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Background: Melghat in India is a hilly, forested, difficult to access, impoverished rural area in northeast part of Maharashtra (Central India) with difficult healthcare access. Melghat has very high Mortality rates, because of grossly inadequate medical facilities. (1) Home deaths contribute to 67% of deaths,(2) which are difficult to track and where cause of death is mostly unknown. Methods: A feasibility study was carried out in 93 rural villages and 5 hospitals to assess feasibility of tracking real-time community mortality and to ascertain cause of death in 0–60 months and 16–60 years age group using Minimal Invasive Tissue Sampling (MITS) in purpose-modified ambulance. We used the network of village health workers (VHW)s, to establish real-time community mortality tracking. Upon receipt of reports of home death, we performed MITS within 4 h of death in the vicinity of the village. Results: We conducted 16 MITS. Nine, in MITS ambulance in community and seven at MAHAN hospital. The acceptance rate of MITS was 59.26%. Standard operating procedure (SOP) of conducting community MITS in an ambulance, is established. Major challenges were, Covid19 lockdown, reluctance of tribal parents for consent for MITS due to illiteracy, superstitions and fear of organ removal. Ambulance was an easy to reach transport means in remote area, provided a well-designed and discrete facility to perform MITS in community, winning the confidence of bereaved family. This has reduced time interval between time of death and performing MITS. Conclusions: MITS in purpose-modified Ambulance can be used worldwide for community MITS especially in areas which are remote and lack healthcare access. This solution needs to be assessed in different cultural settings to document culture specific issues. [ABSTRACT FROM AUTHOR]

Background: Information on exact causes of death and stillbirth are limited in low and middle income countries. Minimally invasive tissue sampling (MITS) is increasingly practiced in place of autopsy across several settings. A formative research documented the experiences of counselling and consenting for MITS in north India. Methods: This exploratory qualitative study was conducted at a tertiary care hospital in Delhi. During the early implementation of MITS, observations of the counselling and consenting process (n = 13) for under-five child death and stillbirths were conducted. In-depth interviews with MITS team members (n = 3) were also conducted. Observation and interview data were transcribed and inductively analysed using thematic content analysis to identify emerging themes and codes. Results: The MITS team participated in daily ward rounds for familiarisation with parents/families. Following death declaration the counselling was done in counselling corner of the ward or adjacent corridor. Mostly the counselling was targeted at the father and family members present, using verbal explanation and the consent document in local language. The key concerns raised by parents/family were possible disfigurement, time needed and possible benefits. Most of the parents consulted family members before consent. Among those who consented, desire for next pregnancy, previous pregnancy or neonatal loss and participation of treating senior doctor were the key factors. The negative experience of hospital care, poor comprehension and distance from residence were the factors for consent refusal. Lesser number of parents of deceased children consented for MITS compared to the neonates and stillbirths. Conclusions: The initial experiences of obtaining consent for MITS were encouraging. Consent for MITS may be improved with active involvement of the treating doctors and nurses, better bereavement support, private counselling area along with improvement in quality of care and communication during hospitalisation. Special efforts and refinement in counselling are needed to improve consent for MITS in older children. Plain English summary: Information about exact cause of death and stillbirth are essential for appropriate care of children and pregnant women. Autopsy assists in establishing exact cause of death, but not preferred by the parents/families. Minimally invasive tissue sampling (MITS) is a suitable alternate to autopsy for establishing causes of death and stillbirth. A pilot project on MITS was initiated at a tertiary care hospital in north India (New Delhi). An exploratory formative research was conducted to document the experiences of counselling and consenting for MITS. Under this study, observation of the counselling and consenting process for conduct of MITS in under-five children (including neonates) and stillbirths were done. Additionally, in-depth interviews with MITS team members were also conducted. Counselling for MITS was done in one corner of the ward or adjacent corridor and mostly targeted at the father and family members present. Counselling was primarily verbal explanation in local language. The key concerns from parents/family were disfigurement, time needed and possible benefits. Most of the parents consulted family members before decision. Benefit during next pregnancy, past previous pregnancy or neonatal loss and senior treating doctor's involvement were key factors for consent. Poor quality of care and comprehension were the reasons for refusal. [ABSTRACT FROM AUTHOR]

