NCT06878703View on ClinicalTrials.gov

Efficacy of Dexmedetomidine Versus Midazolam Sedation on Extubation Time in Mechanically Ventilated Preterm Infants

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

380

Participants

Timeline

Start Date

September 15, 2025

Primary Completion Date

November 6, 2027

Study Completion Date

December 15, 2029

Conditions
PreTerm NeonateSedation for Invasive Mechanical VentilationVery Preterm Neonates With Sedation for Invasive Mechanical Ventilation
Interventions
DRUG

Midazolam

Continuous intravenous administration with a loading dose of 10 µg/kg over 30 min, followed by a maintenance dose (from 10 to 40 µg/kg/h)

DRUG

Dexmedetomidine

Continuous intravenous administration with a loading dose of 0.05 μg/kg over 30 minutes followed by a maintenance dose (from 0.05 to 0.2 μg/kg/h)

Trial Locations (1)

75012

Hospital Armand Trousseau, APHP Service : Department of Neonatology, Paris

All Listed Sponsors
collaborator

Dr DATA

UNKNOWN

lead

Assistance Publique - Hôpitaux de Paris

OTHER