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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-16

Study Completion Date

2022-01-14

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.

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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.

Conditions

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Respiratory Distress Syndrome Preterm Birth Surfactant Deficiency Syndrome Neonatal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Surfactant administration with less invasive surfactant administration (LISA) approach

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

Group Type EXPERIMENTAL

LISA approach

Intervention Type PROCEDURE

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

Surfactant administration with intubation (INSURE) approach

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

Group Type ACTIVE_COMPARATOR

Insure approach

Intervention Type PROCEDURE

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

Interventions

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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)

Intervention Type PROCEDURE