Dexmedetomidine for LISA Procedure in Preterm Infants

Not Applicable

• Conditions: RDS
• Interventions: Drug: Dexmedetomidine

• Registration Number: NCT04820101
• Lead Sponsor: University of Padova

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.

Study Timeline

• Study First Submitted: 2021-03-19
• Study First Submitted QC: 2021-03-25
• Study First Posted: 2021-03-29
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-27
• Last Update Posted: 2021-04-29
• Study Start: 2021-05-15
• Primary Completion: 2023-04-01
• Study Completion: 2023-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Every preterm newborns 26+0 -36+6 wGA with RDS needing surfactant therapy	Dexmedetomidine	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.

Primary Outcome Measures

Name	Time	Method
effectiveness of dexmedetomidine in achieving sedation for LISA procedure	basal (before procedure), during and immediately after the procedure	evaluation of changes in Neonatal Infant Pain Scale (NIPS) score (0-2 points= no pain, 3-4 points = moderate pain; \> 4 = severe pain)
Safety of dexmedetomidine in sedating preterm infants	24 hours	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.

Secondary Outcome Measures

Name	Time	Method
Intubation conditions	during the procedure	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)
number of laryngoscopies needed to perform LISA	during the procedure	calculate the number of laryngoscopies needed to perform LISA
The incidence of pneumothorax or selective administration of surfactant	24 hours after drug injection	RX evaluation
Long term outcomes	at 40 weeks PMA	retinopathy of prematurity (%)
time needed to perform LISA	during the procedure	calculate the time needed to perform LISA
changes in ventilation mode	1 min, 3 min, 5 min, 15 min, 30 min, 60 min and 120 min after the first drug injection	inspiratory and end-expiratory ventilation pressures changes (cmH2O)
the evolution of cardiorespiratory parameters	1 min, 3 min, 5 min, 15 min, 30 min, 60 min and 120 min after the first drug injection	FiO2 maxima during the procedure maintained for at least 30 seconds (%)
The incidence of drug adverse effects	24 hours after drug injection	respiratory events (i.e. bronchospasm) or cardiovascular events (bradycardia, hypotension)

Trial Locations

Locations (1)

Paola Lago; 🇮🇹 Treviso, Italy