Background: Minimal invasive tissue sampling (MITS) has emerged as a suitable alternative to complete diagnostic autopsy (CDA) for determination of the cause of death (CoD), due to feasibility and acceptability issues. A formative research was conducted to document the perceptions of parents, community and religious leaders on acceptability of MITS. Methods: This qualitative study was conducted at and around the Safdarjung Hospital, Delhi, India. Participants for in-depth interview included the parents who had either child or neonatal death or stillbirth and the key community and religious representatives. The focus group discussions (FGDs) involved community members. Process of obtaining consent for MITS was observed. Data were analyzed inductively manually for emerging themes and codes. Results: A total of 104 interviews (parents of deceased children, neonates or stillbirths, n = 93; community members, n = 8 and religious leaders, n = 7), 8 FGDs (n = 72) were conducted and process of obtaining consent for MITS (n = 27) was observed. The participants were positive and expressed willingness to accept MITS. The key determinants for acceptance of MITS were: (1) understanding and willingness to know the cause of death or stillbirth, (2) experience of the healthcare received and trust, (3) the religious and sociocultural norms. Parents and community favored for MITS over CDA when needed, especially where in cases with past stillbirths and child deaths. The experience of treatment, attitude and communication from healthcare providers emerged as important for consent. The decision making process was collective involving the elders and family. No religious leader was against the procedure, as both, the respect for the deceased and need for medical care were satisfied. Conclusions: Largely, MITS appeared to be acceptable for identifying the causes of child deaths and stillbirths, if the parents and family are counseled appropriately considering the sociocultural and religious aspects. They perceived the quality of care, attitude and communication by the healthcare providers as critical factors for acceptance of MITS. Plain language summary: India tops the chart of childhood deaths and stillbirths globally. The causes of many childhood deaths and stillbirths remain unknown or ill-defined in India. For planning the health policies, program and clinical practices, the cause of death (CoD) and stillbirth are primarily determined by verbal autopsy (VA) method, which has several inherent limitations. The acceptance and implementation of complete diagnostic autopsy (CDA) or full autopsy for CoD determination is limited. Minimally invasive tissue sampling (MITS) is a suitable alternative to full autopsy for CoD determination. MITS has been found to be acceptable and being implemented in some low and middle income countries. Considering the multi-religion and sociocultural contexts of India, an understanding about the perceptions, practices, acceptance and barriers among the parents, community members and religious leaders regarding MITS was necessary for designing appropriate communication strategies and materials for consent. A qualitative study was undertaken in New Delhi, India using in-depth interviews with the parents of deceased children and stillbirths, community leaders, community health workers and religious leaders and focus group discussions with the community members and observation of obtaining consent for MITS. The parents and community members were positive about MITS and expressed willingness to accept it over full autopsy to know the CoD and stillbirths. The factors like past stillbirths and child deaths, experience of the healthcare received and trust, the religious and sociocultural norms emerged as important determinants for acceptance of MITS. The religious leaders were also positive about MITS if needed for treatment and benefit of the family. [ABSTRACT FROM AUTHOR]

Background: Parents of dying children face unique challenge and expect compassionate support from health care providers (HCPs). This study explored the experiences of the parents and HCPs about the end-of-life care and breaking bad news and related positive and negative factors in Indian context. Methods: This qualitative exploratory study was conducted at paediatrics department of a tertiary care hospital in Delhi. In-depth interviews with the parents (n = 49) and family members (n = 21) of the children died at the hospital and HCPs (6 doctors, 6 nurses and 4 support staffs) were conducted. Also events and communication around death of eight children were observed. Data were inductively analysed using thematic content analysis method to identify emerging themes and codes. Results: Doctors were the lead communicators. Majority of parents perceived the attitude, communication and language used as by resident doctors as brief, insensitive and sometimes inappropriate or negative. They perceived that the attitude and communication by senior doctor's as empathetic, positive and complete. Parents recalled the death declaration by resident doctors as non-empathetic, blunt and cold. Most parents received no emotional support from HCPs during and after death of their child. All doctors expressed that death of their patients affected them and their emotions, which they coped through different activities. The overcrowded wards, high workload, infrastructural limitation and no formal communication training added to the emotional stress of the HCPs. Conclusions: Majority of the communication by the HCPs during the hospitalisation and end-of-life period were perceived as suboptimal by the parents. The HCPs were emotionally affected and faced end-of-life communication challenges. The study highlights the communication by HCPs and support for parents during the end-of-life communication and breaking bad news. It suggests adoption of context specific communication protocol and materials and training of HCPs in communication to improve the quality of care. Author summary: The parents of terminally ill and dying children face unimaginably psychological stress and have strong need for compassionate professional support. To improve the parents and family experience, there is need for obtaining feedback and documenting the experiences of parents, family and healthcare providers with reference to the local contexts. There is limited information on parents experience on end-of-life communication related to their child death from Indian context. An exploratory qualitative study was conducted at a tertiary care hospital in India involved in-depth interviews with parents and family of deceased children and healthcare providers (HCPs: doctors, nurses and support staffs) involved in treating children. Parents remembered the communication by junior doctors as brief, inappropriate and insensitive, while the senior doctor's communication was positive and complete. The death declaration by resident doctors was remembered as non-empathetic, blunt and cold. No emotional support was received by them around and after child's death. The doctors were affected emotionally with death of the patients, but were constrained with high workload, infrastructural limitations and lack of training in communication. Preparation of context specific, sociocultural appropriate module and communication training for HCPs can improve their competence for providing end-of-life care, breaking bad news and also parents experience. [ABSTRACT FROM AUTHOR]

