Respiratory Distress Syndrome (RDS) in infants 24-29 weeks`gestation
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. GA 24 + 0 to 29 + 9 wk 2. Early nasal CPAP 3. Gastric aspirate not later than 45 min after birth 4. Informed consent (written and orally) before birth or lates 1 h after birth Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Prolonged rupture of the membranes > 3 wk 2. Therapeutic infusions in the amniotic cave 3. Lethal malformations 4. Intubation in the delivery room before randomisation 5. Meconium or pus contamination of the gastric aspirate 6. The neonatal ward too busy with other patients 7. No gastric aspirate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To better the outcome of RDS including survival and survival without sequelae by very early selective treatment of infants on nasal CPAP with Curosurf.;Secondary Objective: ;Primary end point(s): Mechanical ventilation or death within the first 5 days of life | — |
Countries
Denmark, Sweden