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

University Hospital Padova

Status: Completed

Conditions: Respiratory Distress Syndrome; Surfactant Deficiency Syndrome Neonatal; Preterm Birth

Treatments: Procedure: LISA approach; Procedure: Insure approach

Study type: Interventional

Funder types: Other

Identifiers

NCT04944108

NEOUNIPD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 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

• There are no exclusion criteria for this study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

Surfactant administration with less invasive surfactant administration (LISA) approach

Experimental group

Description:

Participants will be randomized to administer surfactant in a preterm manikin by using the LISA approach (thin catheter)

Treatment:

Procedure: LISA approach

Surfactant administration with intubation (INSURE) approach

Active Comparator group

Description:

Participants will be randomized to administer surfactant in a preterm manikin by using the INSURE approach (tracheal tube)

Treatment:

Procedure: Insure approach