Background: Around 5.4 million under-five deaths occur globally annually. Over 2.5 million neonatal deaths and an equivalent stillbirths also occur annually worldwide. India is largest contributor to these under-five deaths and stillbirths. To meet the National Health Policy goals aligned with sustainable development targets, adoption of specific strategy and interventions based on exact causes of death and stillbirths are essential. The current cause of death (CoD) labelling process is verbal autopsy based and subject to related limitations. In view of rare diagnostic autopsies, the minimally invasive tissue sampling (MITS) has emerged as a suitable alternate with comparable efficiency to determine CoD. But there is no experience on perception and acceptance for MITS in north Indian context. This formative research is exploring the perceptions and view of families, communities and healthcare providers regarding MITS to determine the acceptability and feasibility. Methods: The cross-sectional study adopts exploratory qualitative research design. The study will be conducted in New Delhi linked to deaths and stillbirths occurring at a tertiary care hospital. The data from multiple stakeholders will be collected through 53–60 key-informant in-depth interviews (IDIs), 8 focus group discussions (FGDs) and 8–10 death or stillbirth event observations. The IDIs will be done with the parents, family members, community representatives, religious priests, burial site representatives and different health care providers. The FGDs will be conducted with the fathers, mothers, and elderly family members in the community. The data collection will focus on death, post-death rituals, religious practices, willingness to know CoD, acceptability of MITS and decision making dynamics. Data will be analysed following free listing, open coding, selective coding and theme identification. Subsequently 8–10 parents will be approached for consent to conduct MITS using the communication package to be developed using the findings. Discussion: The study will provide in-depth understanding of the cultural, social, religious practices related to child death and stillbirth and factors that potentially determine acceptance of MITS. The findings will guide development of communication and counselling package and strategies for obtaining consent for MITS. The pilot experience on obtaining consent for MITS will inform suitable refinement and future practice. [ABSTRACT FROM AUTHOR]

Background: Health research in low- and middle- income countries (LMICs) is often driven by donor priorities rather than by the needs of the countries where the research takes place. This lack of alignment of donor's priorities with local research need may be one of the reasons why countries fail to achieve set goals for population health and nutrition. India has a high burden of morbidity and mortality in women, children and infants. In order to look forward toward the Sustainable Development Goals, the Indian Council of Medical Research (ICMR) and the INCLEN Trust International (INCLEN) employed the Child Health and Nutrition Research Initiative's (CHNRI) research priority setting method for maternal, neonatal, child health and nutrition with the timeline of 2016-2025. The exercise was the largest to-date use of the CHNRI methodology, both in terms of participants and ideas generated and also expanded on the methodology.Methods: CHNRI is a crowdsourcing-based exercise that involves using the collective intelligence of a group of stakeholders, usually researchers, to generate and score research options against a set of criteria. This paper reports on a large umbrella CHNRI that was divided into four theme-specific CHNRIs (maternal, newborn, child health and nutrition). A National Steering Group oversaw the exercise and four theme-specific Research Sub-Committees technically supported finalizing the scoring criteria and refinement of research ideas for the respective thematic areas. The exercise engaged participants from 256 institutions across India - 4003 research ideas were generated from 498 experts which were consolidated into 373 research options (maternal health: 122; newborn health: 56; child health: 101; nutrition: 94); 893 experts scored these against five criteria (answerability, relevance, equity, innovation and out-of-box thinking, investment on research). Relative weights to the criteria were assigned by 79 members from the Larger Reference Group. Given India's diversity, priorities were identified at national and three regional levels: (i) the Empowered Action Group (EAG) and North-Eastern States; (ii) States and Union territories in Northern India (including West Bengal); and (iii) States and Union territories in Southern and Western parts of India.Conclusions: The exercise leveraged the inherent flexibility of the CHNRI method in multiple ways. It expanded on the CHNRI methodology enabling analyses for identification of research priorities at national and regional levels. However, prioritization of research options are only valuable if they are put to use, and we hope that donors will take advantage of this prioritized list of research options. [ABSTRACT FROM AUTHOR]

