Dheeraj Shah

Promoting appropriate management of diarrhea: A systematic review of literature for advocacy and action: UNICEF-PHFI series on newborn and child health, India

BackgroundScaling up of evidence-based management and prevention of childhood diarrhea is a public health priority in India, and necessitates robust literature review, for advocacy and action.ObjectiveTo identify, synthesize and summarize current evidence to guide scaling up of management of diarrhea among under-five children in India, and identify existing knowledge gaps.MethodsA set of questions pertaining to the management (prevention, treatment, and control) of childhood diarrhea was identified through a consultative process. A modified systematic review process developed a priori was used to identify, synthesize and summarize, research evidence and operational information, pertaining to the problem in India. Areas with limited or no evidence were identified as knowledge gaps.ResultsChildhood diarrhea is a significant public health problem in India; the point (two-weeks) prevalence is 9–20%. Diarrhea accounts for 14% of the total deaths in under-five children in India. Infants aged 6–24 months are at the highest risk of diarrhea. There is a lack of robust nation-wide data on etiology; rotavirus and diarrheogenic E.coli are the most common organisms identified. The current National Guidelines are sufficient for case-management of childhood diarrhea. Exclusive breastfeeding, handwashing and point-of-use water treatment are effective strategies for prevention of all-cause diarrhea; rotavirus vaccines are efficacious to prevent rotavirus specific diarrhea. ORS and zinc are the mainstay of management during an episode of childhood diarrhea but have low coverage in India due to policy and programmatic barriers, whereas indiscriminate use of antibiotics and other drugs is common. Zinc therapy given during diarrhea can be upscaled through existing infrastructure is introducing the training component and information, education and communication activities.ConclusionThis systematic review summarizes current evidence on childhood diarrhea and provides evidence to inform child health programs in India.

What is submitted and what gets accepted in Indian Pediatrics: Analysis of submissions, review process, decision making, and criteria for rejection

ObjectivesTo identify the characteristics of the manuscripts submitted to the Indian Pediatrics; attributes of the peer-review process and decision-making; and factors associated with their acceptance or rejection.MethodsAll submissions to Indian Pediatrics during 2002 were analyzed by a retrospective review of records. Manuscripts were categorized by their place of origin (Indian vs. foreign), geographic region of India (north, south, east, west, central), submitting institution (teaching vs. non-teaching), subject (general pediatrics, systemic pediatrics, neonatology, genetic syndrome, allied sub-specialities, etc.), and type of article (research paper, case report, images, letter to editor, review, etc.). Manuscript details were recorded in a database that also included information on peer reviewer assignment, editorial and reviewer comments, and final disposition of the manuscript. Characteristics of accepted and rejected manuscripts were compared.ResultsIndian Pediatrics received 687 manuscripts for consideration in the year 2002; mostly from Indian authors (89%). Maximum contributions were received from North India (236, 39%) followed by 165 (27%) from South, 95 (16%) from West, 90 (15%) from Central and 26 (4%) from Eastern part of India. Of 687 papers, 457 (66%) articles qualified for peer review. Agreement between the reviewers was not significantly greater than that expected by chance; kappa for inter-rater agreement was 0.35, 0.17 and 0.21 between any two sets of reviewers for 431, 228 and 203 articles, respectively (P <0.005). Of 687 submitted manuscripts, 294(43%) were accepted, 347(50%) were rejected and no decision was possible on 46(7%) manuscripts. The top reasons for rejection were ‘absence of a message’, ‘lack of originality’, ‘inadequate methods’, ‘not relevant to journal’, ‘overinterpretation of results’, ‘unsatisfactory writing style’, ‘inaccurate/inconsistent/insufficient data’, and ‘inappropriate statistical analysis’, in that order. Median number of days (IQR) needed to reach the final decision was 81 (25–210) d; ranging from 8 (3–29.5) d for Images to180 (90–341) d for Research papers. No preference for acceptance was noted for foreign articles, geographic region of India, type of institution, or a particular topic, on both univariate and multivariate analysis.ConclusionIndian Pediatrics is receiving contributions from all over India. Majority of the manuscripts are peer-reviewed. Of every 10 articles submitted, almost 4 are accepted. Median time interval from submission to final decision is less than 3 months. The decision-making is not influenced by the place of origin of manuscript.

