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

Does LISA Change the Time of Device Positioning Compared to INSURE in Extremely Low Birth Weight Infants With RDS? A Crossover Randomized Controlled Manikin Trial

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 Overview

• Status: Completed
• Conditions: Preterm Birth; Respiratory Distress Syndrome; Surfactant Deficiency Syndrome Neonatal
• Intervention / Treatment: Procedure: LISA approach; Procedure: Insure approach

Detailed 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 Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Brescia, Italy
    • Poliambulanza Breacia
  • Padova, Italy, 35128
    • University Hospital of Padova

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Procedure: 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); Other Names: INSURE approach
Active Comparator: Surfactant administration with intubation (INSURE) approach; Participants will be randomized to administer surfactant in a preterm manikin by using the INSURE approach (tracheal tube)	Procedure: Insure approach; Participants will be randomized to administer surfactant in a preterm manikin by using the INSURE approach (tracheal tube)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of device positioning	Time needed for the correct positioning of the device into the trachea (thin catheter or tracheal tube). In case of failure, total time will be the sum of time of all attempts.	10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success of the procedure at the first attempt	It refers at the success of the device positioning during the first attempt	1 minute
Participant's satisfaction	At the end of the procedure, all participants will be required to fill a 5-item questionnaire aimed to assess their perception on the procedure (Likert scale)	5 minutes
Number of attempts to insert the device in the trachea	It refers to the number of attempts to insert the device in the trachea	10 minutes
Correct depth of the device in the trachea	It refers to reaching the correct depth in the trachea as assessed by the external observer using a laryngoscope	10 minutes

Collaborators and Investigators

• Sponsor: University Hospital Padova

Publications and helpful links

General Publications

• Cavallin F, Bua B, Pasta E, Savio F, Villani PE, Trevisanuto D. Device positioning with LISA vs. INSURE: a crossover randomized controlled manikin trial. J Matern Fetal Neonatal Med. 2022 Oct 19:1-7. doi: 10.1080/14767058.2022.2134774. [Epub ahead of print]

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2021
• Primary Completion (Actual): January 14, 2022
• Study Completion (Actual): January 14, 2022

Study Registration Dates

• First Submitted: June 21, 2021
• First Submitted That Met QC Criteria: June 21, 2021
• First Posted (Actual): June 29, 2021

Study Record Updates

• Last Update Posted (Actual): January 18, 2022
• Last Update Submitted That Met QC Criteria: January 14, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease; Infant, Newborn, Diseases; Body Weight; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Infant, Premature, Diseases; Syndrome; Premature Birth; Birth Weight; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
• Other Study ID Numbers: NEOUNIPD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No