Status:
UNKNOWN
Dexmedetomidine for LISA Procedure in Preterm Infants
Lead Sponsor:
University of Padova
Conditions:
RDS
Eligibility:
All Genders
26-36 years
Phase:
NA
Brief 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 pre...
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 bab...
Eligibility Criteria
Inclusion
- Preterm newborns between 26+0 and 36+6 weeks of gestation stratified in two groups: VLBWI 26-31+6and LBWI 32-36+6.
- Respiratory distress syndrome requiring surfactant therapy
Exclusion
- Need for emergency intubation in the delivery room
- Major congenital malformations (such as cardiopathies)
- Chromosomic abnormalities
- Fetal Hydrops
- Hypercapnia: CO2 \> 65 mmHg
- Pneumothorax
- Hemodynamic compromise
Key Trial Info
Start Date :
May 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04820101
Start Date
May 15 2021
End Date
April 1 2023
Last Update
April 29 2021
Active Locations (1)
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1
Paola Lago
Treviso, Italy, 31100