NCT04944108

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: University Hospital Padova · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Respiratory Distress Syndrome
• Preterm Birth
• Surfactant Deficiency Syndrome Neonatal

Interventions

Type	Name	Description
PROCEDURE	LISA approach	Participants will be randomized to administer surfactant in a preterm manikin by using the LISA approach (thin catheter) or the INSURE approach (tracheal tube)
PROCEDURE	Insure approach	Participants will be randomized to administer surfactant in a preterm manikin by using the INSURE approach (tracheal tube)

Timeline

• Start date: 2021-12-16
• Primary completion: 2022-01-14
• Completion: 2022-01-14
• First posted: 2021-06-29
• Last updated: 2022-01-18

Locations

2 sites across 1 country: Italy