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Home-based newborn care delivered according to risk level to reduce infant deaths: A randomized trial

Risk-differentiated home-based care to reduce infant mortality: an individually randomized trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/10/095751
Enrollment
12000
Registered
2025-10-08
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

None listed

Interventions

Intervention1: Interventions for moderate-risk infants: Risk categorization Gestational age 35 to 37 weeks OR Birth weight 1800â??2499 g OR Nursery stay immediately postpartum 48â??72 hours OR Respira
D14
D28
5m Interventions Interventions for the low-risk infants + Expressed breastmilk feeding, if indicated Counselling and support of Kangaroo mother care(KMC) if low birth weight or preterm Counselling fo

Sponsors

Dr Sunita Taneja
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Caregiver (usually the mother) consents to participate in the study Age within 7 days of birth

Exclusion criteria

Exclusion criteria: Mother and baby intend to leave the study area within the next 6 months Infants admitted to the hospital for longer than 7 days of life. Major congenital abnormalities that are lethal, e.g., trisomy 13 or 18, or that will require major early intervention such as surgery and sustained hospital follow-up, e.g., complex cardiac conditions. Mothers or the infants themselves are participating in any other intervention study

Design outcomes

Primary

MeasureTime frame
MortalityTimepoint: First 6 months of life

Secondary

MeasureTime frame
Breastfeeding practicesTimepoint: 1, 3, 6 (150-170 days) months of age;MorbiditiesTimepoint: 1,3,6 months of age (2 weeks recall);Treatment-seeking behaviors Timepoint: 1,3,6 months of age (2 weeks recall);Hospitalization for illness from birth 6 months of age Timepoint: 1,3,6 months of age (2 weeks recall);Weight Timepoint: 6 months of age

Countries

India

Contacts

Public ContactSunita Taneja

Society for Applied Studies

ranadip.chowdhury@sas.org.in0114604375155

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026