LISA vs INSURE in Extremely Low Birth Weight Infants. A Manikin Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Respiratory Distress Syndrome, Preterm Birth, Surfactant Deficiency Syndrome Neonatal

Intervention / Treatment
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* Procedure: LISA approach
* Procedure: Insure approach


Participation Criteria
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Eligibility Criteria
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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.
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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Surfactant administration with less invasive surfactant administration (LISA) approach<br>Participants will be randomized to administer surfactant in a preterm manikin by using the LISA approach (thin catheter) | Procedure: LISA approach<br>* Participants will be randomized to administer surfactant in a preterm manikin by using the LISA approach (thin catheter) or the INSURE approach (tracheal tube)<br>* Other names: INSURE approach;|
| Active Comparator: Surfactant administration with intubation (INSURE) approach<br>Participants will be randomized to administer surfactant in a preterm manikin by using the INSURE approach (tracheal tube) | Procedure: Insure approach<br>* Participants will be randomized to administer surfactant in a preterm manikin by using the INSURE approach (tracheal tube)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of device positioning | Time needed for the correct positioning of the device into the trachea (thin catheter or tracheal tube). In case of failure, total time will be the sum of time of all attempts. | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success of the procedure at the first attempt | It refers at the success of the device positioning during the first attempt | 1 minute | 
| Participant's satisfaction | At the end of the procedure, all participants will be required to fill a 5-item questionnaire aimed to assess their perception on the procedure (Likert scale) | 5 minutes | 
| Number of attempts to insert the device in the trachea | It refers to the number of attempts to insert the device in the trachea | 10 minutes | 
| Correct depth of the device in the trachea | It refers to reaching the correct depth in the trachea as assessed by the external observer using a laryngoscope | 10 minutes |