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Using mothers first milk in the babys mouth to help prevent infections in sick newborns admitted to NICU: A research study

Application of buccal mucosal colostrum for first 48 hours of life to nenonates admitted in neonatal intensive care unit to prevent late onset neonatal sepsis within 14 days of life in a tertiary care hospital: A rondomised controlled trial - BUCCAL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/07/091053
Enrollment
200
Registered
2025-07-16
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

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

Interventions

Intervention1: Buccal Mucosal Colostrum Administration: Neonates in this group will receive small amounts (approximately 0.2 0.5 ml) of freshly expressed maternal colostrum applied gently to the bucca

Sponsors

Maharaja Agrasen Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All neonates admitted to NICU within 6 hours of life

Exclusion criteria

Exclusion criteria: 1 Neonates with major congenital anomalies requiring immediate surgical intervention 2 Neonates with early onset sepsis 3 Neonates where colostrum from mother is not available within first 6 hours 4 Neonates born from HIV positive mother 5 Neonates in whom feeding can be initiated within 48 hours of life 6 Neonates whose mother refuse to give consent

Design outcomes

Primary

MeasureTime frame
Incidence of late onset sepsis(defined as sepsis occuring after 72 hours of life)Timepoint: Incidence of late onset sepsis(defined as sepsis occuring after 72 hours of life) within 1 week, 10 days and 14 days of life

Secondary

MeasureTime frame
A. Incidence of NEC within 2 weeks B. Duration of hospital stay in days C. Mortality rate within 2 weeks Timepoint: 2 weeks

Countries

India

Contacts

Public ContactDr Karnika Agrawal

Maharaja agrasen medical college,

karnika.pediatrics@gmail.com8059784475

Outcome results

None listed

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