EUCTR2018-002383-38-FI
Active, not recruiting
Phase 1
Premedication for less invasive surfactant administration - LISA-Med
niversity of Oulu0 sites40 target enrollmentOctober 9, 2018
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversity of Oulu
- Enrollment
- 40
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Gestational age at birth \=26 weeks; respiratory insufficiency managed with non\-invasive respiratory support (nasal CPAP or high\-flow); requirement for oxygen to maintain oxygen saturation (SpO2\) in the target range and need for surfactant treatment (according to clinician’s assessment); if further doses of surfactant are needed, patient can be re\-randomized
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 40
- •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
- •Severe RDS with high oxygen requirements, severe respiratory acidosis and/or widespread atelectasis radiologically, such that ongoing ventilator support will be necessary after surfactant therapy; maxillo\-facial, tracheal or known pulmonary malformations; any known chromosomal abnormality or severe malformation; an alternative cause for respiratory distress (e.g. congenital pneumonia or pulmonary hypoplasia)
Outcomes
Primary Outcomes
Not specified
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