NCT04820101

Dexmedetomidine for LISA Procedure in Preterm Infants

Dexmedetomidine for LISA Procedure in Preterm Infants: a Pilot Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of Padova · Academic / Other
• Sex: All
• Age: 26 Weeks – 36 Weeks
• Healthy volunteers: Accepted

Summary

The investigators aim to evaluate: the effectiveness of dexmedetomidine for analgesia and sedation during LISA procedure, without compromising the respiratory drive; the safety of this drug on the preterm infant in a pilot study.

Detailed description

Information will be given to parents of preterm babies \<36 wGA upon their admission to the NICU (neonatal intensive care unit), and informed consent will be obtained as soon as possible. Eligible babies for LISA procedure (dyspneic and FiO2 \> 0.30 on CPAP pressure of at least 6 cmH2O) undergo sedation with dexmedetomidine 1 mcg/kg, administered slowly iv in 10 minutes, together with non pharmacological techniques. After the step of sedation LISA is performed. Before/during and after the procedure pain will be assessed by the NIPS scale and the quality of intubation will be evaluated; then other events related to the procedure will be strictly collected for the first 24 hours. Babies will then be managed in usual NICU way and clinical data will be unregistered on respiratory, neurological and hemodynamic outcomes during the hospital stay, and especially at discharge.

Conditions

• RDS

Interventions

Type	Name	Description
DRUG	Dexmedetomidine	administrating dexmedetomidine in order to evaluate the efficacy in achieving sedation for LISA procedure

Timeline

• Start date: 2021-05-15
• Primary completion: 2023-04-01
• Completion: 2023-04-01
• First posted: 2021-03-29
• Last updated: 2021-04-29

Locations

1 site across 1 country: Italy