Respiratory Distress Syndrome
Conditions
Interventions
The administration of propofol (1 mg/kg) versus no sedation. In both groups
standard comfort care will be given, which consists of administering sucrose
24% in the cheek pouch of the infant together
Sponsors
Neonatologie
Eligibility
Age
2 Years to 11 Years
Inclusion criteria
Inclusion criteria: Preterm infants (26-37 weeks of gestation) needing surfactant therapy for RDS according to local criteria (FiO2 > 30% and PEEP > 8).
Exclusion criteria
Exclusion criteria: Imminent need for intubation because of respiratory distress, apnea or persistent acidosis. Infants who suffer from pneumothorax or pulmonary hemorrhage.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter is the comfort-neo score, the primary endpoint is the percentage of infants with a comfort-neo score below 14 during the procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameters are; - Occurrence of positive pressure ventilation during and right after the procedure; - Occurrence of intubation needed during the procedure and within 24 hours; - Number of attempts of endotracheal insertion of angiocatheter; - Duration of the total procedure (from start inserting laryngoscope, until exit angiocatheter); - Complications occurring during the procedure: desaturation | — |
Countries
Netherlands
Outcome results
None listed