Saumya Test file 2 text 1suppl
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| Title [1] | Saumya Test file 2 text 1suppl | ||
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| Author(s) | Saumya Dwivedi | ||
| Platform | Bharatiya Jnana Sarita | ||
| Categories | Vedic Philosophical and Cognitive Science | ||
| Year | 2026 | ||
| Type of Article | Original Article - Short Form | ||
| Difficulty Level | Advance | ||
| Abstract | I have added 2 main text file (one text and one image) and one additional png supplementary file. | ||
Strengthening Near-to- Home Management of Possible Serious Bacterial Infection (PSBI) in Sick Young Infants (0-59 Days) When Referral is Not Feasible: An Implementation Research Study in a Rural Block of Kanpur District, Uttar Pradesh (India)
Introduction:
Globally, 2.3 million newborn lives ended in the first month of life, accounting for almost half of the under-five deaths (ref, ref ). Despite a considerable decline in under-5 mortality (ref), the reduction of neonatal mortality remains sluggish posing a challenge to the LMIC’s target of achieving the SDG goal (3.2) of “ending preventable deaths of newborns by 2030, with all countries aiming to reduce neonatal mortality below 12 per 1000 live births”. (ref, ref?). Amidst the largest number of neonatal deaths (39%) occurring in Southern Asia, India stands to be one in the five countries that account for half of all newborn deaths (UNICEF, 2017 (2)(ref, ref).
Sepsis & infections contribute to 35% of neonatal deaths in South Asia, making it the second major contributing cause of neonatal mortality after prematurity (ref, ref, ref). The recommended management for sepsis and infection is inpatient treatment, however, in resource-constrained settings, accessing specialized care in higher facilities and longer hospital admission remains challenging (Ref). Large field trials from Africa and Asia demonstrated the efficacy of simplified antibiotic treatment for young infants with sepsis, and infections, broadly grouped under the syndromic category of Possible Serious Bacterial Infection or PSBI, in an outpatient setting. Building on the evidence, World Health Organization (WHO), in 2015, recommended that PSBI should be managed with a 7 days simplified antibiotic regimen (ref, ref, ref) on an outpatient basis when referral to higher facilities is not feasible (ref, ref, ref, ref, ref, ref). This further contextualized in broader Integrated Management of Newborn and Child Illness or IMNCI guideline that provides a tool for non- specialists to systematically classify , identify treatment and manage various morbidities amongst children upto 5 years of age.
In 2014, an operational guidelines empowered Auxiliary Nurse Midwives (ANMs) to use injectable gentamicin along with oral antibiotics for management of sepsis in young infants when referral is not feasible was released (ref). A subsequent addendum was published in 2017 that included all primary care workers ( Medical Officers, ANMs, Staff Nurse and Community Health Officers) , reduced a couple of danger signs and changed gentamicin dose strength to harmonize with global WHO recommendation (Ref). However, despite the formulation of the WHO protocol and operational guidelines to establish IMNCI as a central strategy to improve newborn outcomes, the grassroot implementation of IMNCI could not be successful even in the initial years of formulation and scale-up. (ref, ref).
PSBI management guideline was integrated conceptually with others related programmes, like Home Based Newborn Care , Janani Shishu Suraksha Karyakram (JSSK) (ref), IMNCI (Integrated Management of Newborn & Childhood Illness) & most recently SAANS (Social Awareness and Actions to Neutralize Pneumonia Successfully) for treatment management (ref). But at the system level, program-specific mandates continue to be implemented in a fragmented manner, rather than a comprehensive, case-based care continuum resulting in poor outcomes due to truncated care pathways. Thus, contributing to poor identification coverage (ref), lack of community awareness, delay in formalized care seeking, collectively resulting in underutilisation of services or fragmented care and plurality of treatment. Previous studies across south Asia established the feasibility of implementing the simplified antibiotic regimen at the primary healthcare facilities for the treatment of PSBI (ref, ref, ref). However, for most of these studies, the primary focus area remained operationalizing facilities to successfully manage infants who reached the facility. Moreover, the strategies around strengthening the communities for identification and care seeking and adherence to treatment remained blur. Our study aimed at developing a scalable mother-infant centric model to improve the coverage of PSBI identification and its recommended treatment in young infants of age 0-59 days with PSBI. It demonstrated a multipronged grounds-up approach of concurrently building the demand and supply of newborn healthcare services through (1) improving community recognition of danger signs and promoting appropriate and timely care-seeking in community and (2) Operationalization of primary healthcare facilities for PSBI case management.
Methodology:
Study Site & Study Setting:
The study was conducted in Shivrajpur block in Kanpur Nagar, Uttar Pradesh, India, situated approximately 35 Kms (26°51′26″N 79°06′54″E) from the heart of Kanpur city.
xx. This rural block has a total of 36 public health facilities, including one Community Health Center, 4 Primary Health Centers and 29 Ayushman Aarogya Mandirs that cater to a population of 1,33,839, with 52.7% (70485) males and 47.3% (63354) females, and a crude birth rate of 19.5. Based on three years of retrospective data collection, the stillbirth rate was found to be 3.10% against the xx(Ref). 77% of the births are institutional. In context to public health service delivery, even though the Ayushman Arogya Mandir are evenly distributed, covering a population size of ~5000, these facilities were under establishment phase and remained under-resourced. PHC’s on the other hand remained largely under-prioritized. The CHC, served as key nodal facility in the referral chain within the block, but this facility also is constrained in providing intermittent paediatric services for only limited days and hours, subject to the availability of paediatrician. As can be seen in the map (Figure 1), the area is fairly dotted with unqualified medical practitioners, underscoring the dominance of informal care networks. The population therefore relied on either the 2 private facilities located within the block or the multiple private practitioners in nearby peri-urban. The nearest tertiary care facility is the government medical college located 37 Kms from the block .
