evaluate impact of age at booster. We also evaluated a 2-dose catch-up vaccination plus an experimental booster dose in unprimed children age 12 to 18 months. The early booster, late booster, and catch-up vaccinations were administered to 74, 95, and 87 children, respectively; 66, 71, and 81 children, respectively, were included in the immunogenicity according-to-protocol cohort. One month postbooster, for each PHiD-CV serotype, ≥95.2% (early booster) and ≥93.8% (late booster) of the children had antibody concentrations of ≥0.2 µg/ml; ≥96.7% and ≥93.0%, respectively, had opsonophagocytic activity (OPA) titers of ≥8. The postbooster antibody geometric mean concentrations (GMCs) were in similar ranges for early and late boosters; the OPA titers appeared to be lower for most PHiD-CV serotypes (except 6B and 19F) after the early booster. After dose 2 and postbooster, for each PHiD-CV serotype, ≥88.6% and ≥96.3%, respectively, of the catch-up immunogenicity according-to-protocol cohort had antibody concentrations of ≥0.2 µg/ml; ≥71.4% and ≥90.6%, respectively, had OPA titers of ≥8. At least 1 serious adverse event was reported by 2 children in the early booster (skin infection and gastroenteritis) and 1 child in the catch-up group (febrile convulsion and urinary tract infection); all were resolved, and none were considered by the investigators to be vaccine related. PHiD-CV induced robust immune responses regardless of age at booster. Booster vaccination following 2 catch-up doses induced robust immune responses indicative of effective priming and immunological memory. (These studies have been registered at www.clinicaltrials.gov under registration no. NCT01030822 and NCT00814710; a protocol summary is available at www.gsk-clinicalstudyregister.com [study ID 112909]).

A study on smoking and associated psychosocial factors among adolescent students in Kolkata, India.

Tobacco use among school children and adolescents is an increasing problem world-wide, particularly in the developing countries. A cross-sectional observational study was carried out in six co-educational high schools in Kolkata, West Bengal among 526 students of 15-19 years to determine the prevalence of smoking and to find out any difference among the smokers and non-smokers regarding factors related to family relations, peer group and personal characteristics. The overall rate of smoking was found to be 29.6%, mean age of initiation of smoking was earlier in males. Among smokers 75% students started smoking by 15 years. Smoking of father and peer group, family conflict and pornography addiction were found to have significant association with smoking of students. Early school health based interventions addressing these factors might help in effectively tackling this problem.

A phase III single arm, multicenter, open-label study to assess the immunogenicity and tolerability of a pentavalent DTwP-HepB-Hib vaccine in indian infants.

Compliance with recommended vaccinations for Indian infants is facilitated by using combination vaccines to minimize the number of required injections. The ready-to-use, preservative free, fully-liquid combination DTwP-HepB-Hib vaccine, Quinvaxem(®), offers convenience of administering five important vaccine antigens to infants in a single injection. This phase III, single-arm, multicenter study was designed to assess immunogenicity and safety of three doses of Quinvaxem(®) to Indian infants administered at 6, 10, and 14 weeks of age. Blood samples were taken prior to the first dose and at one month post last vaccination. Infants were observed clinically for any reaction approximately 30 min following each vaccination, and parents completed subject diaries for solicited local, systemic and any adverse events (AEs) following over a 5 d period. DTwP-HepB-Hib vaccine elicited strong immune responses that exceeded seroprotection/seroconversion thresholds against all vaccine antigens. At one month after third vaccination, percentages of infants achieving predefined protective antibody levels were 99% diphtheria; 100% tetanus; 98% Hepatitis B; 100% Hib short-term (≥ 0.15 µg/mL); 95% Hib long-term (≥ 1.0 µg/mL) protection; and relevant immune response was 99% for pertussis. The vaccine was well tolerated, with no vaccine-related serious AEs. Only one case of high fever (≥ 40 °C) was reported. The most frequently reported reactions were mild to moderate tenderness and erythema. Frequencies of all AEs declined with subsequent vaccinations. This study demonstrated that this convenient, fully-liquid DTwP-HepB-Hib vaccine is highly immunogenic and has a acceptable safety profile for use in Indian infants. ClinicalTrials.gov Identifier: NCT01470287. Clinical Trials Registry of India Number: CTRI/2011/11/002118.

Patient health questionnaire-9 as an effective tool for screening of depression among Indian adolescents.

