Comparison of two modes of non-invasive ventilation in preterm babies
Completed
- Conditions
- Respiratory distress syndrome at birthRespiratory
- Registration Number
- ISRCTN11928413
- Lead Sponsor
- Section of Neonatology of the Portuguese Society of Paediatrics
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
1. Infants with gestational age (GA) between 27 weeks and 32 weeks + 6 days
2. Either gender
3. Parents had signed an informed consent before delivery
4. Don't need endotraqueal intubation at birth
Exclusion Criteria
1. Need of endotraqueal intubation in the delivery room
2. Major congenital malformations
3. Neuromuscular diseases
4. Perinatal asphyxia ( Apgar < 4 at 5 minutes and base excess of > -12 in the first hour)
5. Early onset sepsis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome of our study was the need of invasive ventilation within the first 120 hours of life. Intubation criteria were: pH <7.25, pCO2> 65 mmHg, SatO2 <88% with FiO2 = 40%, one episode of apnoea requiring bag -and-mask ventilation, frequent episodes of bradycardia/apnoea (>2-3 per hour).
- Secondary Outcome Measures
Name Time Method 1. Duration of mechanical ventilation<br>2. Use of surfactant<br>3. Incidence of pneumothorax<br>4. Bronchopulmonary dysplasia (BPD- defined as need of oxygen supplementation at 36 weeks of gestation)<br>5. Peri and intraventricular haemorrhage (Volpe grades III/IV)<br>6. Necrotizing enterocolitis ( Bell´s stage >2)<br>7. Severe retinopathy of prematurity (grade >2)<br>8. Patent ductus arteriosus (PDA)<br>9. Sepsis (defined as positive hemoculture<br>10. Clinical signs and intention to treat)<br>11. Length of stay and mortality<br><br>The outcomes were measured throughout the hospitalisation period.