EUCTR2018-002876-41-FR
Active, not recruiting
Phase 1
Assesment of Propofol sedation during intra tracheal surfactant administration by the LISA method (Less Invasive Surfactant Administration) - PROLISA
CHU Grenoble-Alpes0 sites542 target enrollmentAugust 8, 2018
DrugsPROPOFOL LIPURO 1%
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- CHU Grenoble-Alpes
- Enrollment
- 542
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Preterm Infants \< 32 wGA
- •\- Presenting a RDS
- •in the first 48 hours of life
- •treated by CPAP
- •requiring surfactant :
- •if 28 \- 31 SA : FiO2 \=30% for a duration \= 10mn
- •if \<28 SA FIO2 \=25% for a duration \=10mn
- •To obtain a SaO2 between \=88 and \= 95%
- •\- Available Intra\-Venous line
- •\- Covered by French Social Security
Exclusion Criteria
- •\- Congenital and/or major malformations
- •\- FIO2\> 60%
- •\- Silverman score\> at 6
- •\- Low Blood Pressure with 2 successive measurements (Mean \< Gestational Age expressed in Weeks of Gestation) persisting after one volume expansion
- •\- Use of inotropic medication to maintain normal blood pressure.
- •\- Use of sedative or analgesic drugs (except paracetamol and ibuprofen) in the previous 24h
Outcomes
Primary Outcomes
Not specified
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