NCT05399628

LISA Catheter With Marked vs. Unmarked Tip in Extremely Low Birth Weight Infants With RDS

LISA Catheter With Marked vs. Unmarked Tip in Extremely Low Birth Weight Infants With RDS: a Crossover Randomized Controlled Manikin Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (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 catheter with a marked tip vs. LISA catheter with an unmarked tip 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 positioning of the device at the correct depth in the trachea. The secondary outcome measures will be the time and number of attempts to achieve the correct depth and participant satisfaction.

Detailed description

Although less invasive surfactant administration (LISA) offers some advantages in ventilation procedure and neonatal outcomes, achieving the correct depth in the trachea using a LISA catheter may be difficult. This may have some drawbacks such as impaired surfactant administration (reducing the efficacy of the procedure) or prolonged duration of the laryngoscopy (aggravating the invasiveness of the procedure). The aims of the present study should be: i) positioning of the device at the correct depth in the trachea, ii) time and number of attempts to achieve the correct depth, iii) participant satisfaction. This is an unblinded, randomized, controlled, crossover (AB/BA) trial of surfactant treatment with LISA catheter with a marked tip vs. LISA catheter with an unmarked tip 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 positioning of the device at the correct depth in the trachea. The secondary outcome measures will be the time and number of attempts to achieve the correct depth and participant satisfaction.

Conditions

• Respiratory Distress Syndrome, Newborn

Interventions

Type	Name	Description
DEVICE	Surfactant administration with less invasive surfactant administration (LISA) marked tip catheter	Participants will be assigned to perform the procedure with LISA catheter with a marked tip
DEVICE	Surfactant administration with less invasive surfactant administration (LISA) unmarked tip catheter	Participants will be assigned to perform the procedure with LISA catheter with an unmarked tip

Timeline

• Start date: 2022-06-06
• Primary completion: 2022-06-11
• Completion: 2022-06-11
• First posted: 2022-06-01
• Last updated: 2022-07-26

Locations

1 site across 1 country: Italy