Study Design
This implementation study was designed to develop a mother infant centric model to identify and manage sick young infant with PSBI. The study spanned across a period of 23 months from May 2023 to March 2025 with three major phases:a. Formative phase, b. Model Conceptualization phase and c. Model Implementation and refinement phase. The a mixed methods approach was adapted to capture implementation learning, triangulating qualitative and quantitative data which rapidly informed refinement strategies in multiple iterative cycles for understanding, co-designing & model crystallization. Implementation research principles were utilised to map various barriers and facilitators according to the Design Outcome cascade Framework (Ref). The framework included both, the top down and bottom up approach for the outcome analysis and design thinking respectively. The Imeplemtation support team engaged with stakeholders and beneficiaries to understand the context and inform the model from the ground level. Block health system led various strategies and implementation of interventions and PSBI management guideline. The research team monitored the processes and impact of the implementation strategy. We evaluated the effective coverage, process outcomes and key performance indicators during each iterative cycle. Although the model targeted sick young infants with PSBI, from a user centric design perspective, the scope of the model was expanded to support mothers of infants with any sickness within the stipulated age group.
Formative Phase:
The study began with an initial round of sensing and mapping of the study site, resources and stakeholders. This phase focused on understanding the home care practices around young infant and elucidating a care pathway of the infant if found to be sick. The study team tracked all the service providers within the area including government facilities, private practitioners as well as Unqualified Medical Practitioners where the families were seeking care for sick young infants. This was accomplished through in-depth qualitative assessments, including in depth interviews, focused group discussions and observations at home and in the facility. The stakeholder context mapping was conducted according to the Knowledge, Skill, Motivation & Enabling Environment (KSME) Framework (Ref) for stakeholders across the service delivery pathway including, ASHA, ASHA Sangini, ANM, CHO, Block management unit, pharmacists, ambulance manager among few. During the later part of the study also, qualitative assessments were conducted which are detailed in Table 1
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Table 1: Qualitative assessments conducted during the formative and implementation phase of the study.
| S. No | Participants | Purpose | Method | Timeline | Sample Size |
| 1 | Mothers and caregivers
who have reported any illness in the first 60 days of life |
Journey mapping of sick young infants with identification, care seeking and treatment as key milestones. | In depth interview | ||
| 2 | Mothers and caregivers of
Young infants, both sick and healthy |
Understanding acceptance of model
strategies and utilization of key services by caregivers, and taking suggestions on model/ service improvement |
Focus Group Discussions (FGDs) | ||
| 3 | Young infants with PSBI being cared for at home/ post discharge | Documenting care practices at home, including routine practices, caregiver involvement, decision making, use of medication, challenges, etc. | Non-participant
observation at home. |
||
| 4. | Young infants with PSBI being
cared at a primary healthcare facility. |
Understanding the care of sick young infants at primary hospitals, Including processes of outpatient consultation, emergency care, admission, discharge, treatment, record-keeping, supplies, etc. | Non-participant
Observation at the facility. |
||
| 5. | ASHA workers,ASHA Supervisors (referred as Sanginis) | Understanding the existing role, knowledge, Skills, motivation and
Enabling environment for Community health workers who may potentially play a role in PSBI identification, community referrals and follow-up. |
1. Field observations:
2. In-depth interviews (IDIs) 3. Focus Group Discussions (FGDs) |
||
| 6. | Front line care providers: Staff nurses, ANM, Community Health Officer (CHO), Pharmacists, trained and Unqualified medical
Practitioners. |
Understanding the existing role, knowledge, Skills, motivation and
Enabling environment of service providers (both public & private) who may potentially play a role in community based PSBI management and assessing |
1. Field observations:
2. In-depth interviews 3. Focus Group Discussions |
||
| 7. | Program Managers & implementers, Facility-In- Charges, at block, district & state levels;
Political representatives at village, block and higher levels; Leaders of professional medical and Nursing associations & experts. |
Understanding the policy and implementation climate, implementation,
information and management needs and challenges of the health system, prospective participation in co-designing & improving PSBI management. |
1. In-depth interviews
from each management/ leadership. 2. Brainstorming/ codesign workshops |
||
| 8. | Facility observation during case assessment & management | Conducted to understand the adherence and quality of implementation of IMNCI protocol. | Observation form |
Model Development
Inception of model blueprint: A Human Centric Design (HCD) (ref), was the underlying approach for developing a model blueprint. The primary focus of the model was to design solutions contouring around the user needs and address end-to-end care delivery for sick young infants. A set of 5 broad themes were mapped for strategizing towards building a seamless care continuum based on the learnings from baseline & formative work. This was done during a co-design workshop with paediatricians and experts who convened every 6 months for consultation on model iterations.
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Iterative Implementation Phase:
The co-design phase dynamically fused into the model refinement phase. This phase saw a gradual transition in the health system context where outpatient management at primary healthcare facilities was established by February 2023 onwards which had significant impact on the referrals and pathway for management of sick YI that now moved. To document the programmatic outcomes, a Design Outcome Cascade framework was utilized. This is a pragmatic multipronged approach where implementers design solutions starting from end user at the bottom of the cascade moving up the hierarchy while the outcomes are measured top to bottom, going from system, to program, provider and subsequently the end user. This cascade involves both top-down and bottom-up approach with a cascade flow across various levels of the system hierarchy. This approach gave opportunity to have rapid reiterations at multiple levels to overcome any implementation barriers and bottlenecks giving multiple opportunities to revise various implementations strategies.
Implementation strategies
- Helpline for identification & coordination
The aforementioned pathway of establishing a helpline for identification of birth and illness, case mobilization and coordination was a key strategy to strengthen & build the demand side of the implementation process ensuring the sick newborns reach public health facilities to seek care. Additionally, this strategy targeted at empowering each and every stakeholder with necessary support to leverage their role in newborn care.
- Tool for mother to seek immediate care and advice for her newborn, and build her awareness and knowledge.
