The Tools for Integrated Management of Childhood Illness (TIMCI) study protocol: a multi-country mixed-method evaluation of pulse oximetry and clinical decision support algorithms.

Effective and sustainable strategies are needed to address the burden of preventable deaths among children under-five in resource-constrained settings. The Tools for Integrated Management of Childhood Illness (TIMCI) project aims to support healthcare providers to identify and manage severe illness, whilst promoting resource stewardship, by introducing pulse oximetry and clinical decision support algorithms (CDSAs) to primary care facilities in India, Kenya, Senegal and Tanzania. Health impact is assessed through: a pragmatic parallel group, superiority cluster randomised controlled trial (RCT), with primary care facilities randomly allocated (1:1) in India to pulse oximetry or control, and (1:1:1) in Tanzania to pulse oximetry plus CDSA, pulse oximetry, or control; and through a quasi-experimental pre-post study in Kenya and Senegal. Devices are implemented with guidance and training, mentorship, and community engagement. Sociodemographic and clinical data are collected from caregivers and records of enrolled sick children aged 0-59 months at study facilities, with phone follow-up on Day 7 (and Day 28 in the RCT). The primary outcomes assessed for the RCT are severe complications (mortality and secondary hospitalisations) by Day 7 and primary hospitalisations (within 24 hours and with referral); and, for the pre-post study, referrals and antibiotic. Secondary outcomes on other aspects of health status, hypoxaemia, referral, follow-up and antimicrobial prescription are also evaluated. In all countries, embedded mixed-method studies further evaluate the effects of the intervention on care and care processes, implementation, cost and cost-effectiveness. Pilot and baseline studies started mid-2021, RCT and post-intervention mid-2022, with anticipated completion mid-2023 and first results late-2023. Study approval has been granted by all relevant institutional review boards, national and WHO ethical review committees. Findings will be shared with communities, healthcare providers, Ministries of Health and other local, national and international stakeholders to facilitate evidence-based decision-making on scale-up.Study registration: NCT04910750 and NCT05065320.

Pulse oximetry and clinical decision support algorithms show potential for supporting healthcare providers to identify and manage severe illness among children under-five attending primary care in resource-constrained settings, whilst promoting resource stewardship but scale-up has been hampered by evidence gaps.This study design article describes the largest scale evaluation of these interventions to date, the results of which will inform country- and global-level policy and planning .

Assessment of Blood Lead Level of School Children in 10 Cities of India: A Cross-Sectional Study.

OBJECTIVES: To assess the blood lead level (BLL) of school children in 10 cities of India. METHODS: This multi-centric cross-sectional study enrolled participants from randomly selected schools. Data on demographic details, socioeconomic status (SES) and anthropometric indicators was collected. Samples were collected for assessment of lead level in blood. Inductively coupled plasma-optical emission spectrometry technique was used to assess BLL. RESULTS: From April 2019 through February 2020, 2247 participants were recruited from sixty schools (62.6% government schools) with equal gender distribution. The overall median (interquartile range) BLL was 8.8 (4.8, 16.4) µg/dl. The highest median (interquartile range) BLL was in Manipal 30.6 (23.0, 46.7) and lowest in Dibrugarh 4.8 (3.2, 7.0). Overall, 82.5% of participants had BLL above ≤4 µg/dl. Significant negative correlation was observed between BLL and SES (correlation= -0.24, p <0.001), anthropometric indicators (correlation= -0.11, p <0.001), hemoglobin level (correlation= -0.045, p = 0.03) and multivariate regression model showed association with gender, SES and anthropometric indicators. CONCLUSIONS: BLL are elevated in urban school going children and there is intercity variation. Hence, urgent focus is needed to reduce exposure to lead in India.

Association of dietary intake with micronutrient deficiency in Indian school children: a cross-sectional study.

