Dexmedetomidine for LISA Procedure in Preterm Infants

Study Overview
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Brief Summary
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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
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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.

Official Title
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Dexmedetomidine for LISA Procedure in Preterm Infants: a Pilot Study

Conditions
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RDS

Intervention / Treatment
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* Drug: Dexmedetomidine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 26 Weeks
Maximum Age: 36 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Every preterm newborns 26+0 -36+6 wGA with RDS needing surfactant therapy<br>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. | Drug: Dexmedetomidine<br>* administrating dexmedetomidine in order to evaluate the efficacy in achieving sedation for LISA procedure<br>* Other names: LISA procedure;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effectiveness of dexmedetomidine in achieving sedation for LISA procedure | evaluation of changes in Neonatal Infant Pain Scale (NIPS) score (0-2 points= no pain, 3-4 points = moderate pain; > 4 = severe pain) | basal (before procedure), during and immediately after the procedure | 
| Safety of dexmedetomidine in sedating preterm infants | evaluation of number of apneas ( > 20 seconds or < 20 seconds with bradycardia < 100 bpm or desaturation ( SpO2 < 85%)); number of severe apnea and bradycardia (defined by the American Academy of Pediatrics Guidelines as apnea > 30 seconds and/or heart rate < 60 beats/minute for more than 10 seconds); need for intubation. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of laryngoscopies needed to perform LISA | calculate the number of laryngoscopies needed to perform LISA | during the procedure | 
| time needed to perform LISA | calculate the time needed to perform LISA | during the procedure | 
| Intubation conditions | evaluated by the operator using the Goldberg scale (3 = excellent intubation conditions; 4-6= good intubation conditions; 7-9 = poor intubation conditions; 10-12 = inadequate intubation conditions) | during the procedure | 
| the evolution of cardiorespiratory parameters | heart rate (beats per minute) | 1 min, 3 min, 5 min, 15 min, 30 min, 60 min and 120 min after the first drug injection | 
| the evolution of cardiorespiratory parameters | respiratory rate (breaths per minute) | 1 min, 3 min, 5 min, 15 min, 30 min, 60 min and 120 min after the first drug injection | 
| the evolution of cardiorespiratory parameters | pulse oximetry (%) | 1 min, 3 min, 5 min, 15 min, 30 min, 60 min and 120 min after the first drug injection | 
| the evolution of cardiorespiratory parameters | blood pressure (mmHg) | 1 min, 3 min, 5 min, 15 min, 30 min, 60 min and 120 min after the first drug injection | 
| the evolution of cardiorespiratory parameters | FiO2 maxima during the procedure maintained for at least 30 seconds (%) | 1 min, 3 min, 5 min, 15 min, 30 min, 60 min and 120 min after the first drug injection | 
| changes in ventilation mode | inspiratory and end-expiratory ventilation pressures changes (cmH2O) | 1 min, 3 min, 5 min, 15 min, 30 min, 60 min and 120 min after the first drug injection | 
| The incidence of drug adverse effects | respiratory events (i.e. bronchospasm) or cardiovascular events (bradycardia, hypotension) | 24 hours after drug injection | 
| The incidence of pneumothorax or selective administration of surfactant | RX evaluation | 24 hours after drug injection | 
| Long term outcomes | mortality (%) | at 40 weeks PMA | 
| Long term outcomes | bronchopulmonary dysplasia (%), defined as oxygen administration and/or respiratory support at 36 wGA | at 40 weeks PMA | 
| Long term outcomes | intraventricular hemorrhage (%) and periventricular leukomalacia (%) | at 40 weeks PMA | 
| Long term outcomes | necrotizing enterocolitis (%) | at 40 weeks PMA | 
| Long term outcomes | retinopathy of prematurity (%) | at 40 weeks PMA | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RDS, LISA, preterm, sedation, dexmedetomidine