PURPOSE: Detection of depression among adolescents in the primary care setting is of paramount importance, especially in resource-constrained countries such as India. This article discusses the diagnostic accuracy, reliability, and validity of the Patient Health Questionnaire-9 (PHQ-9) when pediatricians use it among Indian adolescents. METHODS: Pediatricians administered the PHQ-9 to 233 adolescent students aged 14-18 years, along with the Beck Depression Inventory. Our psychologist clinically diagnosed depression based on an International Classification of Diseases, 10th Revision, interview of participants. One month later, the PHQ-9 was readministered among students. We conducted appropriate analyses for validity and diagnostic accuracy. RESULTS: A total of 31 students (13.3%) had a form of depression on psychiatric interview. A PHQ-9 score of ≥5 was ideal for screening (sensitivity, 87.1%; specificity, 79.7%). In addition to good content validity, PHQ-9 had good 1-month test-retest reliability (r = .875) and internal consistency (Cronbach's α = .835). There was high convergent validity with the Beck Depression Inventory (r = .76; p = .001). The concordance rate between the PHQ-9 threshold score of ≥10 and the International Classification of Diseases, 10th Revision based diagnosis was good (Cohen's κ = .62). The area under the receiver operating characteristic curve for PHQ-9 was .939. CONCLUSIONS: The PHQ-9 is a psychometrically sound screening tool for use by pediatricians in a primary care setting in India. Because it is a short, simple, easy to administer questionnaire, the PHQ-9 has tremendous potential in helping to tackle the growing problem of depression among adolescents in developing countries.

Measuring new born foot length to identify small babies in need of extra care: a cross-sectional hospital based study.

OBJECTIVE: The neonatal mortality rate (NMR) continues to remain quite high, one important cause being preterm deliveries. The main obstacle in the pathway towards decreasing NMR is identification of babies in need of extra care. To analyze the utility of newborn foot length as a proxy measure for birth weight and gestational age. METHODS: A cross-sectional study done in a hospital of eastern India with 351 babies during 4 months. Right foot length of each recorded using a plastic, stiff ruler. FINDINGS: 48.1% babies were preterm, 51.8% low birth weight (LBW) and 33.3% very low birth weight (VLBW). Foot length less than 7.75 cm has 92.3% sensitivity and 86.3% specificity for identification of preterm neonates. For identification of LBW babies (<2500 gm) a foot length less than 7.85cm has 100% sensitivity and 95.3% specificity. Foot length less than 6.85 cm has 100% sensitivity and 94.9% specifity for identification of VLBW babies (<1500 gm). CONCLUSION: Foot length may be used in the identification of LBW and preterm babies who are in need of extra care.

A Comparative Study of the Management Decisions by IMNCI Algorithm and by Pediatricians of a Teaching Hospital for the Children Between 2 Months to 5 Years.

BACKGROUND: Integrated management of neonatal and childhood illness (IMNCI) is already operational in many states of India, but there are very few studies in Indian scenario comparing its validity and reliability with the pediatricians' decisions. OBJECTIVES: 1) To compare the IMNCI decision with the decision of pediatricians; 2) to assess the significance of multiple presenting symptoms in the IMNCI algorithm. MATERIALS AND METHODS: The study was conducted among the sick children between 2 months to 5 years presented in pediatric department from January to March 2009. The IMNCI decision was compared with pediatrician's decisions by percent agreement, Kappa and weighted Kappa with the aids of SPSS version 10. RESULTS: The overall diagnostic agreement between IMNCI algorithm and pediatrician's decisions was 36.64%, (Kappa 0.16 and weighted Kappa 0.29) with 51.15% over diagnosis and 12.21% under diagnosis. The importance given by IMNCI algorithm in cases of multiple presenting symptoms was also reflected as it was evident that 37.50% children presented with three symptoms were categorized as red, whereas it was 28.57% and 11.67% for those presented with two and one symptom, respectively, (P < 0.0001). Pediatricians also gave importance for presence of multiple symptoms by considering 50% as admissible in the group presented with three symptoms, 30.16% in the group presented with two symptoms, and 16.67% in the group presented with only one symptom. The association was also statistically significant (P = 0.018). CONCLUSION: Diagnostic discordance is seen mainly due to over diagnosis of all fever cases as malaria. Importance of presence of comorbidities was also reflected.

Bilateral giant-sized symmetrical pulmonary hydatid cysts in an 8-year-old girl.

An 8-year-old girl presented with a low-grade fever and cough for 4 weeks and minimal physical findings. Chest radiograph demonstrated two giant hydatid cysts occupying two-thirds of each lung and another two cysts in the liver were detected by ultrasonography. The cysts were resected from both lungs and the liver under albendazole cover. She made a complete recovery.

Immunogenicity, safety, and reactogenicity of the 10-valent pneumococcal non-typeable Hemophilus influenzae protein D conjugate vaccine (PHiD-CV) when co-administered with the DTPw-HBV/Hib vaccine in Indian infants: a single-blind, randomized, controlled study.

