RDS surfactant non-invasive
Conditions
Interventions
The investigational treatment is the use of sedation during the MIST procedure. Hereby propofol will be used, which is standardly used in our NICU for intubation. The risk for side effects will be mi
Sponsors
Leiden University Medical Centre
Eligibility
Inclusion criteria
Inclusion criteria: Preterm infants (26-37 weeks of gestation) needing surfactant therapy for RDS according to the local criteria (FiO2 >30% and PEEP ¡Ý 8) can be randomized for sedation or no sedation.
Exclusion criteria
Exclusion criteria: Excluded are infants where there is imminent need of intubation because of respiratory distress, apnoea or persistent acidosis. Infants who suffer from a pneumothorax or pulmonary haemorrhage will also be excluded.
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 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 < 85%, hypotension (mean below gestational age), bradycardia < 80 bpm, nasal haemorrhage Other complications: pneumothorax, pulmonary haemorrhage, resuscitation Heart rate and blood pressure before, during and 5 minutes after the procedure. | — |
Contacts
Public ContactJanneke Dekker
LUMC
Outcome results
None listed