'Early selective treatment of RDS with Curosurf guided by lamellar body counts

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2006
INTERVENTION: Randomisation to: 1. Selective treatment with Curosurf 200 mg/kg (intubation and extubation) 1‐2 h after birth, guided by LBC 2. Classical Scandinavian regimen i.e. treatment with Curosurf 200 mg/kg (intubation and extubation) 5‐6 h after birth when a/APO2 decreases below 0.36 Trial start and end dates were amended on 24/09/09 (used to be 01/09/06 to 01/03/08). As of 28/06/2011 the end date has again been extended from 31/12/2010 to 01/08/2011. CONDITION: Respiratory distress syndrome (RDS) and gestational age less than 30 weeks ; Respiratory ; Respiratory distress syndrome PRIMARY OUTCOME: Mechanical ventilation or death within the first 5 days of life SECONDARY OUTCOME: 1. Mortality before discharge; 2. a/APO2 after 6 days; 3. Mechanical ventilation before discharge; 4. Pneumothorax; 5. Lung haemorrhage; 6. Diastolic arterial pressure (DAP); 7. Necrotising enterocolitis (NEC); 8. Chronic lung disease (CLD) or bronchopulmonary dysplasia (BPD); 9. Intraventricular hemorrhage (IVH); 10. Periventricular leukomalacia (PVL); 11. Retinopathy of prematurity (ROP); 12. Duration of oxygen treatment (days); 13. Duration of nasal CPAP (days); 14. Duration of mechanical ventilation (days) INCLUSION CRITERIA: 1. Gastric aspirate (GA) 24 + 0 to 29 + 9 weeks 2. Early nasal CPAP 3. Gastric aspirate obtained not later than 45 min after birth 4. Informed consent before birth or latest 1 h after birth
Epistemonikos ID: ddccaa506fde9ef7b52ad4fe195c10a9da42ec47
First added on: Aug 21, 2024