In India, pneumococcal diseases are major causes of child mortality, and effective vaccines against Streptococcus pneumoniae are needed. This single-blind, randomized study assessed the immunogenicity, reactogenicity, and safety of the 10-valent pneumococcal non-typeable Hemophilus influenzae (NTHi) protein D conjugate vaccine (PHiD-CV) co-administered with DTPw-HBV/Hib in Indian infants as 3-dose primary vaccination course. A total of 360 infants were randomized (2:1) to receive either PHiD-CV co-administered with DTPw-HBV/Hib (PHiD-CV group) or a Hib vaccine co-administered with DTPw-HBV (control group) at 6, 10, and 14 weeks of age. For each vaccine pneumococcal serotype, the percentage of infants in the PHiD-CV group with antibody concentrations ≥ 0.2 µg/mL one month after the third vaccine dose was at least 98.3%, except for serotypes 6B (77.7%) and 23F (89.5%), and opsonophagocytic activity titers ≥ 8 were measured in at least 95.7% of infants, except for serotypes 1 (90.5%) and 6B (84.5%). In addition, all the infants in the PHiD-CV group were seroprotected against diphtheria, tetanus, Hib, and hepatitis B or seropositive for antibodies against pertussis and NTHi protein D (except one infant). Incidences of solicited local and general symptoms were comparable between groups, except for fever (axillary temperature ≥ 37.5°C), which seemed to occur more frequently in the PHiD-CV group. In conclusion, PHiD-CV was shown to be immunogenic and well-tolerated when co-administered with DTPw-HBV/Hib in Indian infants.

Unique neurological manifestations of dengue virus in pediatric population: a case series.

Dengue infection is endemic in developing countries posing a major public health problem. Clinical manifestations form a broad spectrum and include uncomplicated dengue fever, dengue hemorrhagic fever and dengue shock syndrome. We report three confirmed cases of dengue infection in pediatric population with central nervous system involvement with certain unreported manifestations resulting in diagnostic dilemma. Increasing evidence of neurotropism by dengue virus emphasizes that clinician be aware of such association and consider dengue infection in cases of febrile encephalitis and myelitis in endemic areas. Early diagnosis and appropriate supportive cars can reverse this potentially fatal disease.

Food supplementation as an incentive to improve pre-antiretroviral therapy clinic adherence in HIV-positive children--experience from eastern India.

OBJECTIVE: To evaluate the importance of food supplementation as incentive in improving preantiretroviral therapy (pre-ART) adherence, and second its impact on health of HIV-infected children by a clinic-based observational study. METHODS: HIV-seropositive children aged between 2 and 12 years were followed-up sequentially for 2 years without and with food supplementation, respectively, with monitoring of disease parameters. The outcome morbidity parameters were compared and correlated. RESULT: Study showed significant improvement in clinic adherence (r = 0.165, p = 0.027) along with increased mean clinic visit (6.65 ± 1.43 vs. 8.01 ± 1.52, p = 0.000) and mean CD4 count (p = 0.028) with incentive. Provision of incentive correlated well (Pearson's r = 0.345) with number of visits which in turn had strong correlation with weight gain (r = 0.548), episodes of AIDS-defining illnesses (r = -0.412), hospitalization (r = -0.279). CONCLUSION: Food incentive could enhance pre-ART phase clinic adherence that decreases disease-related morbidities, setting the stage for improved treatment and care of seropositive children in future.

Granulocyte Colony-stimulating Factor for Preterms with Sepsis and Neutropenia: A Randomized Controlled Trial.

BACKGROUND: Bacterial sepsis is one of the major causes of mortality in newborn infants. Mortality increases when sepsis is associated with neutropenia. MATERIALS AND METHODS: We conducted a prospective, randomized, double-blind, placebo-controlled trial of recombinant human granulocyte colony-stimulating factor on preterm neonates (gestational age (GA) <34 weeks) with sepsis and absolute neutrophil count (ANC) of <1500 cells/mm(3). Mortality, duration of Neonatal Intensive Care Unit (NICU) stay, hematological parameters (ANC, platelet count, and total leukocyte count) were compared between the two groups. The GCSF group (n=39) received GCSF intravenously in a single daily dose of 10 µg/kg/day in a 5% dextrose solution over 20-40 min for three consecutive days, while the control group (n=39) received placebo of an equivalent volume of 5% dextrose. RESULTS: Baseline demographic profile among the two groups was comparable. Mortality rate in the GCSF group was significantly lower than in the control group (10% vs. 35%; P<0.05). By day 3 of treatment, ANC in the GCSF group was significantly higher (3521±327) compared to 2094±460 in the control group, with P value being <0.05. Duration of NICU stay also decreased significantly in the GCSF group. CONCLUSION: The administration of GCSF in preterms with septicemia and neutropenia resulted in lower mortality rates. Further studies are required to confirm our results and establish this adjunctive therapy in neonatal sepsis.

Adolescents speak: why do we smoke?

OBJECTIVES: To assess the role of different factors that are associated with initiation and continuation of adolescent smoking. MATERIALS AND METHODS: A total of 2535 students (1465 males and 1070 females) between the age groups of 14 and 19 years were selected from four schools and two colleges of the city by two-stage cluster sampling design for this cross-sectional study. RESULTS: The prevalence of cigarette smoking was 21.58%. Smoking was found to be considerably influenced with having seen best friend, father, sibling and favorite movie star smoke and also with receiving pocket money. CONCLUSION: Experimentation of substance use, motivated by family members, peer groups and the surrounding environment is common among adolescents and starts early in life. Therefore, it is necessary to come up with health promotion programs directed toward students which encourage attitude shaping among them toward self-confidence and healthy life style.