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Effect of iKMC on mortality and sepsis in neonates in district hospitals

Effect of immediate kangaroo mother care (iKMC) on neonatal mortality and culture-positive sepsis in low birth weight neonates in district hospitals in Chhattisgarh, India: a stepped-wedge cluster randomized trial - Nil

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/09/074269
Enrollment
4730
Registered
2024-09-24
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Health Condition 1: P369- Bacterial sepsis of newborn, unspecified Health Condition 2: P071- Other low birth weight newborn

Interventions

Intervention1: Immediate Kangaroo mother care (iKMC): 1. iKMC is immediate and continuous KMC, which means KMC will be started soon after birth (within 12 hrs of life) and to be given continuously - f

Sponsors

All India Institute of Medical Sciences, New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All live low birth weight (1000-1799 g) neonates admitted to the study hospitals, irrespective of place of birth, in whom KMC can be initiated within 12 hours of life.

Exclusion criteria

Exclusion criteria: Neonates born to mothers who are unwilling to provide consent or whose mother is sick and unlikely to be able to provide KMC within the first three days after birth, Neonates who require intubation and mechanical ventilation or inotropes for shock within the first 12 hours of life, Neonates born to mothers younger than 18 years of age, Triplets or higher-order births, Major congenital malformation that interferes with the intervention

Design outcomes

Primary

MeasureTime frame
Incidence of all-cause neonatal mortality and/or culture-positive sepsis among neonates with birth weights of 1000-1799 g and admitted to level-2 units of the district hospitals until discharge or 28 days of life, whichever is earlierTimepoint: Until discharge or 28 days of life, whichever is earlier

Secondary

MeasureTime frame
Early and late neonatal mortality rateTimepoint: 7 and 28 days of life;Incidence of early-onset culture positive sepsisTimepoint: 72 hours of life;Incidence of late-onset culture-positive sepsisTimepoint: 28 days;Incidence of clinical sepsisTimepoint: 28 days;Pathogen profile and antimicrobial resistance pattern in neonates with culture-positive sepsisTimepoint: 28 days;Exclusive expressed breast milk feeding or exclusive direct breastfeedingTimepoint: At discharge;Skin and gut colonization of the neonatesTimepoint: Day 3 and day 7

Countries

India

Contacts

Public ContactM Jeeva Sankar

All India Institute of Medical Sciences, New Delhi

jeevasankar@gmail.com9818398928

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Apr 4, 2026