Role of zinc in severe pneumonia: a randomized double bind placebo controlled study

BackgroundPneumonia is a leading cause of morbidity and mortality in children.ObjectiveThe aim of study was to evaluate the efficacy of Zinc supplementation in treatment of severe pneumonia in hospitalized children.Design/MethodsA double blind randomized, placebo- controlled clinical trial conducted at a tertiary care centre of a teaching hospital. Children with diagnosis of severe pneumonia were randomly assigned to receive supplementation with either elemental zinc or placebo by mouth at the time of enrollment. From day 2, they received 10 mg of their assigned treatment by mouth twice a day for 7 days along with standard antimicrobial therapy.ResultsThe baseline characteristics like age, sex, weight, weight Z score, height, height Z score, weight for height Z score and hemoglobin were comparable in both study groups. The respiratory rate, chest indrawing, cyanosis, stridor, nasal flaring, wheeze and fever in both groups recorded at enrollment and parameters did not differ significantly between the two groups. The outcome measures like time taken for resolution of severe pneumonia, pneumonia, duration of hospital stay, nil per oral, intravenous fluid, oxygen use, treatment requiring 2nd line of drug and 3rd line drug were evaluated and found to be same.ConclusionThe present study did not show a statistically significant reduction in duration of severe pneumonia, or reduction in hospital stay for children given daily zinc supplementation along with standard antimicrobial therapy. Therefore, zinc supplementation given during the acute episode does not help in short term clinical recovery from severe pneumonia.

Maternal micronutrients and fetal outcome

Maternal micronutrient deficiency has been related to adverse fetal effects. It is believed that micronutrient supplementation during pregnancy may improve fetal and neonatal outcome. Despite biological plausibility, the evidence base for individual micronutrient benefit on neonatal morbidity, mortality, growth and development is patchy and often contradictory, except for the role of folic acid in prevention of neural tube defects. Single micronutrient supplementation interventions have not been shown to consistently affect size at birth or duration of gestation. Sound evidence is generally lacking that micronutrient supplementation can reduce infection-related adverse pregnancy outcomes. However, preliminary data suggests that antenatal zinc supplements may cause reduction in later diarrheal and infectious morbidity in infants. The evidence linking maternal micronutrient deficiency to children’s cognitive and motor functioning also lacks a clear consensus except for iodine in endemic areas. There is a pressing need for good quality randomized controlled trials evaluating food based and multiple micronutrient interventions in pregnancy and preconceptually. Future studies should also evaluate the effect on body composition and metabolism along with the functional consequences.

300,000 IU or 600,000 IU of Oral Vitamin D3 for Treatment of Nutritional Rickets: A Randomized Controlled Trial

ObjectiveTo evaluate the non-inferiority of a lower therapeutic dose (300,000 IU) in comparison to standard dose (600,000) IU of Vitamin D for increasing serum 25(OH) D levels and achieving radiological recovery in nutritional rickets.DesignRandomized, open-labeled, controlled trial.SettingTertiary care hospital.Participants76 children (median age 12 mo) with clinical and radiologically confirmed rickets.InterventionOral vitamin D3 as 300,000 IU (Group 1; n=38) or 600,000 IU (Group 2; n=38) in a single day.Outcome variablesPrimary: Serum 25(OH)D, 12 weeks after administration of vitamin D3; Secondary: Radiological healing and serum parathormone at 12 weeks; and clinical and biochemical adverse effects.ResultsSerum 25(OH)D levels [geometric mean (95% CI)] increased significantly from baseline to 12 weeks after therapy in both the groups [Group 1: 7.58 (5.50–10.44) to 16.06 (12.71–20.29) ng/mL, P<0.001]; Group 2: 6.57 (4.66–9.25) to 17.60 (13.71–22.60, P<0.001]. The adjusted ratio of geometric mean serum 25(OH)D levels at 12 weeks between the groups (taking baseline value as co-variate) was 0.91 (95% CI: 0.65–1.29). Radiological healing occurred in all children by 12 weeks. Both groups demonstrated significant (P<0.05) and comparable fall in the serum parathormone and alkaline phosphatase levels at 12 weeks. Relative change [ratio of geometric mean (95% CI)] in serum PTH and alkaline phosphatase, 12 weeks after therapy, were 0.98 (0.7–1.47) and 0.92 (0.72–1.19), respectively. The serum 25(OH)D levels were deficient (<20 ng/mL) in 63% (38/60) children after 12 weeks of intervention [Group 1: 20/32 (62.5%); Group 2: 18/28 (64.3%)]. No major clinical adverse effects were noticed in any of the children. Hypercalcemia was documented in 2 children at 4 weeks (1 in each Group) and 3 children at 12 weeks (1 in Group 1 and 2 in Group 2). None of the participants had hypercalciuria or hypervitaminosis D.ConclusionA dose of 300,000 IU of vitamin D3 is comparable to 600,000 IU, administered orally, over a single day, for treating rickets in under-five children although there is an unacceptably high risk of hypercalcemia in both groups. None of the regime is effective in normalization of vitamin D status in majority of patients, 3 months after administering the therapeutic dose.

