Mortality and Other Outcomes in Relation to First Hour Fluid Resuscitation Rate: A Systematic Review.

Objective: To determine the effect of different regimen of first hour fluid administration rates on mortality and severe consequences of impaired circulation in 2 to 60 months old children with impaired circulation. Design: Systematic review of randomized controlled trials. Data sources: Various databases including PubMed, Cochrane Library and EMBASE were searched. Results: We found only two relevant trials; one was excluded as there was no comparator arm. Only one study (The FEAST Trial) compared boluses with maintenance fluid alone in children with severe febrile illness and one or more signs of impaired perfusion. The 48-hour mortality was more in the bolus group (RR 1.45, 95% CI 1.13,1.86). The quality of evidence is rated as ‘moderate’. For the children who met the WHO criteria for shock (severely impaired circulation) (n=65 children), those receiving boluses had higher mortality (RR 2.40, 95% CI 0.84, 6.88); the quality of evidence was rated as ‘very low’. Conclusions: A single large randomized controlled trial conducted in low-resource settings indicates that administration of fluid bolus is associated with higher mortality in comparison to the maintenance fluids alone in children with severe febrile illness and one or more signs of impaired perfusion. The findings are not generalizable to contexts with different severity of and different causes of shock and in centers with better facilities. There is urgent need for research in different settings to determine the optimal rate of fluid resuscitation in the first hour in children presenting with impaired circulation, particularly with severely impaired circulation.

Variability of Thinness and its Relation to Cardio-metabolic Risk Factors using Four Body Mass Index References in School-children from Delhi, India.

Objectives: To compare: (i) prevalences of thinness in schoolchildren by four body mass index references in common use viz., Centre for Disease Control (CDC); Cole; Indian Academy of Pediatrics (IAP); World Health Organization (WHO); and (ii) relationship of thinness with absence of cardio-metabolic risk factors in these BMI references. Design: Cross-sectional. Setting: Schools in Delhi. Participants: Anthropometry and blood pressure were measured in 16,245 school children aged 5 to 18 years. Fasting lipids and blood sugar were estimated in 2796 subjects. Outcome measures: Age and sex-specific prevalences of thinness and predictive ability of reference cut-off for detecting any cardio-metabolic risk factor were compared. Results: Prevalence of thinness varied with the reference employed; more so for boys. Overall prevalence of thinness was least with IAP reference and highest with CDC cut-offs (6.6% to 16.9% in boys, 6.5% to 10.3% in girls). Children identified as thin by any reference had comparable, significantly lower risks (OR 0.59 to 0.73) of associated cardio-metabolic aberrations. In subjects with any cardio-metabolic or blood pressure aberration, the prevalence of thinness was highest with CDC and least with IAP definition. Conclusion: Prevalence of thinness varies considerably with the reference employed. Thin children, identified by any reference, have a lower risk of associated cardio-metabolic aberrations; however, thinness is a poor diagnostic test for this purpose. In populations undergoing nutrition transition, there is a need to link cardio-metabolic risk factors with recommended anthropometric criteria to define undernutrition.

Massive dose vitamin A programme in India - Need for a targeted approach.

The National Prophylaxis Programme against Nutritional Blindness due to vitamin A deficiency (NPPNB due to VAD) was started in 1970 with the specific aim of preventing nutritional blindness due to keratomalacia . The Programme was launched as an urgent remedial measure to combat the unacceptably high magnitude of xerophthalmic blindness in the country seen in the 1950s and 1960s. Clinical VAD has declined drastically during the last 40 years. Also, indicators of child health have shown substantial gains in different States in the country. The prevalence of severe undernutrition has come down significantly. Immunization coverage for measles and other vaccine preventable diseases has improved from 5-7 per cent in early seventies to currently 60-90 per cent, in different States. Similarly, there has been a significant improvement in the overall dietary intake of young children. There has been virtual disappearance of keratomalacia, and a sharp decline in the prevalence of Bitot spots. Prophylactic mega dose administration of vitamin A is primarily advocated because of the claim of 23 per cent reduction in childhood mortality. However, benefits on this scale have been found only in areas with rudimentary health care facilities where clinical deficiency is common, and there is substantial heterogeneity, especially with inclusion of all trials. There is an urgent need for adopting a targeted rather than universal prophylactic mega dose vitamin A supplementation in preschool children. This approach is justified on the basis of currently available evidence documenting a substantial decline in VAD prevalence, substantial heterogeneity and uncertainty about mortality effects in present era with improved health care, and resource constraints with competing priorities.

Consensus Statement of the Indian Academy of Pediatrics on Integrated Management of Severe Acute Malnutrition.

