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

University Hospital Padova

Status: Completed

Conditions: Respiratory Distress Syndrome, Newborn

Treatments: Device: Surfactant administration with less invasive surfactant administration (LISA) marked tip catheter; Device: Surfactant administration with less invasive surfactant administration (LISA) unmarked tip catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT05399628

NEOUNIPD2(2022)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Refusal to participate in the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Surfactant administration with less invasive surfactant administration (LISA) marked tip catheter

Experimental group

Description:

Participants will be assigned to perform the procedure with a LISA catheter with a marked tip

Treatment:

Device: Surfactant administration with less invasive surfactant administration (LISA) marked tip catheter

Surfactant administration with less invasive surfactant administration (LISA) unmarked tip catheter

Active Comparator group

Description:

Participants will be assigned to perform the procedure with a LISA catheter with an unmarked tip

Treatment:

Device: Surfactant administration with less invasive surfactant administration (LISA) unmarked tip catheter