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

This study is a parallel group randomized controlled trial conducted in the Neonatal Intensive Care Unit of Government Medical College and Hospital Chandigarh. The study aims to evaluate the effect of intranasal instillation of mothers own breast milk on nasal bacterial colonization patterns in preterm neonates receiving non invasive ventilation. Preterm infants with gestational age between 27 plus 0 and 32 plus 6 weeks who require non invasive ventilation within the first 48 hours of life will be enrolled after obtaining written informed consent from parents.

Eligible neonates will be randomized into two groups. The intervention group will receive intranasal instillation of mothers own breast milk at a dose of 0.1 ml in each nostril three times daily until discontinuation of non invasive ventilation. The control group will receive standard nasal care as per unit protocol. Both groups will otherwise receive identical standard neonatal care.

Nasal swabs will be collected at baseline within two hours of starting non invasive ventilation before the first intervention then at 24 to 48 hours and again on day seven or at discontinuation of non invasive ventilation whichever occurs later. The primary outcome is the pattern of nasal bacterial colonization including commensal and pathogenic organisms assessed by culture and sensitivity testing. Secondary outcomes include duration and failure of non invasive ventilation incidence of ventilator associated pneumonia clinical and culture proven sepsis and other major neonatal outcomes such as necrotizing enterocolitis bronchopulmonary dysplasia retinopathy of prematurity intraventricular hemorrhage feeding intolerance and mortality before discharge. Neurodevelopmental outcomes will be assessed at three to five months corrected age using standardized tools and brain volume assessment on MRI at term equivalent age will be performed in a subset of infants.

The study hypothesizes that intranasal application of breast milk will favorably modify nasal microbial colonization by increasing commensal flora and reducing pathogenic organisms through local mucosal immunomodulatory effects. The findings of this study may provide evidence for a simple low cost intervention to reduce respiratory infections and improve outcomes in preterm neonates on non invasive ventilation.