Health Condition 1: P220- Respiratory distress syndrome of newborn
Conditions
Interventions
Sponsors
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
| Measure | Time 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
| Measure | Time 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
Government medical college and hospital, sector 32, Chandigarh