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Background/Objectives: Two compartment (2 C) models of body composition, including Air Displacement Plethysmography (ADP) and Deuterium Dilution (DD), assume constant composition of fat-free mass (FFM), while 3-compartment (3 C) model overcomes some of these assumptions; studies are limited in infants. The objective of the present study is to compare 3 C estimates of body composition in 6-mo. old infants from Australia, India, and South Africa, including FFM density and hydration, compare with published literature and to evaluate agreement of body composition estimates from ADP and DD. Methods: Body volume and water were measured in 176 healthy infants using ADP and DD. 3C-model estimates of fat mass (FM), FFM and its composition were calculated, compared between countries (age and sex adjusted) and with published literature. Agreement between estimates from ADP and DD were compared by Bland–Altman and correlation analyses. Results: South African infants had significantly higher % FM (11.5%) and density of FFM compared to Australian infants. Australian infants had significantly higher % FFM (74.7 ± 4.4%) compared to South African infants (71.4 ± 5.0) and higher FFMI (12.7 ± 0.8 kg/m2) compared to South African (12.3 ± 1.2 kg/m2) and Indian infants (11.9 ± 1.0 kg/m2). FFM composition of present study differed significantly from literature. Pooled three country estimates of FM and FFM were comparable between ADP and DD; mean difference of −0.05 (95% CI: −0.64, +0.55) kg and +0.05 (95% CI: −0.55, +0.64) kg. Conclusions: 3C-model estimates of body composition in infants differed between countries; future studies are needed to confirm these findings and investigate causes for the differences. [ABSTRACT FROM AUTHOR]

Objective To estimate neonatal mortality, particularly within 24 hours of birth, in six low- and lower-middle-income countries. Methods We analysed epidemiological data on a total of 149 570 live births collected between 2007 and 2013 in six prospective randomized trials and a cohort study from predominantly rural areas of Bangladesh, Ghana, India, Pakistan, the United Republic of Tanzania and Zambia. The neonatal mortality rate and mortality within 24 hours of birth were estimated for all countries and mortality within 6 hours was estimated for four countries with available data. The findings were compared with published model-based estimates of neonatal mortality. Findings Overall, the neonatal mortality rate observed at study sites in the six countries was 30.5 per 1000 live births (range: 13.6 in Zambia to 47.4 in Pakistan). Mortality within 24 hours was 14.1 per 1000 live births overall (range: 5.1 in Zambia to 20.1 in India) and 46.3% of all neonatal deaths occurred within 24 hours (range: 36.2% in Pakistan to 65.5% in the United Republic of Tanzania). Mortality in the first 6 hours was 8.3 per 1000 live births, i.e. 31.9% of neonatal mortality. Conclusion Neonatal mortality within 24 hours of birth in predominantly rural areas of six low- and lower-middle-income countries was higher than model-based estimates for these countries. A little under half of all neonatal deaths occurred within 24 hours of birth and around one third occurred within 6 hours. Implementation of high-quality, effective obstetric and early newborn care should be a priority in these settings [ABSTRACT FROM AUTHOR]

Background: Accurate assessment of body composition during infancy is an important marker of early growth. This study aimed to develop anthropometric models to predict body composition in 3-24-month-old infants from diverse socioeconomic settings and ethnic groups., Methods: An observational, longitudinal, prospective, multi-country study of infants from 3 to 24 months with body composition assessed at three monthly intervals using deuterium dilution (DD) and anthropometry. Linear mixed modelling was utilized to generate sex-specific fat mass (FM) and fat-free mass (FFM) prediction equations, using length(m), weight-for-length (kg/m), triceps and subscapular skinfolds and South Asian ethnicity as variables. The study sample consisted of 1896 (942 measurements from 310 girls) training data sets, 941 (441 measurements from 154 girls) validation data sets of 3-24 months from Brazil, Pakistan, South Africa and Sri Lanka. The external validation group (test) comprised 349 measurements from 250 (185 from 124 girls) infants 3-6 months of age from South Africa, Australia and India., Results: Sex-specific equations for three age categories (3-9 months; 10-18 months; 19-24 months) were developed, validated on same population and externally validated. Root mean squared error (RMSE) was similar between training, validation and test data for assessment of FM and FFM in boys and in girls. RMSPE and mean absolute percentage error (MAPE) were higher in validation compared to test data for predicting FM, however, in the assessment of FFM, both measures were lower in validation data. RMSE for test data from South Africa (M/F-0.46/0.45 kg) showed good agreement with validation data for assessment of FFM compared to Australia (M/F-0.51/0.33 kg) and India(M/F-0.77/0.80 kg)., Conclusions: Anthropometry-based FFM prediction equations provide acceptable results. Assessments based on equations developed on similar populations are more applicable than those developed from a different population., (© 2024. The Author(s).)