- A quick solution for ASHA to notify and document birth related information within 24 hours of birth, and reinforcing danger sign counselling tomothers.
- Sangini can track & review performance of ASHAs she supervises.
- CHO in identifying sickness cases within the catchment area of their AAM/HWC.
- MOIC & BPMU can track overall data indicators around birth and sickness along with FHW performance.
Thereby, this system ensured the end-to-end coordination shifting the paradigm to individualised care for every newborn.
2. Co-designing Pathway of SYI care: Given the newborn healthcare context during the early study phase, there was a felt need for active intervention to facilitate sickness identification, one-on-one counselling to facilitate care seeking to formal healthcare facilities, and coordination between provider at facility and caregivers to ensure timely services at healthcare facilities. During the initial co-design workshop with community stakeholders primarily including ASHA & mothers, a concept of centralised helpline for birth and sickness notification emerged. In subsequent co-design workshops with community leaders, experts and program implementers, the role of this centralized helpline was redefined to incorporate care coordination which was a major missing piece that was essential to ensure no newborn slips through the existing care gaps. Thus, a centralized care coordination system was conceived, which was better known as ‘SakshaMa’ helpline by mothers and ASHA’s in the community. This system not only handheld families, but it also served as an overarching mechanism that tracked service delivery at every milestone across the care journey thereby helping the leadership and implementers in tracking real time data, progress and performance. The later part of the co-design phase was focussed on establishing the “CCCS pathway for YI care” that has been described in figure (x) along with the following detailed steps:
Figure x: Establishing the pathway of newborn care through central care coordination system
2.1. Birth notification: Early birth identification was the most fundamental need in order to identify any potential sickness in the most vulnerable period of the first day and first week of birth for the infant. To obtain real-time information on births occurring within the catchment area, a potential pathway was co-designed at block level & tested in the catchment area of 2 Sangini. The ASHA & Sangini were provided with birth reporting format & birth register respectively. They were also given a card with a helpline number to which birth reporting could be reported via a call. Upon the success of this pilot, the process was launched and inaugurated by leadership at block.
2.2 Illness Identification: HBNC is the primary source for sickness identification, however, given the context of poor frequency & quality of HBNC (Ref), an alternative supportive strategy was adopted to empower ASHA’s and more importantly the mothers for improving community identification of danger signs. This was done by emphasizing on repeated Counselling & Practice to ensure skill transfer in conducting daily assessments by mother while caring for her baby.
Pathway involved giving helpline card to caregivers by Staff nurses at the time of birth with a detailed counselling session that utilized counselling IEC, danger sign videos & practice for each of the seven danger signs. Mothers were asked to report to the helpline in case they identify any of these signs. Also, this counselling was reinforced in two ways post discharge, one through the HBNC visitation and second through virtual counselling that was conducted once the ASHA reported births to the helpline that registered these births in the database for delivery of the intervention. These calls were of two types: Inbound calls where the mother on the basis of counselling actively reported sickness to the helpline. Other being the outbound calls (helpline->families) were interspersed across the first 60 days of life, with one-on-one counselling call that are made on days 4, 7, 11, and 17 after birth. These calls virtually assesses the young infant (YI) for any illness and reinforces understanding and recognition of danger signs.To optimize process, the call of the later time points were replaced by IVR (Interactive Voice Response) calls that are made on days 22, 29, 36, 43, 50, and 57 after birth. If a mother reports an illness during an IVR call, the helpline follows up with a one on one call to the family to assess the infant virtually. Therefore, the helpline equipped the mother with a 24 x 7 support for guidance on newborn care and sickness reporting.
2.3. Virtual screening & Illness Algorithm: An illness algorithm was co-designed with a panel of paediatricians to screen illnesses reported over mobile phones. This screening was based on the chief complaint by the mother and each chief complaint was recorded by the remote guide assistant (RGA, based on the reported symptoms, a set of leading questions were asked to the mother/caregiver to prepare a first level case sheet documenting chief complaint and danger signs reported if any. Once a case sheet is prepared, it is shared with a virtual panel of paediatricians who virtually assess and review it to give feedback to the RGA and triage the case redirecting it to the nearest and appropriate facility. This step involving the virtual panel was later removed during reiterations as it increased coordination time & could be replaced by the health system once the providers were trained.
2.4 Assessment: These illnesses that were identified in the community were flagged across the block FHWs hierarchy through telephone call (for ASHA) & Whatsapp Group (for CHO & BPMU). The case sheet along with accountable CHO were notified on this group for accountability. Also, if CHO was unavailable or unresponsive, the family was redirected to CHC for assessment. If the infant was found to be critical they were immediately mobilised for CHC and family was supported to avail ambulance service through involvement of ASHA.
2.5 Treatment: The helpline ensures the family reaches the facility that can conduct proper assessment and administer treatment. In the initial phase of the study the helpline primarily facilitated care coordination to tertiary facilities for critical cases and cases with PSBI, whereas in the later part IMNCI protocolised primary healthcare was improved through various implementation strategies which enabled treatment within the block, referring only to CI cases.
2.6 Follow-Up: For supervision of home-based care & outpatient management, the helpline ensures one follow-up call to every SYI every alternate day till the baby recovers. These follow-ups include nudging the family for proper adherence to prescribed medication and follow up visitations.
3. Skill Strengthening & Confidence building
3.1 Recognition & Identification of Danger Sign: The awareness of ASHA on danger signs was an essential prerequisite to strengthen community based recognition of illness. This was not only limited to ASHA’s own illness recognition skills, but her overall ability to transfer this skill to the mothers. In order to build sustainable and scalable solutions around this domain, the role of Sangini’s (ASHA supervisor) was leveraged from supervision to establishing a dynamic team leadership (ref, ref). Implementation support team conducted periodic training and mentoring sessions during the early model development period and started setting up the stage for ASHA Sangini to take complete responsibility of training their respective teams through audio visual materials, IEC and interactions during cluster meetings. These meetings also gave opportunity to assess data driven performance review through dashboards that gave a glimpse to the progress of ASHA’s on birth reporting, individual case journeys and their successes and failures, this service delivery oriented format changed the outlook towards cluster meetings from a report compiling and fund disbursing exercise to a real time experiential learning process that provided encouragement and learning opportunities for these frontline teams.
