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

Sponsor
University Hospital Padova (Other)
Overall Status
Completed
CT.gov ID
NCT04944108
Collaborator
(none)
42
Enrollment
2
Locations
2
Arms
29
Actual Duration (Days)
21
Patients Per Site
22
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: LISA approach
  • Procedure: Insure approach
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
42 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Dec 16, 2021
Actual Primary Completion Date :
Jan 14, 2022
Actual Study Completion Date :
Jan 14, 2022

Arms and Interventions

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)

    Outcome Measures

    Primary Outcome Measures

    1. Time of device positioning [10 minutes]

      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.

    Secondary Outcome Measures

    1. Success of the procedure at the first attempt [1 minute]

      It refers at the success of the device positioning during the first attempt

    2. Participant's satisfaction [5 minutes]

      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)

    3. Number of attempts to insert the device in the trachea [10 minutes]

      It refers to the number of attempts to insert the device in the trachea

    4. Correct depth of the device in the trachea [10 minutes]

      It refers to reaching the correct depth in the trachea as assessed by the external observer using a laryngoscope

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Poliambulanza Breacia Brescia Italy
    2 University Hospital of Padova Padova Italy 35128

    Sponsors and Collaborators

    • University Hospital Padova

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Daniele Trevisanuto, Associate Professor, University Hospital Padova
    ClinicalTrials.gov Identifier:
    NCT04944108
    Other Study ID Numbers:
    • NEOUNIPD
    First Posted:
    Jun 29, 2021
    Last Update Posted:
    Jan 18, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Respiratory Distress Syndrome
    Respiratory Distress Syndrome, Newborn
    Premature Birth
    Syndrome
    Birth Weight

    Study Results

    No Results Posted as of Jan 18, 2022