Background: Given the importance of infancy for establishing growth trajectories, with later-life health consequences, we investigated longitudinal body composition among infants from six economically and ethnically diverse countries., Methods: We recruited mother-infant dyads using the WHO Multicenter Growth Reference Study criteria. We measured fat-free mass (FFM) in 1393 (49% female) infants from birth to 6 months of age (Australia, India, and South Africa; n = 468), 3-24 months of age (Brazil, Pakistan, South Africa, and Sri Lanka; n = 925), and derived fat mass (FM), fat mass index (FMI), and fat-free mass index (FFMI). Height-for-age (HAZ), weight-for-age (WAZ), and weight-for-length (WHZ) Z-scores were computed. Sex differences were assessed using a t-test, and country differences using a one-way analysis of covariance. We further compared subsamples of children with average (-0.25 > HAZ < +0.25), below-average (≤-0.25) and above-average (≥+0.25) HAZ., Results: HAZ performed well between 0 and 6 months, but less so between 3 and 24 months. The stunting prevalence peaked at 10.3% for boys and 7.8% for girls, at 24 months. By 24 months, girls had greater FMI (10%) than boys. There were significant differences in FFM (both sexes in all countries) and FM (Brazilian boys, Pakistani and South African girls) by 24 months of age between infants with average, above-average, and below-average HAZ., Conclusion: In a multi-country sample representing more ideal maternal conditions, body composition was heterogeneous even among infants who exhibited ideal length. Having a mean HAZ close to the median of the WHO standard for length reduced FFM between-country heterogeneity but not FM, suggesting that other factors may influence adiposity., (© 2024. The Author(s).)

Background/objective: Available evidence on infant body composition is limited. This study aimed to investigate factors associated with body composition at 6 and 24 months., Subjects/methods: Multicenter study with data from a 0 to 6-mo cohort (Australia, India and South Africa) and a 3 to 24-mo cohort (Brazil, Pakistan, South Africa, and Sri Lanka). For the 0-6-mo cohort, body composition was assessed by air-displacement plethysmography (ADP) and for the 3-24-month cohort by the deuterium dilution (DD) technique. Fat mass (FM), fat-free mass (FFM), FM index (FMI), and FFM index (FFMI) were calculated. Independent variables comprised the Gini index of the country, maternal and infant characteristics, and breastfeeding pattern at 3 months. For the 3-24-mo cohort, breastfeeding, and minimum dietary diversity (MDD) at 12 months were also included. Crude and adjusted analyses stratified by sex were conducted by multilevel modelling using mixed models., Results: At 6 months, every 1 kg increase in birth weight was associated with an increase of 0.716 kg in FFM and 0.582 kg/m 2 in FFMI in girls, whereas in boys, the increase was of 0.277 kg in FFM. At 24 months, compared to those weaned before 12 months, girls still breastfed at 12 months presented a decrease of 0.225 kg in FM, 0.645 kg in FFM and 0.459 kg/m 2 in FFMI, and in boys the decreases were of 0.467 kg in FM, 0.603 kg in FFM and 0.628 kg/m 2 in FFMI., Conclusion: Birth weight and breastfeeding are independent predictors of body composition in early life, irrespective of sex., (© 2023. The Author(s).)

Introduction: Research on simplified antibiotic regimens for outpatient treatment of 'Possible Serious Bacterial Infection' (PSBI) and the subsequent World Health Organization (WHO) guidelines provide an opportunity to increase treatment coverage. This multi-country implementation research initiative aimed to learn how to implement the WHO guideline in diverse contexts. These experiences have been individually published; this overview paper provides a summary of results and lessons learned across sites., Methods Summary: A common mixed qualitative and quantitative methods protocol for implementation research was used in eleven sites in the Democratic Republic of Congo (Equateur province), Ethiopia (Tigray and Oromia regions), India (Haryana, Himachal Pradesh, Maharashtra, and Uttar Pradesh states), Malawi (Central Region), Nigeria (Kaduna and Oyo states), and Pakistan (Sindh province). Key steps in implementation research were: i) policy dialogue with the national government and key stakeholders, ii) the establishment of a 'Technical Support Unit' with the research team and district level managers, and iii) development of an implementation strategy and its refinement using an iterative process of implementation, programme learning and evaluation., Results Summary: All sites successfully developed and evaluated an implementation strategy to increase coverage of PSBI treatment. During the study period, a total of 6677 young infants from the study catchment area were identified and treated at health facilities in the study area as inpatients or outpatients among 88179 live births identified. The estimated coverage of PSBI treatment was 75.7% (95% CI 74.8% to 78.6%), assuming a 10% incidence of PSBI among all live births. The treatment coverage was variable, ranging from 53.3% in Lucknow, India to 97.3% in Ibadan, Nigeria. The coverage of inpatient treatment ranged from 1.9% in Zaria, Nigeria, to 33.9% in Tigray, Ethiopia. The outpatient treatment coverage ranged from 30.6% in Pune, India, to 93.6% in Zaria, Nigeria. Overall, the case fatality rate (CFR) was 14.6% (95% CI 11.5% to 18.2%) for 0-59-day old infants with critical illness, 1.9% (95% CI 1.5% to 2.4%) for 0-59-day old infants with clinical severe infection and 0.1% for fast breathing in 7-59 days old. Among infants treated as outpatients, CFR was 13.7% (95% CI 8.7% to 20.2%) for 0-59-day old infants with critical illness, 0.9% (95% CI 0.6% to 1.2%) for 0-59-day old infants with clinical severe infection, and 0.1% for infants 7-59 days old with fast breathing., Conclusion: Important lessons on how to conduct each step of implementation research, and the challenges and facilitators for implementation of PSBI management guideline in routine health systems are summarised and discussed. These lessons will be used to introduce and scale-up implementation in relevant Low- and middle-income countries., Competing Interests: The authors declare that no competing interests exist. Some of the authors are currently and/or were previously employed by not-for-profit organizations including: Save the Children, World Health Organization, BMGF, USAID, UNICEF, and ActionAid. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

