Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04820101
Study type Interventional
Source University of Padova
Contact Paola Lago, MD
Phone 00390422322608
Email paola.lago@aulss2.veneto.it
Status Not yet recruiting
Phase N/A
Start date May 15, 2021
Completion date April 1, 2023

See also
  Status Clinical Trial Phase
Completed NCT01517958 - Lung Ultrasound to Diagnose Transient Tachypnea of the Newborn (TTN) Versus Respiratory Distress Syndrome (RDS) in Neonates N/A
Not yet recruiting NCT02571231 - High Flow Ventilation With Volume Guarantee N/A
Completed NCT02076126 - Determination of Lung Maturity and Prediction of RDS at Birth N/A
Not yet recruiting NCT01265589 - Intratracheal Vitamin A Administration With Surfactant for Newborn Respiratory Distress Syndrome Phase 3
Completed NCT01511952 - A Multi-Site Study of Music Therapy Interventions on Vitals, Feeding and Sleep in Premature Infants N/A
Recruiting NCT05493527 - Noninvasive High Frequency Oscillatory Ventilation as a Post-extubation Respiratory Support in Neonates N/A
Completed NCT03008200 - Fetal Pulmonary Artery Acceleration to Ejection Time Ratio (PATET) in the Prediction of Subsequent Development of Respiratory Distress Syndrome (RDS) N/A
Completed NCT01942473 - Effects of Automated Adjustment of FiO2 on Cerebral and Arterial Oxygenation in Preterm Infants N/A
Recruiting NCT03217162 - Surfactant for Neonate With Acute Respiratory Distress Syndrome (ARDS) N/A