Adequate nutrition is necessary during childhood and early adolescence for adequate growth and development. Hence, the objective of the study was to assess the association between dietary intake and blood levels of minerals (calcium, iron, zinc, and selenium) and vitamins (folate, vitamin B12, vitamin A, and vitamin D) in urban school going children aged 6-16 years in India, in a multicentric cross-sectional study. Participants were enrolled from randomly selected schools in ten cities. Three-day food intake data was collected using a 24-h dietary recall method. The intake was dichotomised into adequate and inadequate. Blood samples were collected to assess levels of micronutrients. From April 2019 to February 2020, 2428 participants (50⋅2 % females) were recruited from 60 schools. Inadequate intake for calcium was in 93⋅4 % (246⋅5 ± 149⋅4 mg), iron 86⋅5 % (7⋅6 ± 3⋅0 mg), zinc 84⋅0 % (3⋅9 ± 2⋅4 mg), selenium 30⋅2 % (11⋅3 ± 9⋅7 mcg), folate 73⋅8 % (93⋅6 ± 55⋅4 mcg), vitamin B12 94⋅4 % (0⋅2 ± 0⋅4 mcg), vitamin A 96⋅0 % (101⋅7 ± 94⋅1 mcg), and vitamin D 100⋅0 % (0⋅4 ± 0⋅6 mcg). Controlling for sex and socioeconomic status, the odds of biochemical deficiency with inadequate intake for iron [AOR = 1⋅37 (95 % CI 1⋅07-1⋅76)], zinc [AOR = 5⋅14 (95 % CI 2⋅24-11⋅78)], selenium [AOR = 3⋅63 (95 % CI 2⋅70-4⋅89)], folate [AOR = 1⋅59 (95 % CI 1⋅25-2⋅03)], and vitamin B12 [AOR = 1⋅62 (95 %CI 1⋅07-2⋅45)]. Since there is a significant association between the inadequate intake and biochemical deficiencies of iron, zinc, selenium, folate, and vitamin B12, regular surveillance for adequacy of micronutrient intake must be undertaken to identify children at risk of deficiency, for timely intervention.

Micronutrients and cognitive functions among urban school-going children and adolescents: A cross-sectional multicentric study from India.

BACKGROUND: Micronutrient deficiency (MD) is associated with deficits in cognitive functioning of children. However, no comprehensive multicentric study has been conducted in India to explore the role of multiple MD in cognition of children and adolescents. The present study aimed to explore association of MD with level of general intelligence and specific cognitive functions, in urban school-going children and adolescents across ten cities of India. METHOD: Cross-sectional multicentric study, enrolled participants aged 6-16 years. Blood samples were collected for biochemical analysis of calcium, iron, zinc, selenium, folate, vitamin A, D and B12. Colored Progressive Matrices / Standard Progressive Matrices (CPM/SPM), Coding, Digit Span and Arithmetic tests were used for the assessment of cognitive functions of participants. Height and weight measures were collected along with socio-economic status. RESULTS: From April-2019 to February-2020, 2428 participants were recruited from 60 schools. No MD was found in 7.0% (134/1918), any one MD in 23.8% (457/1918) and ≥ 2 MD in 69.2% (1327/1918) participants. In presence of ≥ 2 MD, adjusted odds ratio (OR) for borderline or dull normal in CPM/SPM was 1.63, (95% CI: 1.05-2.52), coding was 1.66 (95% CI: 1.02-2.71), digit span was 1.55 (95% CI: 1.06-2.25) and arithmetic was 1.72 (95% CI: 1.17-2.53), controlling for gender, socioeconomic status and anthropometric indicators. CONCLUSION: Since ≥ 2 MD were found in more than 2/3rd of participants and was associated with impairment in cognitive function, attempts must be made to ameliorate them on priority in school going children in India. TRIAL REGISTRATION NUMBER: CTRI/2019/02/017783.

Prevalence of specific micronutrient deficiencies in urban school going children and adolescence of India: A multicenter cross-sectional study.

