Dexmedetomidine for LISA Procedure in Preterm Infants (DEXLISA)

University of Padova

Status: Unknown

Conditions: RDS

Treatments: Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT04820101

DEXLISA 920/CE Marca

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 26 to 36 weeks old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Every preterm newborns 26+0 -36+6 wGA with RDS needing surfactant therapy

Experimental group

Description:

Every preterm newborns 26+0-36+6 wGA who undergoes LISA procedure will receive sedation with dexmedetomidine in order to evaluate its efficacy in achieving pain control and comfort.

Treatment:

Drug: Dexmedetomidine