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Premedication for Less Invasive Surfactant Administration (LISA-Med)

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-520492-10-00
Enrollment
40
Registered
2025-01-28
Start date
Unknown
Completion date
Unknown
Last updated
2025-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

respiratory distress syndrome, surfactant treatment, premedication

Brief summary

Any adverse event (the need of positive pressure ventilation, intubation, heart rate below 80/min, mean arterial pressure change more than 20%, pH change more than 0.4, CO2 change more than 20%, and saturation <85 for more than 1 minute)

Detailed description

Duration of the procedure, Number of attempts to get the catether intratracheally, Pain score NIAPAS, The need for additional dosing of study drug or midazolam (number of addtional dosages), Edi-signals

Interventions

DRUGFentanyl-hameln 50 Mikrogramm/ml Injektionslösung
DRUGKetanest-S 5 mg/ml injektio-/infuusioneste
DRUGliuos

Sponsors

Pohjois-Pohjanmaan hyvinvointialue, University Of Oulu
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
Any adverse event (the need of positive pressure ventilation, intubation, heart rate below 80/min, mean arterial pressure change more than 20%, pH change more than 0.4, CO2 change more than 20%, and saturation <85 for more than 1 minute)

Secondary

MeasureTime frame
Duration of the procedure, Number of attempts to get the catether intratracheally, Pain score NIAPAS, The need for additional dosing of study drug or midazolam (number of addtional dosages), Edi-signals

Countries

Finland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026