Air pollution is a significant global health concern, with studies from the USA and Europe linking long-term exposure to respiratory issues and poor school attendance in children. While Indian cities experience much higher pollution levels, the impact on lung development in Indian children remains unclear. This study aims to assess the burden of impaired lung function in Indian children and identify key factors contributing to pollution-induced lung injury.

This longitudinal, prospective cohort study is conducted in four cities categorised by particulate matter 2.5 (PM_2.5) levels: ‘very high’ (Delhi), ‘high’ (Mumbai, Bangalore) and ‘moderate’ (Mysore). A total of 4000 participants (1000 from each city) will be included in the study. Participants will complete a structured questionnaire covering sociodemographics, asthma and allergy history (International Study of Asthma and Allergies in Childhood core questionnaire), dietary intake (24-hour recall and Food Frequency Questionnaire), Physical Activity-C Questionnaire and air pollution exposure. Spirometry and Forced Oscillation Technique will be used to assess lung function. Blood samples will be collected for identification of biomarkers to predict lung impairment. After quality checks, data will be compiled, summarising pulmonary function parameters alongside covariates and confounders. Analysis of Variance (ANOVA) will assess between-city and within-city differences in lung function.

We anticipate a higher prevalence of reduced lung function in children residing in cities with very high and high PM_2.5 levels compared with the moderately polluted city. Findings from this study could establish normal age-appropriate lung function reference values for Indian urban children, aiding in clinical diagnosis.If a reliable biomarker for identifying children at risk of lung impairment is available, it could serve as an early predictor of poor lung health in asymptomatic children.

The approval from individual site institutional review board (IRB) is obtained prior to initiation of the study from institutional ethics committee, St. John’s Medical College and Hospital, Bangalore; institutional ethics committee, JSS Medical College, Mysore; institute ethics committee, Indian Institute of Technology Bombay and institute ethics committee, All India Institute of Medical Sciences. Findings from this study will be disseminated through conference presentations, peer-reviewed publications and establishment of normal age-appropriate lung function reference values for children living in urban India.

Perinatal care continuity across the full continuum is essential for optimising maternal and infant health; however, a stark gap occurs post partum, with less than one half of Indian mothers receiving postpartum care due to significant logistical and sociocultural barriers, particularly for periurban and rural residents. To overcome these barriers and reduce women’s postpartum isolation, our international team of maternal and infant health clinicians and researchers developed and pilot-tested a culturally-tailored mobile interactive education and support group intervention, Kushal Maa (‘informed-mother’), confirming feasibility and acceptability and preliminary effectiveness. The current study seeks to estimate the effectiveness of the Kushal Maa intervention compared with standard care on maternal and neonatal health-related behaviours and health, characterise the mechanisms of intervention impact and evaluate the cost-effectiveness of the Kushal Maa intervention in improving postpartum maternal and neonatal health compared with the standard of care.

We will conduct a prospective, parallel block-randomised controlled trial with a 1:1 allocation ratio among 2100 pregnant women across three geographically diverse Indian states. Inclusion criteria for women: aged 18+years of age at enrolment, in the last trimester of pregnancy (30–33 weeks of gestation), with any parity, carrying single or multiple gestation (1-2), with knowledge of site-specific local language and had access to a mobile phone. Participants will be block-randomised in groups of 15. Intervention participants will receive 28 tailored education and support sessions weekly via audio/video conference facilitated by trained moderators (four prenatal and 24 weekly postpartum sessions through 6 months) and will be engaged in WhatsApp groups for health education videos and peer discussion via text chat. Control participants receive the standard of care. Data will be collected at four points: 30–33 weeks of pregnancy (enrolment), 6 weeks, 3 months and 6 months postpartum (endline). Investigators, outcome assessors and data analysts will be blinded to group allocation. Primary outcomes will be measured at 6 weeks, 3 months and 6 months post partum and include: postpartum depression (using Edinburgh Postnatal Depression Scale), exclusive breastfeeding and met need for postpartum family planning. Secondary outcomes include other maternal and child health knowledge, outcomes and maternal and newborn healthcare use indicators. We will use intention-to-treat analysis. Mixed-effects models will account for clustering due to the group-oriented delivery of the intervention and repeated measures.

