Propofol during Minimal Invasive Surfactant Evaluation Study
Completed
- Conditions
- Respiratory Distress Syndrome1003868610028920
- Registration Number
- NL-OMON40970
- Lead Sponsor
- eonatologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 78
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
Imminent need for intubation because of respiratory distress, apnea or persistent acidosis.
Infants who suffer from pneumothorax or pulmonary hemorrhage.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study parameter is the comfort-neo score, the primary endpoint is the<br /><br>percentage of infants with a comfort-neo score below 14 during the procedure.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary study parameters are;<br /><br>- Occurrence of positive pressure ventilation during and right after the<br /><br>procedure;<br /><br>- Occurrence of intubation needed during the procedure and within 24 hours;<br /><br>- Number of attempts of endotracheal insertion of angiocatheter;<br /><br>- Duration of the total procedure (from start inserting laryngoscope, until<br /><br>exit angiocatheter);<br /><br>- Complications occurring during the procedure: desaturation < 85%, hypotension<br /><br>(mean below gestational age), bradycardia < 80 bpm, nasal hemorrhage;<br /><br>- Other complications: pneumothorax, pulmonary haemorrhage, resuscitation;<br /><br>- Heart rate and blood pressure before, during and 5 minutes after the<br /><br>procedure.</p><br>