3.2 Protocolised assessment & management of PSBI: Simplification of IMNCI protocols for its adaptation into scalable solutions was done keeping in mind the needs of non pediatric medical officers (MOs) & Community health officers (CHOs) who found recalling assessment steps and calculating pediatric doses to be increasingly difficult. They were hesitant in handling these pediatric cases and saw them beyond their existing scope of work. Therefore, besides orientation on scope of work and existing guidelines, the team had the challenge for designing solutions that could serve as a guiding process. Multiple solutions were co-designed and implemented and refined such that they could be useful in different contexts and settings. Initial solution that was quickly implemented was designing of a rubber stamp with vitals of the infants and list of 7 danger signs, this was stamped on the OPD slip and served as a quick and sustainable method for documenting the symptomatic details alongwith disease classification on the OPD slip. The other solution developed is a sophisticated digital application to guide assessment and assist in decision making around treatment identification. Existing implementation solutions around IMNCI were modified and simplified based on user needs with emphasis on action steps: job aid guiding subclassification, treatment identification and dosage calculation was developed and provided to implementers, this served as a reference guide for above three major steps of the IMNCI based management process. Additionally, a concise and modified treatment card was implemented for documenting daily antibiotic administration along with patient consent for outpatient management in case of referral refusal. These solutions not only improved assessment and management but also ensured documentation serving the dual purpose of tracking monitoring as well as safeguarding rights of the care providers, thereby improving acceptability of the solutions. The materials are attached in the supplementary section.
3.3 Post training confidence building & hand holding:
Training of medical officers and CHO on the IMNCI package has been implemented across various sites in the previous studies. The current work also relied on the WHO package but abridged the package based on need of the end users including medical officers and Community health Workers by shifting the focus of the package from theoretical case studies to practical exposure of cases in wards at medical college. However, it was found that the training package, though necessary, seemed insufficient to address the implementation gaps at the community level. The non MBBS medical officers and the CHO despite training were still hesitant in administering treatment especially injectables, they needed additional handholding to confidently & successfully manage infants who were to be managed as outpatients in cases of refusal to referral or in cases where pre referral dose was to be administered. The confidence building cycle began by testing a co-designed solution of setting up a rotational duty roster for the community health officers at CHC under the apprenticeship of medical officers. They were supported by IS team for the initial cases along with additional guidance by pediatric medical officers in cases where they needed suggestions. The support was required until they assessed 10-15 cases and managed 2-3 cases administering the 7 day regimen successfully after which most care providers developed the confidence in handling cases independently under remote guidance of medical officers.
4. Facility Operationalization:
To build the supply side of the implementation process, the operationalisation of primary health facilities for effective assessment, outpatient management & referral pathway was a must. The research team co-designed processes that were in line with the recent policy scenario, SAANS guideline, local context and the comprehensive primary healthcare (CPHC) program that include Ayushman Bharat Ayushman Arogya Mandir (AB-AAM) initiative. The model development therefore accelerated the pace of implementation of the AB-HWC initiative and started leveraging the role of Community Health Officers as a prospective cadre for community based management. Although, the Health & Wellness Centre establishment was under process, it experienced hiccups at each step. Despite several efforts, e-Sanjeevani could not be strengthened and posed a major bottleneck owing to availability of doctors and connectivity related challenges. This was overcome by building capacity and functionality at CHC’s & PHC, and establishing leadership of MO for owning the HWC in their respective catchment area. The MO provided the tele-consultation through the mobile network and supported CHO in treatment identification in accordance to the IMNCI protocol..
Facility functionalization also involved bridging other typical implementation gaps such as establishing smooth process for indentation of consumables for which community health officers and MO had joint meetings with leadership on process orientation. Availability of equipments was also ensured during similar discussions through utilisation of untied funds allotted for each AB-AAM and PHC or CHC. In addition to all the above processes that have been described in previous literature, this study additionally focussed on team based approach to strengthening the outreach of HWC. This team included the three frontline health worker cadres: the ASHA, Anganwadi & the ANM. This also provided the necessary support and grounding of CHO who were fresh graduates from urban areas to “settle in” and function within the community setting. With all resources in place and the necessary exposure in handling 10-15 cases, the CHO gained confidence in treatment & management of YI in community setting and referring patients only if required.
Another important component that was crucial in sustaining and progressing the operationalisation was the strengthening of documentation and reporting. This was approached not just from the perspective of record keeping, but also from the perspective of safeguarding the rights of the care provider as a value proposition for accomplishing the tasks of proper documentation. The major points were, maintenance of register with basic records for young infants, treatment card with patient consent and OPD slip documenting vitals and danger signs symptoms presented in young infants.
5. Establishing system accountability & leadership for sustainability
A very helpful tool in creating motivation for reporting and increasing the active engagement of the frontline health workers was to co-design and implement the performance dashboards. While the existing system struggled with keeping track of the primary data itself, this evolved process not only gave the real-time data tracking mechanism but also provided a consolidated dashboard for periodic performance reviews of each cadre. These performance reviews gradually transformed the approach of the system from being instructional and punishment-based to self-reflective and socially rewarding, thereby creating a more respectful and encouraging working environment that nurtured innate leadership skills. Other forms of strategies to fill in the system-level gaps included the Orientation of medical officers on IMNCI protocol and setting accountability for treatment, management and supportive supervision of CHO in the management of young infants along with the administration of injectables. A cascade training approach was utilized to save time and resources and achieve a scalable model. Subsequently, the skill building at the block level was achieved by utilizing the additional expenses through an innovative interconnected team-based approach. Each of the teams and their performance was supported and enhanced by supervision and handholding at the facility level on an individual case basis through a direct facility-based feedback system. A process of documentation, record keeping and live reporting & updating at the block level was also established through a series of small changes in the documentation process that made the record-keeping and implementation of the IMNCI treatment card possible. These strategies were implemented under the canopy of the district co-designing team that comprised the CMO, ACMO, DCPM & the program learning team.