Background & objective: Genetic factors could play an important role in the outcome of pregnancy. This study was carried out to identify risk factors that result in adverse pregnancy outcome and to develop a system of screening and referral to a tertiary hospital equipped with facilities for diagnosis and management of such high risk pregnancies. Methods: District level hospitals close to the participating centers e.g. All India Institute of Medical Sciences, New Delhi, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, BJ Medical College, Pune, St. John Medical College, Bangalore and Genetic Research Center, (ICMR), Mumbai, were selected. Pregnant women < 28 wk gestation attending antenatal OPD of selected district hospitals were included. All eligible women who gave consent for participation in the study, were screened using a predesigned proforma based on family history; past pregnancy history, history of genetic disease/congenital malformation in previous child and history of present pregnancy. Pregnancy outcome was noted. Results: There was statistically significant difference in the outcome of pregnancy in the following groups: (i) past pregnancy history of 3 or more spontaneous abortions (RR= 3.9; C1=t.17-9.02); (ii) still birth |RR= 2.5; CI= 1.414.48); (iii) previous child with neurol tube detect (NTD) (RR=2.3; C1 = 1.22- 4.60); and (iv) previous child with congenital malformation (RR=2.2; CI = 1.11- 4.35). Interpretation & conclusion: A sample questionnaire may be used for screening of pregnant women at risk of having and adverse outcome. Also screening of pregnant women for thalassaemia carrier state and maternal serum α.-foetoprotein (AFP) for NTD may be useful. [ABSTRACT FROM AUTHOR]

Background: India contributes the highest share of under-five and neonatal deaths and stillbirths globally. Diagnostic autopsy, although useful for cause of death identification, have limited acceptance. Minimally invasive tissue sampling (MITS) is an alternative to autopsy for identification of the cause of death (CoD). A formative research linked to pilot MITS implementation was conducted to document the perceptions and attitudes of the healthcare professionals and the barriers for implementation.Methods: This exploratory qualitative study conducted at a tertiary care hospital in New Delhi, India included the hospital staffs. In-depth interviews were conducted with the doctors, nurses and support staffs from pediatrics, neonatology, obstetrics and forensic medicine departments. Inductive data analysis was done to identify the emerging themes and codes.Results: A total of 26 interviews (doctors, n = 10; nurses, n = 9 and support staffs, n = 7) were conducted. Almost all professional and support staffs were positive about the MITS and its advantage for CoD identification including co-existing and underlying illnesses. Some opined conduct of MITS for the cases without clear diagnosis. All participants perceived that MITS would be acceptable for parents due to the non-disfigurement and preferred by those who had unexplained child deaths or stillbirths in past. The key factors for MITS acceptance were appropriate communication, trust building, involvement of senior doctors, and engagement of the counselor prior to deaths and training of the personnel. For implementation and sustenance of MITS, involvement of the institute authority and government stakeholders would be essential.Conclusions: MITS was acceptable for the doctors, nurses and support staffs and critical for better identification of the causes of death and stillbirths. The key facilitating factors and challenges for implementing MITS at the hospital in Indian context were identified. It emphasized on appropriate skill building, counseling, system organization and buy-in from institution and health authorities for sustenance of MITS. [ABSTRACT FROM AUTHOR]

