Will intermittent changing of nasal interfaces reduce nasal injury in neonates on CPAP? - A randomized control trial
- Conditions
- Health Condition 1: null- Respiratory distress syndrome
- Registration Number
- CTRI/2017/04/008368
- Lead Sponsor
- Fernandez Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 192
All inborn neonates less than 31 weeks of gestation and developed respiratory distress (presence of at least two out of three signs: tachyp-nea >60/min, intercostal retractions, and expiratory grunt) within 6 hours of life
Neonates with Perinatal depression (5 minute Apgar score of <=3), Life threatening congenital malformations such as congenital diaphragmatic hernia, and trachea-esophageal fistula, other malformations that would prevent from estab-lishing CPAP due to the anatomical defect such as Pierre-Robinson syndrome and choanal atresia
and Conditions where CPAP would be contraindicated such as neonates with poor spon-taneous respiratory efforts or apnea, worsening shock, suspected or proven persistent pulmonary hypertension of newborn, severe metabolic acidosis (pH <7.2 with base deficit >-10), severe respiratory acidosis (pH <7.2 with PaCO2 >55mmHg) and mas-sive pulmonary hemorrhage
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence and severity of nasal injury at removal of CPAP and at discharge from the NICU based on the objective scoring and a subjective assessmentTimepoint: At stoppage of CPAP
- Secondary Outcome Measures
Name Time Method Duration of CPAPTimepoint: Discharge;incidence of bronchopulmonary dysplasiaTimepoint: Discharge;Intraventricular hemorrhageTimepoint: Discharge;Need for mechanical ventilationTimepoint: 7 days;Periventricular leukomalaciaTimepoint: Discahrge;Ventilator associated pneumoniaTimepoint: Till 2 days after removal of CPAP