Background: Typhoid vaccination is a public health priority in developing countries where young children are greatly affected by typhoid fever. Because present vaccines are not recommended for children younger than 2 years, the Novartis Vaccines Institute for Global Health developed a conjugate vaccine (Vi-CRM197) for infant immunisation. We aimed to assess the immunogenicity and safety of Vi-CRM197 in participants of various ages in endemic countries in south and southeast Asia., Methods: We did two randomised, observer-blind, age de-escalation, phase 2 trials at two sites in Pakistan and India (study A), and at one site in the Philippines (study B), between March 2, 2011, and Aug 9, 2012. Adults aged 18-45 years, children aged 24-59 months, older infants aged 9-12 months, and infants aged 6-8 weeks were randomly assigned (1:1) with a computer-generated randomisation list (block size of four) to receive either 5 μg Vi-CRM197 or 25 μg Vi-polysaccharide vaccine (or 13-valent pneumococcal conjugate vaccine in children younger than 2 years). Both infant populations received Vi-CRM197 concomitantly with vaccines of the Expanded Programme on Immunization (EPI), according to WHO schedule. With the exception of designated study site personnel responsible for vaccine preparation, study investigators, those assessing outcomes, and data analysts were masked to treatment allocation. We specified no a-priori null hypothesis for the immunogenicity or safety objectives and all analyses were descriptive. Analyses were by modified intention-to-treat. These studies are registered with ClinicalTrials.gov, numbers NCT01229176 and NCT01437267., Findings: 320 participants were enrolled and vaccinated in the two trials: 200 in study A (all age groups) and 120 in study B (children and infants only), of whom 317 (99%) were included in the modified intention-to-treat analysis. One dose of Vi-CRM197 significantly increased concentrations of anti-Vi antibody in adults (from 113 U/mL [95% CI 67-190] to 208 U/mL [117-369]), children (201 U/mL [138-294] to 368 U/mL [234-580]), and older infants (179 U/mL [129-250] to 249 U/mL [130-477]). However, in children and older infants, a second dose of conjugate vaccine had no incremental effect on antibody titres and, at all ages, concentrations of antibodies increased substantially 6 months after vaccination (from 55 U/mL [33-94] to 63 U/mL [35-114] in adults, from 23 U/mL [15-34] to 51 U/mL [34-76] in children, and from 21 U/mL [14-31] to 22 U/mL [14-33] in older infants). Immune response in infants aged 6-8 weeks was lower than that in older participants and, 6 months after third vaccination, antibody concentrations were significantly higher than pre-vaccination concentrations in Filipino (21 U/mL [16-28] vs 2.88 U/mL [1.95-4.25]), but not Pakistani (3.76 U/mL [2.77-5.08] vs 2.77 U/mL [2.1-3.66]), infants. Vi-CRM197 was safe and well tolerated and did not induce any significant interference with EPI vaccines. No deaths or vaccine-related serious adverse events were reported throughout the studies., Interpretation: Vi-CRM197 is safe and immunogenic in endemic populations of all ages. Given at 9 months of age, concomitantly with measles vaccine, Vi-CRM197 shows a promise for potential inclusion in EPI schedules of countries endemic for typhoid. An apparent absence of booster response and a reduction in antibody titres 6 months after immunisation should be further investigated, but data show that an immunogenic typhoid vaccine can be safely delivered to infants during EPI visits recommended by WHO., Funding: Sclavo Vaccines Association and Regione Toscana., (Copyright © 2014 Elsevier Ltd. All rights reserved.)