Prevalence and outcome of hepatobiliary dysfunction in neonatal septicaemia.

Background: Cholestatic jaundice and liver enzyme abnormalities have been reported in neonatal septicaemia; the course, pattern, and outcome of such hepatobiliary dysfunction have not been described. Methods: One hundred fifty-three neonates with blood culture–positive sepsis were recruited from the neonatal intensive care unit of an urban hospital. Liver function tests were done on day 3 and day 10 in all of the cases. In babies with abnormal results (direct bilirubin >20% of total with a minimum level of 2 mg/dL or alanine aminotransferase [ALT] >50 U/L), tests were repeated weekly for 1 month and then fortnightly for 3 months or until normalization of values. Anthropometry was recorded at all of these visits. Results: Klebsiella pneumoniae was the commonest organism, isolated in 95.4% of subjects. Eighty-three (54.2%) subjects had hepatobiliary dysfunction in the form of either cholestatic jaundice (n = 65 [42.5%]) or derangement in ALT (n = 57 [37.3%]). The onset of cholestasis was seen by day 3 of sepsis in 80% (n = 52), with maximum value of direct bilirubin seen by the 10th day in 90% (n = 58). Only 15% (n = 10) continued to have cholestatic jaundice beyond 30 days of onset of sepsis, and it resolved by 60 days. Hepatic enzyme abnormalities followed a more protracted course: onset by day 10 in 95%, peak value by day 38 in 90%, and normalisation by 60 days in 82% of subjects. The prevalence of any hepatobiliary dysfunction was found less frequently in babies who died as compared with survivors (43.4% vs 56.7%; P < 0.01). The weight, length, and head circumference during follow-up visits were comparable between neonates with or without hepatobiliary dysfunction. Conclusions: Hepatobiliary dysfunction is common in Gram-negative neonatal septicaemia. The onset of abnormalities is early in most cases but ultimately resolve within 2 to 3 months after sepsis. The presence of conjugated hyperbilirubinemia in neonatal sepsis may carry a better prognosis in terms of survival and has no significant effect on growth during early infancy.

Mid-upper arm circumference v. weight-for-height Z-score for predicting mortality in hospitalized children under 5 years of age.

OBJECTIVE To compare the performance of mid-upper arm circumference (MUAC) against weight-for-height Z-score (WHZ) for predicting inpatient deaths in children under 5 years of age. DESIGN Diagnostic test accuracy study. SETTING Paediatric emergency department of a tertiary care hospital catering to semi-urban and rural population in Delhi, India. SUBJECTS Hospitalized children (n 1663) aged 6 months to 5 years, for whom discharge outcome was available, were consecutively recruited over 14 months. MUAC (cm), weight (kg) height (cm), clinical details and the outcome were recorded. MUAC (index test) was compared with WHZ based on the WHO growth standards (reference test) for predicting the outcome. RESULTS One hundred and twenty-four (7 %) children died during hospital stay. Both MUAC < 11·5 cm (adjusted OR (95 % CI): 3·7 (2·43, 5·60), P<0·001) and WHZ<-3 (2·0 (1·37, 2·99), P<0·001) served as independent predictors of inpatient mortality. However, MUAC was a significantly better predictor of mortality compared with WHZ in terms of area under the receiver-operating characteristic curve (MUAC=0·698, WHZ=0·541, P<0·001). MUAC<11·5 cm had the best trade-off of sensitivity and specificity for predicting inpatient mortality. A combination of WHZ<-3 and/or MUAC<11·5 cm did not significantly improve the predictive value over that of MUAC/WHZ, assessed individually. CONCLUSION MUAC<11·5 cm is a better predictor of mortality in hospitalized under-5 children, as compared with WHZ<-3. It should be measured in all emergency settings to identify the children at higher risk of death.