Evaluation Data Collection & Analysis:
The research data was collected by a team of qualitative researchers and quantitative data collectors. The quantitative data collection team consisted of field workers who visited families and primary healthcare facilities, as well as Remote Guide Assistants (RGAs) in CCCS who gathered information from families and community health workers telephonically. Additionally, a separate facility monitoring team was responsible for collecting both quantitative and qualitative data from healthcare facilities.
During the formative phase of the study, qualitative researchers engaged with block and district health system leadership, supply chain managers, ambulance managers, and community healthcare providers including ASHAs, Sanginis, staff nurses, Community Health Officers (CHOs), and both pediatric and non-pediatric Medical Officers. They also interacted with mothers and caregivers of newborns, as well as community influencers such as Gram Pradhan’s, political leaders, and local youth, to understand the existing health system context and to develop the initial version of the model (M0).
Quantitative data was collected by field data collectors and RGAs of CCCS. Field data collectors conducted multiple home visits within the first 60 days of an infant’s life, including scheduled follow-up visits on Days 15, 30, 45, and 60, visits when family reported illnesses in young infants, and on Day 8 after treatment initiation to determine treatment outcome. Data collection was conducted using the digital platform CommCare. The field team received training on CommCare usage, identification of PSBI signs in young infants, and standardization sessions every six weeks by IMNCI-trained personnel.
RGAs telephonically collected and recorded birth information from ASHAs, scheduled follow-up data (on Days 4, 7, 11, and 17), and sickness-related data using the Zoho Creator.
All quantitative data was securely stored on CommCare and Zoho Creator. The collected data was subsequently downloaded from storage servers, and descriptive analysis was conducted using MS Excel to calculate proportions and frequencies.
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Ethical Considerations: The study was approved by the Institutional Ethics Committee of CEL and the WHO-ERC. Written informed consent was obtained from families/mothers at the time of birth registration, explaining the relevance, purpose & scope of work. The participants were informed that participation and agreement/disagreement for participation in the study would result in no direct physical benefit or harm. All the participants were informed of their right to withdraw from the study at any point in time. Each baby was assigned a unique mother-baby ID, and all personal information was securely stored on a safe data server using standard data security and encryption practices for accepting, transmitting, processing, and storing data.
Results:
Birth and Illness identification coverage:
Over the 23-month study period (May 2023–March 2025), a total of 4,280 (93%) live births were recorded in the study area, compared to an expected 4,599 births estimated from a three-year retrospective survey. Across this, period, a total of 2,565 sickness episodes were recorded. More than half of these (1,602/2,565; 62.4%) were notified to the Centralized Care Coordination System (CCC). Mothers and family members were the main identifiers of illness in the community, accounting for 53% and 29% of the cases, respectively.
Table: Programmatic coverage across the study
| Implementation cycle | Cycle 1 | Cycle 2 | Cycle 3 | Cycle 4 | Cycle 5 | Cycle 6 | Total |
| Time period | May 23 to
Aug 23 |
Sep 23 to
Dec 23 |
Jan 24 to
Apr 24 |
May 24 to
Aug 24 |
Sep 24 to
Dec 24 |
Jan 25 to
Mar 25 |
2 May 23 to
31 Mar 25 (23 months) |
| Total no. of live births | 907 | 929 | 686 | 766 | 823 | 169 | 4280 |
| Births captured by CCCS | 801(88.3) | 759(81.7) | 511(74.5) | 545(71.1) | 702(85.3) | 133(78.7) | 3451(80.6) |
| Total no of sickness episodes | 440 | 485 | 456 | 466 | 526 | 97 | 2470 |
| No of sickness captured by CCCS | 296(67.3) | 291(60.0) | 256(56.1) | 293(62.9) | 316(60.1) | 67(69.1) | 1519(61.5) |
| Sickness reported in inbound calls | 166(56.1) | 148(50.9) | 91(35.5) | 89(30.4) | 64(20.3) | 20(29.9) | 578(38.1) |
Awareness of Newborn Danger Signs
On day 30 post-delivery, 76% of mothers were aware of at least one newborn danger sign—an improvement from 66% in the initial phase. High fever remained the most recognized sign (>97% across all cycles). Awareness of breathing difficulty and feeding problems increased over time, with breathing difficulty rising from 40.6% in Cycle 1 to over 70% in Cycle 6, and feeding difficulty from 62.6% to 67.2%. In contrast, awareness of low body temperature fluctuated (35–57%), while lethargy and seizures remained the least recognized (<32%). Notably, seizure awareness rose slightly from 3.9% to 13.4% by Cycle 6.
Identification of PSBI Cases
During the implementation phase of the study (April 2024 to March 2025), a total of 126 young infants (0–59 days) with Possible Serious Bacterial Infection (PSBI) were identified. Assuming that 10% of all births develop PSBI, we achieve the PSBI treatment coverage of 75% (ref, ref, ref). The majority of these cases (83%) were identified by mothers (Table below).
ASHA Performance
37.1% (1296/3496) did not receive any HBNC visit, 41.7% (1461/3496) of families received at least two visits, while 23.5% (823/3496) received three or more HBNC visits. Among those who received at least one HBNC visit, the average number of visits was 2.34.
In the first week of life, only 36.4% (492/1350) of newborns received one visit, while 63.5% (858/1350) received two or more visits. The average number of ASHA visits during the first seven days are 1.86. Only 11.4% (179/1565) of families being accompanied by an ASHA during facility visits.
