asal interfaces for CPAP- what is best for the preterm infant?
Not Applicable
Completed
- Conditions
- Health Condition 1: null- Preterm infants between 26-32 weeks gestation requiring continuous positive airway pressure
- Registration Number
- CTRI/2012/08/002868
- Lead Sponsor
- All India Institute of medical sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 72
Inclusion Criteria
Preterm babies of 26+0 â?? 32+6 weeks of gestation
Respiratory distress requiring CPAP within 6 hours of life
Informed parental consent
Exclusion Criteria
Major congenital malformations
Any known anomaly known to interfere with delivery of CPAP such as congenital diaphragmatic hernia, trachea oesophageal fistula, choanal atresia, cleft palate and nasal deformities, severe cardiovascular instability.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Area under the curve of FiO2 against time during the first 72 hours of CPAP application <br/ ><br>2. Mean FiO2 requirement at 24 , 48 and 72 hours of CPAPTimepoint: 1. Area under the curve of FiO2 against time during the first 72 hours of CPAP application <br/ ><br>2. Mean FiO2 requirement at 24 , 48 and 72 hours of CPAP
- Secondary Outcome Measures
Name Time Method 1.Proportion of babies requiring intubation in the first 72 hours of life <br/ ><br>2.Proportion of babies who develop nasal trauma <br/ ><br>3. Physiological variables including the mean respiratory rates and heart rates as well as Silvermanâ??s score during the first 72 hours <br/ ><br>4.Incidence of oxygen dependency at 28 days postnatal life, air leaks <br/ ><br>Timepoint: Physiological variables are measured at baseline and at 1, 2, 6, 12, 18, 24 hours and every 6th hourly thereafter until 72 hours of CPAP. Nasal trauma will be graded by an independent observer daily during first 72 hours till CPAP is removed