Background & objectives: Healthcare workers (HCWs) are at an elevated risk of contracting COVID-19. While intense occupational exposure associated with aerosol-generating procedures underlines the necessity of using personal protective equipment (PPE) by HCWs, high-transmission efficiency of the causative agent [severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)] could also lead to infections beyond such settings. Hydroxychloroquine (HCQ), a repurposed antimalarial drug, was empirically recommended as prophylaxis by the National COVID-19 Task Force in India to cover such added risk. Against this background, the current investigation was carried out to identify the factors associated with SARS-CoV-2 infection among HCWs in the country. Methods: A case-control design was adopted and participants were randomly drawn from the countrywide COVID-19 testing data portal maintained by the ICMR. The test results and contact details of HCWs, diagnosed as positive (cases) or negative (controls) for SARS-CoV-2 using real-time reverse transcription-polymerase chain reaction (qRT-PCR), were available from this database. A 20-item brief-questionnaire elicited information on place of work, procedures conducted and use of PPE. Results: Compared to controls, cases were slightly older (34.7 vs. 33.5 yr) and had more males (58 vs. 50%). In multivariate analyses, HCWs performing endotracheal intubation had higher odds of being SARS-CoV-2 infected [adjusted odds ratio (AOR): 4.33, 95%% confidence interval (CI): 1.16- 16.07]. Consumption of four or more maintenance doses of HCQ was associated with a significant decline in the odds of getting infected (AOR: 0.44; 95 CI: 0.22-0.88); a dose-response relationship existed between frequency of exposure to HCQ and such reductions (ϰ2 for trend=48.88; P<0.001). In addition, the use of PPE was independently associated with the reduction in odds of getting infected with SARS-CoV-2 Interpretations & conclusions: Until results of clinical trials for HCQ prophylaxis become available, this study provides actionable information for policymakers to protect HCWs at the forefront of COVID-19 response. The public health message of sustained intake of HCQ prophylaxis as well as appropriate PPE use need to be considered in conjunction with risk homoeostasis operating at individual levels [ABSTRACT FROM AUTHOR]

In India, research prioritization in Maternal, Newborn, and Child Health and Nutrition (MNCHN) themes has traditionally involved only a handful of experts mostly from major cities. The Indian Council of Medical Research (ICMR)-INCLEN collaboration undertook a nationwide exercise engaging faculty from 256 institutions to identify top research priorities in the MNCHN themes for 2016-2025. The Child Health and Nutrition Research Initiative method of priority setting was adapted. The context of the exercise was defined by a National Steering Group (NSG) and guided by four Thematic Research Subcommittees. Research ideas were pooled from 498 experts located in different parts of India, iteratively consolidated into research options, scored by 893 experts against five pre-defined criteria (answerability, relevance, equity, investment and innovation) and weighed by a larger reference group. Ranked lists of priorities were generated for each of the four themes at national and three subnational (regional) levels [Empowered Action Group & North-Eastern States, Southern and Western States, & Northern States (including West Bengal)]. Research priorities differed between regions and from overall national priorities. Delivery domain of research which included implementation research constituted about 70 per cent of the top ten research options under all four themes. The results were endorsed in the NSG meeting. There was unanimity that the research priorities should be considered by different governmental and non-governmental agencies for investment with prioritization on implementation research and issues cutting across themes. [ABSTRACT FROM AUTHOR]

Primary healthcare caters to nearly 70% of the population in India and provides treatment for approximately 80-90% of common conditions. To achieve universal health coverage (UHC), the Indian healthcare system is gearing up by initiating several schemes such as National Health Protection Scheme, Ayushman Bharat, Nutrition Supplementation Schemes, and Inderdhanush Schemes. The healthcare delivery system is facing challenges such as irrational use of medicines, over- and under-diagnosis, high out-of-pocket expenditure, lack of targeted attention to preventive and promotive health services, and poor referral mechanisms. Healthcare providers are unable to keep pace with the volume of growing new scientific evidence and rising healthcare costs as the literature is not published at the same pace. In addition, there is a lack of common standard treatment guidelines, workflows, and reference manuals from the Government of India. Indian Council of Medical Research in collaboration with the National Health Authority, Govt. of India, and the WHO India country office has developed Standard Treatment Workflows (STWs) with the objective to be utilized at various levels of healthcare starting from primary to tertiary level care. A systematic approach was adopted to formulate the STWs. An advisory committee was constituted for planning and oversight of the process. Specialty experts' group for each specialty comprised of clinicians working at government and private medical colleges and hospitals. The expert groups prioritized the topics through extensive literature searches and meeting with different stakeholders. Then, the contents of each STW were finalized in the form of single-pager infographics. These STWs were further reviewed by an editorial committee before publication. Presently, 125 STWs pertaining to 23 specialties have been developed. It needs to be ensured that STWs are implemented effectively at all levels and ensure quality healthcare at an affordable cost as part of UHC., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Grover, Bhargava, Srivastava, Sharma, Cherian, Tandon, Chandershekhar, Ofrin, Bekedam, Pandhi, Mukherjee, Dhaliwal, Singh, Rajshekhar, Roy, Rasaily, Saraf, Kumar, Parmar, Kabra, Chaudhry, Deorari, Tandon, Singh, Khaitan, Agrawala, Gupta, Goel, Bhansali, Dutta, Seth, Singh, Awasthi, Seth, Pandian, Jha, Dwivedi, Tripathi, Thakar, Jindal, Gangadhar, Bajaj, Kant and Chatterjee.)

