A trial comparing between bubble Continuous Positive Airway Pressure and jet Continuous Positive Airway Pressure as method of giving Continuous Positive Airway Pressure in respiratory distress in preterm baby less than 34 weeks of gestatio
- Conditions
- Health Condition 1: null- preterm baby less than 34 weeks of gestation with respiratory distress onset less than 6 hours of life
- Registration Number
- CTRI/2011/10/002078
- Lead Sponsor
- PGIMER Chandigarh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 100
1.All inborn neonates of gestational age less than 34 weeks
2. Respiratory distress (defined as presence of at least two out of three signs: tachypnea more than 60/minute, intercostal and/or subcostal retractions, and expiratory grunt)
3. Onset of respiratory distress within 6 hours of life.
4. Baby can be shifted to Neonatal Intensive Care Unit within 12 hours of life
1.Infants who are intubated soon after birth
2.5 minute Apgar score less than/ equal to 3
3.Life threatening congenital malformations
4.Conditions were Continouus Positive Airway Pressure is absolutely contraindicated: poor spontaneous 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 >55mm Hg), massive pulmonary hemorrhage, malformations like congenital diaphragmatic hernia, trachea-esophageal fistula, Pierre-Robinson syndrome, and choanal atresia
5.Parents not willing for neonatal intensive care unit (NICU) care and hence refused consent
6.Non availability of bed in NICU within 12 hours of life
7.If at least one each of the CPAP delivery devices is not available in NICU
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Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Failure of CPAP in first 72 hours of life <br/ ><br>Timepoint: 72 hours of life <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1.Failure of CPAP within 7 days <br/ ><br> <br/ ><br>2.Duration of CPAP support <br/ ><br>3.Duration of oxygen <br/ ><br>Timepoint: 7 day of life;1.Nasal trauma (all severity) <br/ ><br>2.Nasal trauma of moderate and severe degree of severity <br/ ><br>3. Frequency of dislodgements <br/ ><br>4. Pain scoreTimepoint: Till discharge;1.Pulmonary air leaks <br/ ><br>2.CPAP Belly <br/ ><br>3.Death during hospital stay <br/ ><br>4.Proven and probable sepsis <br/ ><br>5.Complications of prematurity: chronic lung disease (marked by the need for supplemental oxygen at 36 weeks? postmenstrual age), intraventricular hemorrhage, periventricular leukomalacia, retinopathy of prematurity, necrotizing enterocolitis, patent ductus arteriosus (clinical and/or echo proven) <br/ ><br>Timepoint: till discharge