RDS
Conditions
Keywords
RDS, LISA, preterm, sedation, dexmedetomidine
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.
Interventions
DRUGDexmedetomidine
administrating dexmedetomidine in order to evaluate the efficacy in achieving sedation for LISA procedure
Sponsors
University of Padova
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
26 Weeks to 36 Weeks
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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 | heart rate (beats per minute) |
| 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) |
| 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 | mortality (%) |
| The incidence of drug adverse effects | 24 hours after drug injection | respiratory events (i.e. bronchospasm) or cardiovascular events (bradycardia, hypotension) |
| time needed to perform LISA | during the procedure | calculate the time needed to perform LISA |
Countries
Italy
Contacts
Primary ContactPaola Lago, MD
Backup ContactBeatrice Galeazzo, MD
Outcome results
None listed