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

Completed

• Conditions: Respiratory distress syndrome (RDS) and gestational age less than 30 weeks; Respiratory; Respiratory distress syndrome

• Registration Number: ISRCTN41781424
• Lead Sponsor: Individual Sponsor (Denmark)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05-08
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 380

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

Exclusion Criteria

1. Prolonged rupture of the membranes >3 weeks
2. Therapeutic infusions in the amniotic cave
3. Lethal malformations
4. Intubation in the delivery room or before randomisation
5. Meconium or pus contamination of the gastric aspirate
6. The neonatal ward too busy with other patients
7. No gastric aspirate

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mechanical ventilation or death within the first 5 days of life

Secondary Outcome Measures

Name	Time	Method
1. Mortality before discharge<br>2. a/APO2 after 6 days<br>3. Mechanical ventilation before discharge<br>4. Pneumothorax<br>5. Lung haemorrhage<br>6. Diastolic arterial pressure (DAP)<br>7. Necrotising enterocolitis (NEC)<br>8. Chronic lung disease (CLD) or bronchopulmonary dysplasia (BPD)<br>9. Intraventricular hemorrhage (IVH)<br>10. Periventricular leukomalacia (PVL)<br>11. Retinopathy of prematurity (ROP)<br>12. Duration of oxygen treatment (days)<br>13. Duration of nasal CPAP (days)<br>14. Duration of mechanical ventilation (days)