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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Birth Weight
Premature Birth
Preterm Birth
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Surfactant Deficiency Syndrome Neonatal
Syndrome

Clinical Trial Details

NCT number	NCT04944108
Study type	Interventional
Source	University Hospital Padova
Contact
Status	Completed
Phase	N/A
Start date	December 16, 2021
Completion date	January 14, 2022

View Details

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