Table x: Details of ASHA visitation and her role in identification
| ASHA Performance | |
|---|---|
| Overall ASHA HBNC visits | n(%) |
| No visit | 1296 (37.1) |
| Atleast 2 ASHA visits | 1461(41.7) |
| 3 or more visits | 823(23.5) |
| Average number of HBNC visits (among those who received atleast one visit) | 2.34 visits |
| ASHA visits during first week of life | |
| 1 visit | 492(36.4) |
| 2 or more visits | 858(63.5) |
| Average number of ASHA visits during first 7 days | 1.86 visits |
| Families accompanied by ASHA to health facilities | 179 (11.4) |
Care seeking and place of assessment
Among all sickness episodes, 46.8% of families sought care at government primary health facilities (Ayushman Arogya Mandir, Primary Health Centers, or Community Health Centers). Care-seeking at district hospitals and medical colleges remained low, at only 0.2% and 1.9%, respectively. For PSBI cases, around three-fourths of the affected infants were taken to Community Health Centers for treatment. A small proportion (~5%) received care at Health and Wellness Centers. Notably, 20% of PSBI cases were taken directly to tertiary care facilities.
| Identification, Assessment, Referral, Treatment, and Outcomes of Young Infants Aged 0–59 Days with PSBI by clinical Sub classification | |||||
|---|---|---|---|---|---|
| Parameters | Total infants 0-59 days with PSBI | Infants 0-59 days with Critical Illness | Infants 0-59 days with Clinical Severe Infection | Infants 0-6 days with Fast breathing Only (Severe Pneumonia) | Infants 7-59 days with Fast Breathing Only (Pneumonia) |
| 1. Identification | (n=126) | (n=21) | (n=69) | (n=15) | (n=21) |
| By Mothers | 105 | 13 | 59 | 13 | 20 |
| By Family members | 12 | 1 | 8 | 1 | 2 |
| By Healthcare providers | 7 | 7 | 0 | 0 | 0 |
| During follow-up visit | 2 | 0 | 2 | 0 | 0 |
| 2. Case assessment Facility | 126 | 21 | 69 | 15 | 21 |
| CHC | 96 | 9 | 56 | 14 | 17 |
| HWC | 6 | 1 | 0 | 1 | 4 |
| Other tertiary care facilities | 24 | 11 | 13 | 0 | 0 |
| 3. Assessor at primary healthcare facilities | 102 | 10 | 56 | 15 | 21 |
| Medical officer (MO) | 12 | 2 | 6 | 3 | 1 |
| Community health officer (CHO) | 89 | 7 | 50 | 12 | 20 |
| Staff Nurse | 1 | 1 | 0 | 0 | 0 |
| 4. Referral History (for cases assessed at Primary Health facilities) | |||||
| Advised referral to higher healthcare facilities with pediatric care | 82 | 10 | 56 | 15 | 1 |
| Referral accepted | 33* | 10 | 21 | 1 | 1 |
| Administered prereferral dose | 20 | 5 | 15 | 0 | 0 |
| Number of PSBI cases managed at primary healthcare facilities | 67 | 0 | 33 | 14 | 20 |
| CHC | 62 | 0 | 33 | 13 | 16 |
| HWC | 5 | 0 | 0 | 1 | 4 |
| 5. Treatment compliance for PSBI cases managed with Simplified antibiotic regimen at primary health facilities | |||||
| 5.1. No. of injection gentamicin doses received | |||||
| 7 injections | 22 | - | 22 | ||
| 2-6 injections | 5 | - | 5 | ||
| 1 injection | 0 | - | 0 | ||
| 0 injection | 6 | - | 6 | ||
| 5.2. No. of oral Amoxicillin doses received | |||||
| 14 doses | 41 | - | 24 | 5 | 12 |
| 10-13 doses | 8 | - | 1 | 6 | 1 |
| 1-9 doses | 16 | - | 7 | 3 | 6 |
| 0 dose | 1 | - | 0 | 0 | 1 |
| Other antibiotics received | 1 | - | 0 | 0 | 1 |
| 6. Adherence to simplified antibiotic treatment | |||||
| Treated for 7 days | 38 | - | 21 | 5 | 12 |
| Dropped in between | 28 | - | 11 | 9 | 8 |
| Treated for 7 days with gaps | 1 | - | 1 | 0 | 0 |
| 7. Outcome on Day 8 who received simplified antibiotic regimen at primary healthcare facilities | |||||
| Recovered | 61 | - | 30 | 12 | 19 |
| Still sick | 6 | - | 3 | 2 | 1 |
| Dead | 0 | - | 0 | 0 | 0 |
| 8. Outcome on day 8 for cases who accepted referral to higher facilities | 33 | 10 | 21 | 1 | 1 |
| Recovered | 25 | 10 | 14 | 0 | 1 |
| Still sick | 6 | 0 | 6 | 0 | 0 |
| Dead | 2 | 0 | 1 | 1 | 0 |
| 9. Outcome on day 8 for cases who visited to higher facilities outside the study site | 24 | 11 | 13 | 0 | 0 |
| Recovered | 17 | 6 | 11 | - | - |
| Still sick | 3 | 2 | 1 | - | - |
| Dead | 3 | 2 | 1 | - | - |
| Outcome unknown | 1 | 1 | 0 | - | - |
PSBI Assessment and Referral from Primary healthcare facilities
All the cases assessed at primary healthcare facilities, the majority (89/102, 87%) of them were assessed by community health officers, followed by medical officers (~12%) and one case by staff nurse at CHC. Of the 82 cases advised referral to higher facilities for pediatric care (10 CI, 56 CSI, 15 Severe Pneumonia, 1 Pneumonia), referral acceptance was 40%. A pre-referral dose (injection gentamicin and oral amoxicillin based on subclassification) was administered to 60.1% (20/33) of these cases.