Justification: Severe acute malnutrition (SAM) is a major public health issue. It afflicts an estimated 8.1 million under-five children in India causing nearly 0.6 million deaths. The improved understanding of pathophysiology of SAM as well as new internationally accepted growth charts and newer modalities of integrated intervention have necessitated a relook at IAP recommendations. Process: A National Consultative Meeting on Integrated Management of Severe Acute Malnutrition was held in Mumbai on 16th and 17th October, 2010. It was attended by the invited experts in the field. Extensive discussions were held as per the program. The participants were then divided into six groups for detailed discussions. The groups deliberated on various issues pertaining to the task assigned and presented recommendations of the groups in a plenary session. The participants made a list of recommendations after extensive discussions. A Writing Committee was formed and was entrusted with the task of drawing a Consensus Statement on the basis of these Recommendations. After multiple deliberations, the following Consensus Statement was adopted. Objectives: To critically evaluate the current global evidence to formulate a consensus among stakeholders regarding diagnosis and management of SAM. Recommendations: An integrated management of malnutrition is likely to yield more dividends. Thus, management of SAM should constitute an important component of Integrated Management of Neonatal and Childhood Illnesses (IMNCI) program. Determination of SAM on the basis of Z-scores using WHO Growth charts is considered statistically more appropriate than cut-offs based on percentage weight deficit of the median. Considering the fact that many children with SAM can be successfully managed on outpatient basis and even in the community, it is no more considered necessary to advise admission of all children with SAM to a healthcare facility. Management of SAM should not be a stand-alone program. It should integrate with community management therapeutic programs and linkages with child treatment center, district hospitals and tertiary level centers offering inpatient management for SAM and include judicious use of ready-to-use-therapeutic Food (RUTF). All sections of healthcare providers need to be trained in the integrated management of SAM.

Overcoming Challenges to Accelerating Linear Growth in Indian Children.

This policy review highlights the need to focus on stunting as an indicator of under-five undernutrition and explores the major challenges and priority public health options for accelerating linear growth in children. Early childhood stunting predicts poor human capital including shorter adult height, lower attained schooling, reduced adult income, and decreased offspring birth weight. The current prevalence of stunting is disconcerting but there has been a relatively faster decline recently. It is imperative to intervene before birth to address stunting. Pertinent ongoing interventions (delaying early child birth, adequate antenatal care and maternal iron-folate supplementation) are beneficial but have sub-optimal coverage. There is only a narrow window of opportunity in early life – the first two years. Effective coverage of children below two years of age with a package of interventions (breastfeeding; immunization; appropriate complementary feeding; treatment of infections, especially diarrhea; safe water supply; and sanitation) merits urgent investigation for greater impact.

ICMR-DBT Guidelines for Evaluation of Probiotics in Food.

There has been an increased influx of probiotic products in the Indian market during the last decade. However, there has been no systematic approach for evaluation of probiotics in food to ensure their safety and efficacy. An initiative was, therefore, taken by the Indian Council of Medical Research (ICMR) along with the Department of Biotechnology (DBT) to formulate guidelines for regulation of probiotic products in the country. These guidelines define a set of parameters required for a product/strain to be termed as ‘probiotic’. These include identification of the strain, in vitro screening for probiotic characteristics, animal studies to establish safety and in vivo animal and human studies to establish efficacy. The guidelines also include requirements for labeling of the probiotic products with strain specification, viable numbers at the end of shelf life, storage conditions, etc., which would be helpful to the consumers to safeguard their own interest.

Neonatal Zinc Supplementation for Prevention of Mortality and Morbidity in Breastfed Low Birth Weight Infants: Systematic Review of Randomized Controlled Trials.

Objectives: To evaluate whether zinc supplements prevent mortality and morbidity in breastfed low birth weight infants. Methods: All randomized or qausi–randomized trials with individual or cluster allocation and using concurrent controls were included. Study population included LBW infants irrespective of gestational status who were exclusively or predominantly breastfed at the initiation of intervention. Intervention comprised zinc salts given as tablets or syrups orally to provide at least 1 RDA of elemental zinc for at least a period of 14 days, introduced within one month of birth. Electronic databases were searched irrespective of language and publication status. Findings: Three trials from developing countries met the inclusion criteria. Limited data did not indicate a reduced risk of mortality (1 trial, RR=1.11; 95% CI 0.57 to 2.18 at one year), hospitalization rate (1 trial, odds ratio 1.10; 95% CI 0.87 to 1.39), acute respiratory infection (1 trial), or diarrhea (2 trials). However, the trial reporting on mortality was not adequately powered for evaluating this outcome. There was no evidence of an increase in weight (3 trials) or height (2 trials) at either 6 months or one year of age, or of an increased risk of vomiting following zinc supplementation. Serum zinc levels at the end of intervention were significantly higher in the supplemented group (2 trials). Conclusions: In view of no convincing evidence of benefits from the limited data available, currently there is no justification for recommending routine zinc supplementation for breastfed LBW newborns in developing countries.

Consensus Statement: National Consensus Workshop on Management of SAM Children through Medical Nutrition Therapy.

