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Effect of applying mother s breast milk into the nose on infection-related germs in premature babies receiving breathing support

Effect of intranasal breast milk instillation on nasal bacterial colonization in preterm neonates on non-invasive ventilation: a randomized controlled trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/01/101084
Enrollment
110
Registered
2026-01-14
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Health Condition 1: P220- Respiratory distress syndrome of newborn

Interventions

Intervention1: Human breast milk: Intranasal breastmilk instillation for those neonates requiring non invasive ventilation. Breast milk to be taken from neonate s own mother and intervention will be s

Sponsors

Government medical college and hospital Chandigarh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All babies born with gestation age 27+0 to 32+6 weeks requiring NIV within 48 hours of life will be enrolled

Exclusion criteria

Exclusion criteria: 1. Babies with severe congenital malformation or chromosomal anomalies 2. Structural anomalies like choanal atresia, cleft palate with nasal involvement, nasal septal deviation or facial trauma at birth 3. Infants receiving intranasal medications other than nasal saline drops 4. Refuse to give consent. 5. Neonates with confirmed or suspected congenital syphilis (especially infants presenting with nasal discharge or snuffles ). 6. Neonates with suspected TORCH infections 7. Severe birth asphyxia ( APGAR less than or equal to 3 at 5 minutes)

Design outcomes

Primary

MeasureTime frame
Effect of intranasal breast milk application on bacterial colonization patterns in nasal cavity of preterm neonates with gestation age 27 +0 to 32 +6 weeks on non-invasive ventilationTimepoint: Before starting non invasive ventilation till the neonate is on non invasive ventilation

Secondary

MeasureTime frame
failure of non-invasive ventilation and it s overall durationTimepoint: From start of non invasive ventilation till its failure or weaning;rate of infections, including ventilator-associated pneumonia (VAP) and sepsisTimepoint: From the start till weaning of non invasive ventilation;neurological outcomes, including MRI brain and neurodevelopmental assessment age using the HINE or ASQ-3 (in case of loss to follow-up).Timepoint: MRI At 40 weeks corrected gestation age and neurodevelopment assessment at 3 -5months corrected gestation age;incidence of other major neonatal morbiditiesTimepoint: During hospital stay

Countries

India

Contacts

Public ContactDr SHIVI SAXENA

Government medical college and hospital, sector 32, Chandigarh

dr.sukshamj@gmail.com9988901596

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026