Treatment Compliance and Adherence
A total of 67 PSBI cases (47 who did not accept referral and 20 pneumonia cases) were managed with a simplified antibiotic regimen at primary healthcare facilities (62 at CHCs, 5 at HWCs). Of these, 33 cases were classified as Clinical Severe Infection (CSI), and two-thirds received the complete 7-dose course of injection gentamicin. Cases of Severe Pneumonia (14) and Pneumonia (20) were managed with oral amoxicillin, with 36% (5/14) of Severe Pneumonia cases and 60% (12/20) of Pneumonia cases completing all 14 doses.
Outcome
The treatment outcomes of infants with PSBI and managed with a simplified antibiotic regimen at primary healthcare facilities, as well as those who sought care directly to tertiary healthcare facilities outside the study site, was assessed on day 8 after treatment initiation. Among the 67 infants managed on an outpatient basis at primary healthcare facilities, 91% (61/67) had recovered, while 9% (6/67) were still sick, including three cases of Clinical Severe Infection (CSI), two cases of Severe Pneumonia, and one case of Only Fast Breathing (FB). No deaths were reported among those managed on an outpatient basis.
Among the 33 infants who were referred and received inpatient treatment, 76% (25/33) recovered, while 18% (6/33) were found sick on day 8. Mortality was found in 6% (2/33) of cases (1 CSI, 1 severe pneumonia).
In contrast, of the 24 infants who went directly to tertiary care facilities outside the study site, 70.8% (17/24) recovered, while 12.5% (3/24) remained sick. Mortality was found highest in this group, with 12.5% (3/24) of cases resulting in death, and for one case, the outcome was unknown. For two cases (CSI) where the family left the facility without informing, one case was found healthy and one was still sick on the day 8 outcome.
Formative Phase understanding
During the formative phase, only 3 Ayushmaan Arogya Mandir had basic infrastructure which still lacked water & electricity supply. CHC was the only facility that operated at some level, but due to the lack of quality of services & unavailability of healthcare providers, it catered marginally to a minuscule population. There was no NBSU, and a pediatrician was also available 2 days a week based on facility observation during qualitative immersion. The nearest healthcare service available for newborns was a well trusted private hospital 26 Kms away from the block while the government medical college 32 Kms away, the district hospital was not the preferred choice of facility and was farther away than the medical college (37 Kms). Therefore, the community primarily had to rely on UMP and private hospitals due to 24X7 availability of services and perceived good quality of care, or they reached out to traditional healers owing the community’s faith & beliefs. The table (3) below highlights the various barriers at the system level, community level that led to development of the strategic themes for the model.
| System Context | Community Context | Solutioning Focus | Strategic Themes |
* Identification was expected to happen through HBNC visitations by ASHA
|
* Mother/Caregivers were not aware of PSBI danger signs in newborns.
|
* Develop a mechanism for identification of sick babies from the birth cohort.
|
Making all sick babies visible |
* The sick young infants were not managed at primary healthcare facilities due to suboptimal resources including absence of healthcare providers and infrastructure.
|
* Services at public health facilities were deemed poor in quality as they did not even
“touch the baby for examination” |
* Need for a system for preliminary screening and triaging to expedite care seeking at appropriate facilities.
|
Screening & Assessment of all notified infants |
* ASHA had no role in referral as she was not involved in newborn care by family or through HBNC visitations.
|
* There was no guidance for where to seek care, the community relied on word of mouth or relatives & elderly for best care practices and treatment places.
|
* A mechanism for counseling the family for mobilization to a forma lheathcare facility.
|
Facilitating care seeking & management |
* There were no formats or SOP’s for documenting case history or treatment regimen or registration/preliminary records of YI who were cared for at the facilities.
|
* Services for sick young infants (SYIs) were available 2 days/week when a pediatrician was present.
|
Family is to be nudged for adherence, follow-up until the desired health outcome is achieved. | Coordinate home care/ outpatient care/inpatient care |
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Observation of PSBI cases-classified and managed at Primary Healthcare facilities xx
Of all the cases that were assessed, classified as PSBI and managed at primary healthcare facilities of the study block, 85% were directly observed by the IMNCI trained facility monitoring team. The objective of these observations was to assess the quality of assessments by healthcare providers and ensure the availability of necessary equipment and consumables to manage PSBI cases at primary healthcare facilities. The majority of cases (95%) were assessed at the Community Health Center (CHC), with Community Health Officers (CHOs) being the primary assessors in most of the cases (86%).
During the initial quarter of operationalization (post-training), digital thermometers were available in only 30% of cases. However, availability improved over time through indenting, and by the third quarter, all cases were assessed using a digital thermometer. Throughout the study period, all cases assessed at the CHC were weighed using an analog weighing scale. ARI timers were not available in the health system supply, so mobile phone timers were initially used to count the respiratory rate in young infants. Later, these were replaced by the IMNCI application, which has an inbuilt timer for respiratory rate counting.
Consumables such as injection gentamicin, syringes (1 ml, 3 ml), and needles (23 gauge) were available only at the CHC, whereas oral amoxicillin was available at all primary healthcare facilities, including Ayushman Arogya Mandirs (AAMs), Primary Health Centers (PHCs), and the CHC, at the time of case observation. The modified PSBI treatment card was properly filled out for approximately 91% of cases. However, for ~8% of cases, assessors did not mention all the required information in the treatment card, like the address of family and contact number, the infant's current weight (although it was measured), or the correct subclassification of PSBI. Additionally, for about 1% of cases, the PSBI treatment card was not filled at all, as the infants were referred immediately after birth.
Among the cases managed by CHO, e-sanjeevani for teleconsultation was utilized by only ~3% (2/74) of them, in which the consultation was done only in one case where MO was available for providing teleconsultation to CHO on e sanjeevani on the other side. 7% (5/74) among all CHO and 6% (4/72) among those who did not utilize e-sanjeevani, did teleconsultation with medical officers via call. During the initial phase of operationalization, the measurement of vitals in sick young infants (SYIs) was inconsistent (graph), with the implementation support team often stepping in, particularly for weight assessment. However, over time, adherence to vital assessments improved significantly. By the third quarter, nearly all SYIs had their weight, temperature, and respiratory rate measured as part of routine clinical practice.