Justification: Severe acute malnutrition (SAM) is an important preventable and treatable cause of morbidity and mortality in children below five years of age in India. The concerned stakeholders are not in agreement about the role of product based medical nutrition therapy in the management of this condition. Process: In November 2009, a National Consensus Workshop was organized by the Department of Human Nutrition, All India Institute of Medical Sciences, New Delhi in collaboration with the Department of Pediatrics and Clinical Epidemiology, Sitaram Bhartia Institute of Science and Research, New Delhi, and the Sub-specialty Chapter on Nutrition, Indian Academy of Pediatrics. Presentations by eminent national and international scientists, the ensuing discussions, and opinions expressed by the participants provided the basic framework for drafting the consensus statement. The draft of the consensus statement was circulated to all the participants; it underwent two revisions after consideration of their comments. Objectives: (i) Critically appraise the current global evidence on the utility of “Medical Nutrition Therapy” (MNT) for the management of SAM in under five children; (ii) Formulate a consensus amongst stakeholders regarding the need to introduce product based MNT for the management of SAM in under five children in India; (iii) Identify research priorities for MNT for the management of SAM in under five children in India; and (iv) Ascertain potential challenges for introducing product based MNT in India, if consensus opinion identifies such a need. Recommendations: Guidelines related to the role of MNT in management of children suffering from SAM are presented. Global and regional data document the effectiveness of MNT using ready-to-use therapeutic foods (RUTF) and locally formulated products. Adequate caution should be exercised to ensure that MNT for SAM does not interfere with measures for the holistic prevention of childhood undernutrition. Indian manufacture of RUTF is feasible, and can be scaled up. Product-based nutrition therapy including RUTF can be introduced on a pilot basis when a delivery design and plan of action is developed and is in place as a part of the larger system to deal with childhood undernutrition. RUTF should be used only as therapeutic and not supplementary feeding, above six months of age, and for a limited time period (4-8 weeks) until the child recovers from SAM, which should be defined in explicit treatment protocols. An urgent research issue is comparison of RUTF with home-based and locally-formulated products.

Efficacy of Short Course (<4 Days) of Antibiotics for Treatment of Acute Otitis Media in Children: A Systematic Review of Randomized Controlled Trials.

Objective: To determine the efficacy of a short course of antibiotics (<4 days) in comparison to a longer course (≥4 days) for the treatment of acute otitis media in children. Data sources: Electronic databases, hand search of reviews, bibliographies of books, abstracts and proceedings of international conferences. Review Methods: Randomized controlled trials of the empiric treatment of acute otitis media comparing antibiotic regimens of <4 days versus ≥4 days in children between four weeks to eighteen years of age were included. The trials were grouped by pharmacokinetic behavior of short-course antibiotics into short-acting antibiotics, parenteral ceftriaxone, and long-acting azithromycin. Results: We reviewed 35 trials, which provided 38 analytic components. Overall, there was no evidence of an increased risk of treatment failure until one month with a short-course of antibiotics (RR=1.06, 95% CI 0.95 to 1.17, P=0.298). Use of short-acting oral antibiotic in shortcourse was associated with a significantly increased risk of treatment failure (RR=2.27, 95% CI: 1.04 to 4.99). There was a slightly increased risk of treatment failure with parenteral ceftriaxone (RR=1.13, 95% CI 0.99 to 1.30). The risk of adverse effects was significantly lower with short-course regimens (RR=0.58, 95% CI: 0.48 to 0.70). Conclusion: There is no evidence of an increased risk of treatment failure with short course of antibiotics for acute otitis media. Among the short-course regimens, azithromycin use was associated with a lower risk of treatment failure while short-acting oral antibiotics and parenteral ceftriaxone may be associated with a higher risk of treatment failure.

Risks of routine iron and folic acid supplementation for young children.

Context: Almost 70% of young children in India are anemic. Current policy recommends routine iron-folic acid (IFA) supplementation to all under 5 children. A potential risk of this approach is an increase in infectious diseases in general, and malaria in particular. Evidence acquisition: An extensive literature search including PubMed, the World Health Organization (WHO) docu-ment library, and the Indian Government database, for documents regarding IFA supplementation in under-5 children. Results: Previously, systematic reviews had suggested adverse effects of IFA supplementation in malaria endemic settings. However, a recent large trial in Tanzania has found clear evidence of increased mortality, chiefly due to malaria, among children receiving routine IFA, whilst a simultaneous study in Nepal (a non-malarious region) found no adverse effects on morbidity or mortality from infectious disease attributable to IFA. These findings have prompted the World Health Organization to revise recommendations regarding IFA supplementation in malaria endemic areas. Conclusions: India has a non-homogenous distribution of malaria endemicity. We propose that although no change to IFA supplementation be made in non-malarious regions, routine IFA should be provided in malarious regions once malaria control and primary health care infrastructure are functioning well.