Clinical trial NCT04944108: LISA vs INSURE in Extremely Low Birth Weight Infants. A Manikin Study
Official title: Does LISA Change the Time of Device Positioning Compared to INSURE in Extremely Low Birth Weight Infants With RDS? A Crossover Randomized Controlled Manikin Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Distress Syndrome
Preterm Birth
Surfactant Deficiency Syndrome Neonatal
Lead sponsor: University Hospital Padova
Sponsor class: OTHER
First posted: 2021-06-29
Enrollment: 42
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an unblinded, randomized, controlled, crossover (AB/BA) trial of surfactant treatment with LISA vs. INSURE in a manikin simulating an extremely low birth weight infant. Participants will be level III NICU consultants and residents. Randomization will be performed using a computer-generated random assignment list. The primary outcome measure will be the total time of device positioning. The secondary outcomes will be the success of the first and the participant's satisfaction.

Detailed description: Background: Although LISA offers some advantages in ventilation procedure and neonatal outcomes over INSURE, the use of a catheter during LISA may have some drawbacks such as the prolonged duration of the laryngoscopy needed to insert the device. This is likely to aggravate the invasiveness of the procedure, resulting in stressful consequences such as bradycardia, hypoxia and hemodynamic changes.

Objectives: i) time of device positioning, ii) success of the procedure of positioning the device, iii) participant's satisfaction.

Methods: This is an unblinded, randomized, controlled, crossover (AB/BA) trial of surfactant treatment with LISA vs. INSURE in a manikin simulating an extremely low birth weight infant. Participants will be level III NICU consultants and residents. Randomization will be performed using a computer-generated random assignment list. The primary outcome measure will be the total time of device positioning. The secondary outcomes will be the success of the first and the participant's satisfaction.

Eligibility criteria: Inclusion Criteria:

* Level III NICU consultants and residents will be eligible to participate in the study.

Exclusion Criteria:

* There are no exclusion criteria for this study.

Primary outcomes:
measure: Time of device positioning
timeFrame: 10 minutes
Secondary outcomes:
measure: Success of the procedure at the first attempt
timeFrame: 1 minute
measure: Participant's satisfaction
timeFrame: 5 minutes
measure: Number of attempts to insert the device in the trachea
timeFrame: 10 minutes
measure: Correct depth of the device in the trachea
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: Poliambulanza Breacia
city: Padova
country: Italy
facility: University Hospital of Padova
Study officials:
References:
citation: Cavallin F, Bua B, Pasta E, Savio F, Villani PE, Trevisanuto D. Device positioning with LISA vs. INSURE: a crossover randomized controlled manikin trial. J Matern Fetal Neonatal Med. 2022 Dec;35(26):10577-10583. doi: 10.1080/14767058.2022.2134774. Epub 2022 Oct 19.