Clinical trial NCT04820101: Dexmedetomidine for LISA Procedure in Preterm Infants
Official title: Dexmedetomidine for LISA Procedure in Preterm Infants: a Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: RDS
Keywords: RDS
LISA
preterm
sedation
dexmedetomidine
Lead sponsor: University of Padova
Sponsor class: OTHER
First posted: 2021-03-29
Enrollment: 40
Sex: ALL
Minimum age (years): 26
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria:

1. Preterm newborns between 26+0 and 36+6 weeks of gestation stratified in two groups: VLBWI 26-31+6and LBWI 32-36+6.
2. Respiratory distress syndrome requiring surfactant therapy

Exclusion Criteria:

1. Need for emergency intubation in the delivery room
2. Major congenital malformations (such as cardiopathies)
3. Chromosomic abnormalities
4. Fetal Hydrops
5. Hypercapnia: CO2 \> 65 mmHg
6. Pneumothorax
7. Hemodynamic compromise

Primary outcomes:
measure: effectiveness of dexmedetomidine in achieving sedation for LISA procedure
timeFrame: basal (before procedure), during and immediately after the procedure
measure: Safety of dexmedetomidine in sedating preterm infants
timeFrame: 24 hours
Secondary outcomes:
measure: number of laryngoscopies needed to perform LISA
timeFrame: during the procedure
measure: time needed to perform LISA
timeFrame: during the procedure
measure: Intubation conditions
timeFrame: during the procedure
measure: the evolution of cardiorespiratory parameters
timeFrame: 1 min, 3 min, 5 min, 15 min, 30 min, 60 min and 120 min after the first drug injection
measure: the evolution of cardiorespiratory parameters
timeFrame: 1 min, 3 min, 5 min, 15 min, 30 min, 60 min and 120 min after the first drug injection
measure: the evolution of cardiorespiratory parameters
timeFrame: 1 min, 3 min, 5 min, 15 min, 30 min, 60 min and 120 min after the first drug injection
measure: the evolution of cardiorespiratory parameters
timeFrame: 1 min, 3 min, 5 min, 15 min, 30 min, 60 min and 120 min after the first drug injection
measure: the evolution of cardiorespiratory parameters
timeFrame: 1 min, 3 min, 5 min, 15 min, 30 min, 60 min and 120 min after the first drug injection
measure: changes in ventilation mode
timeFrame: 1 min, 3 min, 5 min, 15 min, 30 min, 60 min and 120 min after the first drug injection
measure: The incidence of drug adverse effects
timeFrame: 24 hours after drug injection
measure: The incidence of pneumothorax or selective administration of surfactant
timeFrame: 24 hours after drug injection
measure: Long term outcomes
timeFrame: at 40 weeks PMA
measure: Long term outcomes
timeFrame: at 40 weeks PMA
measure: Long term outcomes
timeFrame: at 40 weeks PMA
measure: Long term outcomes
timeFrame: at 40 weeks PMA
measure: Long term outcomes
timeFrame: at 40 weeks PMA
Other outcomes:
Locations:
city: Treviso
country: Italy
facility: Paola Lago
Study officials:
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