INTRODUCTION: Childhood and adolescence require adequate amount of micronutrients for normal growth and development. The primary objective of study was to assess the prevalence of deficiencies of Vitamins (Vitamin A, 25 Hydroxy Vitamin D, Vitamin B12 and Folate) and minerals (Calcium, Zinc, Selenium and Iron), among urban school going children aged 6-11 and 12-16 years in ten cities of India. Secondary objective was to find the association between micronutrient deficiencies with sociodemographic and anthropometric indicators. METHODS: A multi-center cross-sectional study was conducted across India. Participants in the age groups of 6 to 11 years (group 1) and 12 to 16 years (group 2) were selected from randomly chosen schools from each center. Data on socio economic status, anthropometric measures was collected. Blood samples were collected for biochemical analysis of micronutrients. Point estimates and 95% confidence intervals was used to assess the prevalence of deficiencies. Associations were observed using chi square, student t test and ANOVA test. RESULTS: From April 2019 to February 2020, 2428 participants (1235 in group 1 and 1193 group 2) were recruited from 60 schools across ten cites. The prevalence of calcium and iron deficiency was 59.9% and 49.4% respectively. 25 Hydroxy Vitamin D deficiency was seen in 39.7% and vitamin B12 in 33.4% of subjects. Folate, Selenium and Zinc were deficient in 22.2%, 10.4% and 6.8% of subjects respectively. Vitamin A deficiency least (1.6%). Anemia was prevalent in 17.6% subjects and was more common among females. CONCLUSION: One or more micronutrient deficiencies are found in almost one half of school going children in urban area. Hence efforts must be made to combat these on priority. TRIAL REGISTRATION NUMBER: CTRI/2019/02/017783.

Prevalence of specific micronutrient deficiencies in urban school going children of India aged between 6 and 16 years: study protocol for a multicentric cross-sectional study.

INTRODUCTION: Childhood and adolescence are the period of rapid physical and cognitive growth and development, requiring adequate nutrition. Malnutrition in the form of undernutrition or micronutrient deficiency or overweight/obesity affects the health, cognition and educational achievement of this age group. The objective of this study is to assess the prevalence of calcium, iron, zinc, selenium, folate, vitamin A, 25 hydroxy vitamin D and vitamin B12 deficiencies in the serum and haemoglobin, ferritin and lead levels and its association with reported dietary intake and cognitive abilities, in urban school going children aged 6-16 years in 10 cities of India. METHODS AND ANALYSIS: A multicentric cross-sectional study will be conducted to recruit 2400 participants (240 per site) across India. Participants will be selected using random sampling and will be categorised into age groups of 6-11 years and 12-16 years, with equal distribution. Data on socioeconomic status, anthropometric measures and 3-day dietary intake and cognitive performance will be collected. Blood samples will be collected for biochemical analysis of micronutrients. Findings will estimate the prevalence of micronutrient deficiencies and their association with dietary habits and cognitive functioning. ETHICS AND DISSEMINATION: Study protocol has been reviewed and approved by institutional ethics committee of all 10 participating sites. Results will be shared and published in a peer-reviewed journal, so that the findings will be helpful for the stakeholders in planning nutritional interventions for targeted groups. TRIAL REGISTRATION NUMBER: CTRI/2019/02/017783.

Effectiveness of various communication strategies for improving childhood pneumonia case management: a community based behavioral open labeled trial in rural Lucknow, Uttar Pradesh, India.

BACKGROUND: Community acquired pneumonia is responsible for 16% of under 5 mortality in India, probably due to delayed recognition and qualified care seeking. Therefore these deaths could possibly be averted by creating community awareness and promoting care seeking from qualified physicians in the government system. The objective of study was to assess the effectiveness of facility-based and village-based behavior change communication interventions delivered to community using validated information, education and communication materials, along with infrastructural strengthening of health facilities, for change in care seeking from government system for community acquired pneumonia in rural Lucknow, India. METHOD: Community based open labeled behavioral trial in 2 by 2 factorial design was conducted in eight rural blocks of Lucknow, northern India. Trained community health workers conducted Pneumonia Awareness Sessions once a month for the care givers of children using validated information, education and communication materials either at the villages or at government health facilities. Prior infrastructural strengthening of public health facilities was done to provide optimal care to cases. Pre packed pneumonia drug kits were provided which had amoxicillin, paracetamol and an instruction card on their use as well as pictorial representation of danger signs of pneumonia. RESULTS: Study lasted from October 2015 to September 2018. Adherence to conduct of facility-based intervention was 93.0% (279/300) and to village-based intervention was 73.4% (7638/10410). In village-based intervention there was 79.3% (p < 0.0001) increase from a baseline of 3.3% (14/420) and facility-based intervention 68.9% (p = 0.02) increase from a baseline of 5.35% (21/392) in cases of possible pneumonia treated at government health facilities. CONCLUSION: Conduct of structured pneumonia awareness session using validated information, education and communication material at village level with infrastructural strengthening resulted in improved qualified care seeking from government facilities for community acquired pneumonia. TRIAL REGISTRATION: AEARCTR-0003137, retrospectively registered on 10/July/2018.