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

NCT04944108 | Completed

• 1 other identifier: NEOUNIPD
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Respiratory Distress Syndrome; Preterm Birth; Surfactant Deficiency Syndrome Neonatal

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Success of the procedure at the first attempt

  1 minute

• Participant's satisfaction

  5 minutes

• Number of attempts to insert the device in the trachea

  10 minutes

• Correct depth of the device in the trachea

  10 minutes

Study Arms (2)

Surfactant administration with less invasive surfactant administration (LISA) approach

EXPERIMENTAL

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

Procedure: LISA approach

Surfactant administration with intubation (INSURE) approach

ACTIVE COMPARATOR

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

Procedure: Insure approach

Interventions

LISA approach 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)

Also known as: INSURE approach

Surfactant administration with less invasive surfactant administration (LISA) approach

Insure approach PROCEDURE

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

Surfactant administration with intubation (INSURE) approach

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• University Hospital Padova: lead

Study Sites (2)

Poliambulanza Breacia

Brescia, Italy

Location

University Hospital of Padova

Padua, 35128, Italy

Location

Related Publications (1)

• 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 Dec;35(26):10577-10583. doi: 10.1080/14767058.2022.2134774. Epub 2022 Oct 19.

  PMID: 36261132 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome; Premature Birth; Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 21, 2021
• First Posted: June 29, 2021
• Study Start: December 16, 2021
• Primary Completion: January 14, 2022
• Study Completion: January 14, 2022
• Last Updated: January 18, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)