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Develop and implement a scalable model for improving the identification and management of possible serious bacterial infections in young infants in Uttar Pradesh, India

Implementation research to develop and evaluate a mother-infant-centred, pandemic-resilient, scalable model for improving the identification and management of possible serious bacterial infections in young infants in Uttar Pradesh, India

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN10382343
Enrollment
2828
Registered
2022-11-10
Start date
2023-05-02
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Possible serious bacterial infections in young (<2 months old) infants Infections and Infestations

Interventions

This study is designed as a mixed methods implementation research that will involve human-centred design techniques to co-design the PSBI implementation model with relevant stakeholders as an integrat
annual live birth cohort approx. 3000) of Kanpur Nagar district. An integrated care pathway will be co-designed with various stakeholder groups and will include: (a) health system interventions to im

Sponsors

World Health Organization, Geneva
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: All 0-59 day old infants born to usual residents in the study area

Exclusion criteria

Exclusion criteria: Does not meet the inclusion criteria

Design outcomes

Primary

MeasureTime frame
1. Scalable model/proof-of-concept to improve identification and management of PSBI at a population level at each 3 months of the total of 4 cycles. This is a non-quantifiable, descriptive outcome, which will describe the entire PSBI model as implemented. 2. Coverage of PSBI identification in the target population (against an assumed PSBI incidence of 10% among all young infants) will be assessed based on programmatic data - the number of cases notified to the system and confirmed as PSBI as a fraction of all infants in the population who have completed 2 months of follow-up.

Secondary

MeasureTime frame
1. Effective coverage of PSBI estimated through cascade analysis with the target population: 1.1. Population in need: This is the number of infants among all study participants who were reported to have ANY illness in the previous 15 days, as assessed on days 15, 30, 45, and 60 (mother's report) 1.2. Service contact coverage, defined as the proportion of the population in need that contacts a health service. This will be measured as the proportion of infants among the population in need who had any contact with the helpline or an ASHA worker or any other designated health functionary with regards to the illness and will be assessed on days 15, 30, 45, and 60, as well as programmatic records. 1.3. Input-adjusted coverage, defined as the proportion of the population in need that contacts a health service that is ready. Health service readiness (numerator) will be assessed based on whether the contact with the health service translated into an assessment where the infant was assessed for PSBI and other danger signs. The numerator will be derived from the helpline records which will be updated in real time if and when the assessment is done. The denominator will be the same as the population in need. 1.4. Intervention coverage, defined as the proportion of the population in need that receives health service. This will be calculated as infants who have initiated treatment out of those infants who were confirmed to have PSBI (the "population in need" indicator for subsequent coverage indicators in the cascade will be reset to those infants who were confirmed to have PSBI). The numerator and denominator will be derived from programmatic records, and the numerator will be verified against the mother's report of treatment initiation from evaluation follow-up on days 15, 30, 45 or 60. 1.5. Quality-adjusted coverage, defined as the proportion of the population in need that receives health service according to standards. The numerator (whether care received was as per standards

Countries

India

Contacts

Public ContactVinay Pratap Singh
vinaypratap.singh@celworld.org+91 (0)9818000252

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026