Dibrugarh Health and Demographic Surveillance System (Dibrugarh-HDSS), was started in the year 2019 with the objective to create the health and demographic database of a population from a defined geographical area and a surveillance system for providing technical assistance for the implementation of programmes and formulating intervention strategies for reducing disease morbidities and mortalities in the population. Dibrugarh-HDSS adopted a panel design and covered 60 contiguous villages and 20 tea gardens. Line listing of all the households was conducted and a unique identification number detailing State, district, village/tea garden and serial number was provided along with geotagging. Detailed sociodemographic variables, anthropometric measurements (subjects ≥five years) and blood pressure data (subjects ≥18 yr), disease morbidity and mortality were collected. All data were collected in pre-designed and pre-tested questionnaires using a mobile application package developed for this purpose. Dibrugarh-HDSS included a total of 106,769 individuals (rural: 46,762, tea garden: 60,007) with 52,934 males (49.6%) and 53,835 females (50.4%). The number of females per thousand males were significantly higher (1042 in tea garden vs. 985 in rural populations) in the tea-garden community as compared to the village population. More than one-third (35.1%) of tea populations were illiterate compared to the rural population (17.1%). Villagers had significantly higher body mass index than the tea-garden community. The overall prevalence of hypertension (adjusted for age) was 29.4 vs. 28.2 per cent, respectively, for the village and tea-garden population. For both these communities, males (village=30.8%, tea garden=31.1%) showed a higher prevalence of hypertension (adjusted for age) than females (village=28.2%, tea garden=25.8%). The findings of the present study give an insight into the profile of the native rural and tea-garden populations that will help to identify risk factors of different health problems, review the effectiveness of different ongoing programmes, implement intervention strategies for reducing morbidity and mortality and assist the State health authorities in prioritizing their resource allocation and implementation strategies.

Low birth weight is associated with morbidities and mortality in the later life. Prevalence of anemia and under nutrition in Assam were reported to be high which may correlate with low birth weight of infants. The present study assessed prevalence and risk factors for low birth weight in a health and demographic cohort established in Dibrugarh district, Assam. A total of 1437 deliveries (580 from rural and 857 from tea garden) were recorded during March 2019 to February 2020. Prevalence of low birth weight was 30.34%. Tea-garden community [OR: 1.4 (1.06-1.79)], low levels of maternal education [OR: 1.57(1.12-2.13)], low monthly income [OR: 2.1 (1.1-3.9)], pre-term birth [OR: 4.1 (2.2-7.9)] and mother with low BMI [OR: 1.6 (1.3-2.07)] were found to be significantly associated with low birth weight. Intervention strategies to improve socioeconomic condition, promote antenatal checkup and alleviate under nutrition in pregnant mothers are warranted to reduce low birth weight., (© 2022. Dr. K C Chaudhuri Foundation.)