Vitamin D supplementation for treatment and prevention of pneumonia in under-five children: A randomized double-blind placebo controlled trial

ObjectiveTo evaluate the efficacy of single oral mega-dose of Vitamin D3 for treatment and prevention of pneumonia in underfive children.DesignRandomized, double blind, placebo-controlled trial.SettingTertiary-care hospital.Participants324 children (of 980 assessed) between 6 mo-5 y age (median (IQR): 12 (7,19.8) mo) with WHO-defined severe pneumonia. Of these, 126 (39%) were vitamin D deficient (serum 25(OH)D <12 ng/mL).Intervention100,000 IU of oral cholecalciferol (n= 162) or placebo (n= 162) in single dose, administered at enrolment.Outcome variablesPrimary: Time to resolution of severe pneumonia and proportion of children having recurrence of pneumonia in next 6 months; Secondary: Change in serum levels of 25(OH)D; immunoglobulins IgA, IgG, IgM, and cathelicidin 2 weeks following supplementation; and time taken for overall resolution of illness.ResultsMedian (95% CI) time for resolution of severe pneumonia was 30 (29, 31) h in the vitamin D group as compared to 31 (29,33) h in the placebo group [adjusted hazard ratio (95% CI): 1·39 (1·11, 1·76); P=0·005]. The risk of recurrence of pneumonia in next 6 months was comparable in the two groups [placebo: 36/158 (22·8%); vitamin D: 39/156 (25%); RR (95% CI): 1·13 (0·67,1·90); P=0·69]. Proportion of vitamin D deficient children declined from 38% to 4% in the supplementation group, and from 41% to 33% in the placebo group, two weeks after supplementation. There was no significant effect of vitamin D supplementation on serum levels of cathelicidin, IgA and IgG. The time taken for complete recovery from pneumonia, duration of hospitalization, and fever clearance time were comparable for the two groups. No adverse event was noted related to the intervention.ConclusionThere is no robust evidence of a definite biological benefit, either for therapy or prevention, to suggest a routine megadose supplement of vitamin D3 for under-five children with severe pneumonia.

Efficacy and safety of drotaverine hydrochloride in children with recurrent abdominal pain: A randomized placebo controlled trial

ObjectiveTo evaluate the efficacy and safety of Drotaverine hydrochroride in children with recurrent abdominal pain.DesignDouble blind, randomized placebo-controlled trial.SettingPediatric Gastroenterology clinic of a teaching hospital.Participants132 children (age 4-12 y) with recurrent abdominal pain (Apley Criteria) randomized to receivedrotaverine (n=66) or placebo (n=66) orally.InterventionChildren between 4-6 years of age received 10 mL syrup orally (20 mg drotaverine hydrochloride or placebo) thrice daily for 4 weeks while children >6 years of age received one tablet orally (40 mg drotaverine hydrochloride or placebo) thrice daily for 4 weeks.Outcome MeasuresPrimary: Number of episodes of pain during 4 weeks of use of drug/placebo and number of pain-free days. Secondary: Number of school days missed during the study period, parental satisfaction (on a Likert scale), and occurrence of solicited adverse effects.ResultsReduction in number of episodes of abdominal pain [mean (SD) number of episodes 10.3 (14) vs 21.6 (32.4); P=0.01] and lesser school absence [mean (SD) number of school days missed 0.25 (0.85) vs 0.71 (1.59); P=0.05] was noticed in children receiving drotaverine in comparison to those who received placebo. The number of pain-free days, were comparable in two groups [17.4 (8.2) vs 15.6 (8.7); P=0.23]. Significant improvement in parental satisfaction score was noticed on Likert scale by estimation of mood, activity, alertness, comfort and fluid intake. Frequency of adverse events during follow-up period was comparable between children receiving drotaverine or placebo (46.9% vs 46.7%; P=0.98)ConclusionDrotaverine hydrochloride is an effective and safe pharmaceutical agent in the management of recurrent abdominal pain in children.

Defining and measuring vulnerability in young people

Adolescents and youth, together addressed as “young people”, form the future building blocks of any society. They being most energetic and dynamic, tend to get involved in high-risk behaviors making themselves susceptible to criminal offences, accidents, physical injuries, emotional trauma, and medical problems — some of them extremely serious like transmission of human immunodeficiency virus (HIV). The concept of vulnerability is applicable to all the people who are more exposed to risks than their peers like the young people. In order to deal with social evils like criminal offences, domestic violence, sexual abuse, HIV, etc. we need to define vulnerability and understand the factors that influence it. This review also attempts to summarize the indicators of vulnerability and the data currently available to estimate its burden in India. Measuring the magnitude of vulnerability by means of certain indicators/variables might help us in devising tools to assess this poorly defined entity. This may also evolve a conceptual framework on which targeted remedial interventions can be devised and implemented.