Graphs (X) shows that while assessing infants according to the IMNCI protocol, assessors investigated feeding problems, chest indrawing, and lethargy in almost all sick young infants. In approximately 90% of cases, they inquired about the history of convulsions. Inquiry about jaundice and diarrhea was conducted in nearly three-fourths of cases. Although this improved over time, jaundice and diarrhea were still not assessed in 13% of cases each, despite adherence to the IMNCI protocol.
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Discussion
The study elicits the feasibility of implementation of community-based management of sick young infants (aged 0-59 days) with PSBI at primary healthcare facilities when referral is not feasible. The PSBI identification coverage during the implementation phase was 71%, which was comparable to the identification rates reported in Palwal, Haryana (70%) (ref). It is higher than Ntcheu, Malawi (63.8%) (ref), Pune (57%) (ref), Lucknow (53%) (ref) and Kushtia, Bangladesh (31%) (ref) and lower than Zaria, Nigeria (95.5%) (ref), Pakistan (95%) (ref), Mekelle, Ethiopia (87%) (ref).
This study underscores the importance of addressing barriers to care seeking and a need for community engagement beyond the home visits by health workers which have reportedly been low in coverage even with substantial program support (ref. A notable strength of this study was the active engagement of mothers and families as primary reporters of illness to improve the coverage and timeliness of care seeking. It also focussed on empowering these mothers around the decision making and hand holding in “stepping up” and seeking care . This intervention of introducing a Central Care Coordination System (CCCS) or SakshaMa helpline, filled the current need of encouraging uptake of the service by caregivers through community-based sensitization (ref, ref, ref, ref, ref). However, there is a need to further optimize this process for scalability and cost effectiveness. ASHA contributed to a substantial proportion (18%) of illness episodes and emphasizes their pivotal role in early identification and linkage to formal healthcare services. Her positioning, and potential of home based newborn is promising, however, improving its coverage and quality is an area that needs further exploration and innovation.
Another aspect highlighted through the study was the preferred utilization of primary health facilities (46.6%). The availability of quality services at these facilities was a major motivating factor for the community to seek care from these facilities. It is interesting to observe the trends of the referral acceptance, wherein, cases with Critical Illness had 100% acceptance while the referral acceptance was lower among cases of Clinical Severe Infection (CSI) at 36% (20/55), and notably minimal for severe pneumonia cases, with only 6.7% (1/15) referral acceptance.
This possibly indicates that caregivers only prefer tertiary care facilities and inpatient treatment pathway when they perceive the “severity of illness” to be high. There are other multiple aspects to this acceptance such as the effectiveness of counselling, fear of out-of-pocket expenses, distance etc. (ref). The helpline played a critical role in this piece by prioritizing patient admission through coordination with facility nodal, ensuring bed availability at the tertiary facility, and providing the necessary handholding support to these families in navigating through the “unknown” set up. Despite these interventions, there is a substantial population that is seeking care through informal practitioners and not seeking care outside home for newborn illness (10.3% and 14.4%, respectively) highlights the need to design more comprehensive approach for this population that was reported in other studies also as a missed opportunity for PSBI identification & management (ref, ref, ref, ref, ref, ref). Although the study was designed to handhold the community to redirect the care seeking towards public health facilities, it was observed that nearly one-fourth (24%, 30/124) of cases were reaching the facility for care seeking by themselves once the services were established at primary healthcare facilities which were operationalised in the later part of the implementation phase, and the information spread through word of mouth in the study area.
The case fatality rate (CFR) found in the current study was 4% (5/124), which is considerably lower than the global pooled estimate of 9.8% for PSBI infants. Moreover, there were no reported deaths among the PSBI cases managed as outpatients at primary healthcare facilities with a simplified antibiotic regimen, indicating the potential effectiveness and safety of this approach in this setting. However, five deaths occured in infants that were referred and treated at tertiary care facilities out of which three infants that had comorbidities besides PSBI.
Another major progress which is significant programmatically and from a service delivery perspective is the inclusion of Community Health Officers for administration of antibiotics under the supervision of Medical officers as most of the previous study highlight at the limitation by the Auxiliary Nurse Midwives both in terms of their competency and operational challenge of not being able to operate from the sub-centres throughout the week. This inclusion is in line with the newly launched SAANS guideline as well as the AB-AAM initiative to improve the outreach of health system delivery. However, the treatment administration from AB-AAM for PSBI cases requiring injectable drug administration still remains a challenge at these centres and such cases need to be referred to CHC for simplified antibiotic regimen. CHOs hold promise for bridging the care gap in pediatric expertise at the community level, ensuring timely assessment, classification, and management of young infants' illnesses.
Unlike previous studies, this study adopted a bottom-up approach and did not rely on the Technical Support Unit for review and monitoring or technical supervision. On the contrary, this study relied on utilising existing resources at the block level and leveraged them under the leadership of the Medical Officer In Charge for complete ownership of programmatic implementation of case assessment, management and facility operationalisation. However, we acknowledge the scope of a monitoring body at the district and state level from a perspective of scale up across the district.
The limitation of this study is that despite intensive efforts with ASHA and other frontline workers, we could not establish a mechanism of follow up of young infants with PSBI in the community. This challenge was particularly notable among cases of PSBI with only fast breathing, crucial for adherence to the course of antibiotic treatment (ref). Also, active efforts to improve care seeking through two strategies: the community outreach of the helpline, and ASHA workers' both of which emerged as a critical driver for formal care-seeking, are promising strategies can be scaled to other settings with limited healthcare access. But despite these strategies also, a significant population does not adhere to care seeking advice due to complex intertwined belief and information systems at the community level that are influenced by their understanding of disease etiology and the level of trust in public health facilities.
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