Assesment of Propofol sedation during intra tracheal surfactant administration by the LISA method (Less Invasive Surfactant Administration)

Phase 1

• Conditions: Respiratory Distress Syndrome of preterm babies born < 32 weeks of gestational age; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2018-002876-41-FR
• Lead Sponsor: CHU Grenoble-Alpes

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-08-08
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: A
• Sex: Not specified
• Target Recruitment: 542

Inclusion Criteria

- Preterm Infants < 32 wGA
- Presenting a RDS
in the first 48 hours of life
treated by CPAP
requiring surfactant :
FIO2 :
if 28 - 31 SA : FiO2 =30% for a duration = 10mn
if <28 SA FIO2 =25% for a duration =10mn
SaO2 :
To obtain a SaO2 between =88 and = 95%

- Available Intra-Venous line
- Covered by French Social Security
- Informed consent form signed

Are the trial subjects under 18? yes
Number of subjects for this age range: 542
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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified