Avoid Mechanical Ventilation: The AMV-trial
Completed
- Conditions
- Respiratory distress syndrome of preterm infantsNeonatal DiseasesRespiratory distress syndrome of newborn
- Registration Number
- ISRCTN05025922
- Lead Sponsor
- Schleswig-Holstein University Hospital (Universitatsklinikum Schleswig-Holstein) (Germany)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 210
Inclusion Criteria
1. Preterm infants with a gestational age between 26 weeks + 0 days and 28 weeks + 6 days
2. Birth weight below 1500 g
3. Age less than 12 hours
Exclusion Criteria
1. Lethal malformations
2. Prior surfactant treatment without intubation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome is a combined parameter which is measured between the 25th and 72nd hour of life (day 2 and 3 of life). The primary endpoint is positive if an infant is: <br>1. Intubated and ventilated between the 25th and the 72nd hour of life<br>2. Fraction of inspired Oxygen (FiO2) is greater than 0.6 for more than two hours between the 25th and the 72nd hour of life (to keep oxygen saturation above 85%)<br>3. Partial pressure of Carbon Dioxide (pCO2) greater than 65 mmHg for more than two hours between the 25th and 72nd hour of life
- Secondary Outcome Measures
Name Time Method 1. Ventilation rate<br>2. Intraventricular Haemorrhage (IVH)<br>3. Periventricular Leukomalacia (PVL)<br>4. Bronchopulmonary Dysplasia (BPD)<br>5. Death<br>6. Operation due to retinopathy (Retinopathy Of Prematurity [ROP])<br>7. Patent Ductus Arteriosus (PDA)<br>8. Necrotising Enterocolitis (NEC)<br>9. Intestinal perforation<br>10. Hydrocephalus and ventricular-peritoneal-shunt<br>11. Number of surfactant doses<br>12. Total surfactant (mg/kg bodyweight)<br>13. Days on assisted ventilation<br>14. Days on supplemental oxygen<br>15. Duration of hospitalisation<br>16. Weight gain per day<br>17. Pneumothorax<br>18. Other complications of prematurity <br><br>All outcomes will be measured until discharge. Bronchopulmonary dysplasia will be assessed at 36 weeks + 0 days (+/- 5 days) of corrected gestational age.