This study has been approved by the Health Ministry Screening Committee, Government of India and approved by ethics boards at the Post-Graduate Institute for Medical Education and Research, Chandigarh (Ref:001208, IEC-06/2022–2471), Maharashtra University of Health Sciences (Ref: MUHS/EC/06/2024), Sangath (Ref: AB_2022_81) and the University of California, San Francisco (Ref: 21–35730). All research activities will be performed in accordance with the Declaration of Helsinki. On completion, findings will be disseminated to stakeholders through diverse strategies. Results will be published in academic journals and presented at conferences.

ClinicalTrials.gov: NCT05268588 Clinical Trials Registry – India: CTRI/2022/07/043889.

Treating modifiable risk factors of dementia may prevent or delay dementia cases by up to 40%. The ‘Strategic Multimodal Intervention in at-risk Elderly Indians for Prevention of Dementia (SMRUTHI INDIA)’ study will be conducted to establish a trial-ready cohort of elderly Indians who are at high risk of developing dementia.

The main aim of the study is to create and study a cohort of individuals at high risk of dementia in rural India, where we can do multiple intervention trials. The study uses the ‘Cohort Multiple Randomised Controlled Trial’ (cmRCT) design, which combines a cohort study with in-built provisions to do multiple randomised controlled trials. A large rural cohort of size 10 000 (four zones of India, through established Indian Council of Medical Research - Model Rural Health Research Units) will be followed systematically with yearly neuropsychological evaluation for 5 years (the current funding supports first 3000 participants). The study also proposes to design a multimodal ‘care bundle’ for the prevention of dementia, which is culturally tailored and context-specific to the Indian population. This intervention will undergo testing for feasibility in the hospital setting at the central coordinating site through a pilot randomised controlled trial (6 months, 30 participants). In parallel, the care bundle will be culturally and linguistically adapted and pilot-tested in 20 participants in each zone. The final curated care bundle (first intervention that is planned) will then be tested for efficacy in phase 2 of the SMRUTHI INDIA cmRCT cohort.

The study has received ethical clearance at the central coordinating site and at each of the four clinical sites by the Institute Research Committee of each site. The outcomes of the study will be disseminated to various target audiences, including research participants, general public, scientific community and policy makers through national and international conferences and events, social media, various community engagement activities and publication in peer-reviewed journals.

The study protocol is registered in the Clinical Trial Registry of India (CTRI/2024/01/061172).

Antenatal corticosteroid (ACS) regimens have remained unchanged since the initial trials in 1972, with the optimal regimen still undetermined. The WHO ACTION (Antenatal CorticosTeroids for Improving Outcomes in preterm Newborns)-III trial is a three-arm individually randomised double-blind trial evaluating the efficacy and safety of two different ACS dosing regimens (currently used and lower-dose ACS regimens vs placebo) in women with a high probability of having a late preterm birth. This study protocol nested within this trial aims to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) effects of two different ACS dosing regimens in pregnant women in the late preterm period (34–36 weeks) to help inform an optimal dosing regimen.

The study will be conducted in two of the five countries participating in the WHO ACTION-III trial—India (Delhi, Belagavi) and Nigeria (Ibadan and Ile-Ife). We will use a population PK approach using sparse sampling to study the PK effects of the two ACS regimens, that is, 6 mg dexamethasone phosphate (DEXp) or 2 mg betamethasone phosphate (BETp), administered intramuscularly every 12 hours for a maximum of four doses or till birth, whichever is earlier, compared with placebo. We will also ascertain the fetal–maternal ratio of DEXp and BETp at birth.

Maternal venous blood samples will be collected at 0, 1–4 hours, 8–12 hours after the first dose, and at 24–36 hours, 48–60 hours, 72–96 hours after the last dose, and immediately after birth, along with cord blood. Concentrations of DEXp and BETp will be measured at set time points using a validated liquid chromatography mass spectroscopy assay. PD parameters measured will include total and differential white blood cell count (by automated analysers using electrical impedance), plasma glucose (hexokinase method) and serum cortisol (using a validated electrochemiluminescence immunoassay), at predefined time points. PK models will be developed for each drug using non-linear mixed effects methods. Optimal dosing will be investigated using Monte Carlo simulations.

The study has been approved by the WHO Ethics Review Committee and the site-specific ethics committees of the participating leading institutions. Written informed consent will be obtained from all participants. The study results will be published in a peer-reviewed journal and presented at scientific conferences.

ISRCTN11434567.