Health Condition 1: P22- Respiratory distress of newborn
Conditions
Interventions
Intervention1: Nasal mask group: Preterm infants requiring non-invasive positive pressure ventilation will receive the ventilation through appropriate sized nasal mask till 72 hours after initiating t
Sponsors
Institute of Post Graduate Medical Education and Research Department of Neonatology
Eligibility
Inclusion criteria
Inclusion criteria: 1.Preterm newborn (gestational age of 2.Preterm newborn requiring NIPPV after extubation within first 7 days of life.Thus any preterm baby undergoing extubation will also be eligible and will be supported with non-invasive positive pressure ventilation as per study protocol
Exclusion criteria
Exclusion criteria: 1.Presence of lethal congenital malformation or suspected chromosomal anomaly 2.Outborn preterm infants 3.Contraindications of non-invasive ventilation (shock requiring inotropes, cleft lip and palate, choanal atresia, severe perinatal asphyxia with APPGAR at 5 min of 3 or less) 4.Parental refusal of consent for participation in the study 5.Babies already on any form of non-invasive ventilation (continuous positive airway pressure or non-invasive positive pressure ventilation or heated humidified high flow nasal cannula) before randomization. Thus baby who is already on continuous positive airway pressure and require because of continuous positive airway pressure failure will not be included in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the incidence of non-invasive positive pressure ventilation failure requiring intubation and mechanical ventilation within 72 h of initiating respiratory support in preterm newborn in three different groups (continuous nasal mask versus continuous short bi nasal prong versus prong and mask in rotation).Timepoint: 72 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| complications of non -invasive ventilation (feed intolerance, pulmonary air leak, gastrointestinal perforation, ventilator associated pneumonia)Timepoint: Before discharge or death;Duration of neonatal intensive care unit stay in each groupTimepoint: Before discharge or death;Duration of non-invasive positive pressure ventilation or mechanical ventilation in each groupTimepoint: Before discharge or death;Incidence of nasal trauma as per nasal injury scoring chartTimepoint: 72 hours;Mortality in each groupTimepoint: Before discharge;Oxygen and mean airway pressure (MAP) of non- invasive positive pressure ventilation requirement in each groupTimepoint: 72 hours;To compare the incidence of common neonatal morbidities ( bronchopulmonary dysplasia, necrotizing enterocolitis, sepsis, retinopathy of prematurity, intraventricular hemorrhage, patent ductus arteriosus, ventilator associated pneumonia)Timepoint: Before discharge or death | — |
Countries
India
Contacts
Public ContactSomnath Pal
Institute of Post Graduate Medical Education and Research
Outcome results
None listed