Objective: To observe and compare breastfeeding practices in villages and tea-gardens., Methods: Analytical cross-sectional study among mothers of infants in a health and demographic surveillance site in Dibrugarh, Assam., Results: 1435 mothers (855 from tea-gardens, 580 from villages); and 1437 infants (857 from tea-gardens, 580 from villages), were included in study. Mean maternal age was 25.1 (4.4) years in tea-gardens and 25.8 (4.9) years in villages. Timely initiation of breastfeeding was higher in villages (82.6%) than tea-gardens (76.4%). Feeding colostrum was higher in villages (71.2%) than tea-gardens (60.8%)., Discussion: Factors affecting breastfeeding were different in villages and tea-gardens. Timely initiation of breastfeeding was associated with nuclear family in villages and joint family in tea-gardens. Hence, interventions promoting breastfeeding practices should be tailored instead of one-size-fits-all approach.

Background: Progress has been made in the reduction of under-five mortality in India; however, neonatal mortality is reducing at a slower rate. Efforts are required to bring down neonatal mortality in order to attain the Sustainable Development Goal-3. Prevention of sepsis among the high-risk, vulnerable low birth weight neonates by a newer intervention with probiotic supplementation is promising., Methods: A phase III, multicenter, randomized, double-blind, placebo-controlled study is being conducted at six sites in India. A total of 6144 healthy low birth weight (LBW) infants fulfilling the eligibility criteria would be enrolled within the first week of life, after obtaining written informed consent from the parents of the infant. Randomization in 1:1 ratio, stratified by site, sex, and birth weight, would be done through an interactive web response system (IWRS) using a standard web browser and email service. Vivomixx®, a probiotic containing a mix of 8 strains of bacteria, in a suspension form standardized to deliver 10 billion CFU/ml, or an organoleptically similar placebo would be fed to enrolled infants in a 1-ml/day dose for 30 days. The follow-up of enrolled infants for 60 days would take place as per a pre-specified schedule for recording morbidities and outcome assessments at the six participating sites. Screening for morbidities would be conducted by trained field workers in the community, and sick infants would be referred to designated clinics/hospitals. A physician would examine the referred infants presenting with complaints and clinical signs, and blood samples would be collected from sick infants for diagnosis of neonatal sepsis by performing sepsis screen and blood culture. Appropriate treatment would be provided as per hospital protocol. The study would be implemented as per the MRC guideline for the management of Global Health Trials in accordance with ICH-GCP and Indian Regulatory guidelines. A contract research organization would be engaged for comprehensive monitoring and quality assurance. The final analysis would be conducted in a blinded manner as per the statistical analysis plan (SAP) to estimate the primary outcomes of sepsis, possible serious bacterial infection (PSBI), and secondary outcomes. The codes will be broken after DMC permission. The protocol has been reviewed by the Research Ethics Committee of the Liverpool School of Tropical Medicine (REC-LSTM), from Research Ethics Committees of the six subject recruitment participating sites., Discussion: This adequately powered and well-designed trial would conclusively answer the question whether probiotics can prevent neonatal sepsis in the high-risk group of low birth weight infants as indicated by a pilot study in 1340 LBW infants, evidence from systematic reviews of hospital-based studies, and a primary study on healthy newborns in Orissa. Results of the study would be generalizable to India and other low-middle-income countries., Trial Registration: Clinical Trial Registry of India (CTRI) CTRI/2019/05/019197 . Registered on 16 May 2019.

Background: Grief following stillbirth and child death are one of the most traumatic experience for parents with psychosomatic, social and economic impacts. The grief profile, severity and its impacts in Indian context are not well documented. This study documented the grief and coping experiences of the Indian parents following stillbirth and child death., Methods: This exploratory qualitative study in Delhi (India) included in-depth interviews with parents (50 mothers and 49 fathers), who had stillbirth or child death, their family members (n = 41) and community representatives (n = 12). Eight focus group discussions were done with community members (n = 72). Inductive data analysis included thematic content analysis. Perinatal Grief Scale was used to document the mother's grief severity after 6-9 months of loss., Results: The four themes emerged were grief anticipation and expression, impact of the bereavement, coping mechanism, and sociocultural norms and practices. The parents suffered from disbelief, severe pain and helplessness. Mothers expressed severe grief openly and some fainted. Fathers also had severe grief, but didn't express openly. Some parents shared self-guilt and blamed the hospital/healthcare providers, themselves or family. Majority had no/positive change in couple relationship, but few faced marital disharmony. Majority experienced sleep, eating and psychological disturbances for several weeks. Mothers coped through engaging in household work, caring other child(ren) and spiritual activities. Fathers coped through avoiding discussion and work and professional engagement. Fathers resumed work after 5-20 days and mothers took 2-6 weeks to resume household chores. Unanticipated loss, limited family support and financial strain affected the severity and duration of grief. 57.5% of all mothers and 80% mothers with stillbirth had severe grief after 6-9 months., Conclusions: Stillbirth and child death have lasting psychosomatic, social and economic impacts on parents, which are usually ignored. Sociocultural and religion appropriate bereavement support for the parents are needed to reduce the impacts., Competing Interests: The authors have declared that no competing interests exist.

Background: Home-based newborn care has been found to reduce neonatal mortality in rural areas. Study evaluated effectiveness of home-based care delivered by specially recruited newborn care workers- Shishu Rakshak (SR) and existing workers- anganwadi workers (AWW) in reducing neonatal and infant mortality rates., Methods: This three-arm, community-based, cluster randomised trial was conducted in five districts in India. Intervention package consisted of pregnancy surveillance, health education, care at birth, care of normal/low birthweight neonates, identification and treatment of sick neonates and young infants using oral and injectable antibiotics and community mobilisation. The package was similar in both intervention arms-SR and AWW; difference being healthcare provider. The control arm received routine health services from the existing health system. Primary outcomes were neonatal and young infant mortality rates at 'endline' period (2008-2009) assessed by an independent team from January to April 2010 in the study clusters., Findings: A total of 6623, 6852 and 5898 births occurred in the SR, AWW and control arms, respectively, during the endline period; the proportion of facility births were 69.0%, 64.4% and 70.6% in the three arms. Baseline mortality rates were comparable in three arms. During the endline period, the risk of neonatal mortality was 25% lower in the SR arm (adjusted OR 0.75, 95% CI 0.57 to 0.99); the risks of early neonatal mortality, young infant mortality and infant mortality were also lower by 32%, 27%, and 33%, respectively. The risks of neonatal, early neonatal, young infant, infant mortality in the AWW arm were not different from that of the control arm., Interpretation: Home-based care is effective in reducing neonatal and infant mortality rates, when delivered by a dedicated worker, even in settings with high rates of facility births., Trial Registration Number: The study was registered with Clinical Trial Registry of India (CTRI/2011/12/002181)., Competing Interests: Competing interests: None declared, (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: There is a paucity of data on the epidemiology of sepsis in outborn neonates being referred to level-3 units in low- and middle-income countries (LMIC). The objective of the present study was to evaluate the prevalence of sepsis and outcomes of outborn neonates with sepsis, and to characterize the pathogen profile and antimicrobial resistance (AMR) patterns of common isolates in them., Methods: In this prospective observational cohort study (2011-2015), a dedicated research team enrolled all neonates admitted to an outborn level-3 neonatal unit and followed them until discharge/death. Sepsis work-up including blood culture(s) was performed upon suspicion of sepsis. All the isolates were identified and tested for antimicrobial susceptibility. Gram-negative pathogens resistant to any three of the five antibiotic classes (extended-spectrum cephalosporins, carbapenems, aminoglycosides, fluoroquinolones, and piperacillin-tazobactam) were labeled multi-drug resistant., Results: Of the total of 2588 neonates enrolled, culture positive sepsis and total sepsis-i.e. culture positive and/or culture negative sepsis-was diagnosed in 13.1% (95% CI 11.8% to 14.5%) and 54.7% (95% CI 52.8% to 56.6%), respectively. The case fatality rates were 23.4% and 11.0% in culture-positive and total sepsis, respectively. Sepsis accounted for two-thirds of total neonatal deaths (153/235, 63.0%). Bacterial isolates caused about three-fourths (296/401; 73.8%) of the infections. The two common pathogens-Klebsiella pneumoniae (n = 50, 12.5%) and Acinetobacter baumannii (n = 46, 11.5%)-showed high degree of multi-drug resistance (78.0% and 91.3%, respectively) and carbapenem resistance (84.0% and 91.3%, respectively). About a quarter of infections were caused by Candida spp. (n = 91; 22.7%); almost three-fourths (73.7%) of these infections occurred in neonates born at or after 32 weeks' gestation and about two-thirds (62.1%) in those weighing 1500 g or more at birth., Conclusions: In this large outborn cohort, we report high burden of sepsis, high prevalence of systemic fungal infections, and alarming rates of antimicrobial resistance among bacterial pathogens., Competing Interests: The authors have declared that no competing interests exist.