Back to resultsLISA vs INSURE in Extremely Low Birth Weight Infants. A Manikin Study
Primary Purpose
Respiratory Distress Syndrome, Preterm Birth, Surfactant Deficiency Syndrome Neonatal
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
LISA approach
Insure approach
Sponsored by
About this trial
This is an interventional treatment trial for Respiratory Distress Syndrome
Eligibility Criteria
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.
Sites / Locations
- Poliambulanza Breacia
- University Hospital of Padova
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Surfactant administration with less invasive surfactant administration (LISA) approach
Surfactant administration with intubation (INSURE) approach
Arm Description
Participants will be randomized to administer surfactant in a preterm manikin by using the LISA approach (thin catheter)
Participants will be randomized to administer surfactant in a preterm manikin by using the INSURE approach (tracheal tube)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Success of the procedure at the first attempt
It refers at the success of the device positioning during the first attempt
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)
Number of attempts to insert the device in the trachea
It refers to the number of attempts to insert the device in the trachea
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
Full Information
NCT ID
NCT04944108
First Posted
June 21, 2021
Last Updated
January 14, 2022
Sponsor
University Hospital Padova
1. Study Identification
Unique Protocol Identification Number
NCT04944108
Brief Title
LISA vs INSURE in Extremely Low Birth Weight Infants. A Manikin Study
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
December 16, 2021 (Actual)
Primary Completion Date
January 14, 2022 (Actual)
Study Completion Date
January 14, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Padova
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome, Preterm Birth, Surfactant Deficiency Syndrome Neonatal
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Surfactant administration with less invasive surfactant administration (LISA) approach
Arm Type
Experimental
Arm Description
Participants will be randomized to administer surfactant in a preterm manikin by using the LISA approach (thin catheter)
Arm Title
Surfactant administration with intubation (INSURE) approach
Arm Type
Active Comparator
Arm Description
Participants will be randomized to administer surfactant in a preterm manikin by using the INSURE approach (tracheal tube)
Intervention Type
Procedure
Intervention Name(s)
LISA approach
Other Intervention Name(s)
INSURE approach
Intervention Description
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
Intervention Name(s)
Insure approach
Intervention Description
Participants will be randomized to administer surfactant in a preterm manikin by using the INSURE approach (tracheal tube)
Primary Outcome Measure Information:
Title
Time of device positioning
Description
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.
Time Frame
10 minutes
Secondary Outcome Measure Information:
Title
Success of the procedure at the first attempt
Description
It refers at the success of the device positioning during the first attempt
Time Frame
1 minute
Title
Participant's satisfaction
Description
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)
Time Frame
5 minutes
Title
Number of attempts to insert the device in the trachea
Description
It refers to the number of attempts to insert the device in the trachea
Time Frame
10 minutes
Title
Correct depth of the device in the trachea
Description
It refers to reaching the correct depth in the trachea as assessed by the external observer using a laryngoscope
Time Frame
10 minutes
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Poliambulanza Breacia
City
Brescia
Country
Italy
Facility Name
University Hospital of Padova
City
Padova
ZIP/Postal Code
35128
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
36261132
Citation
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.
Results Reference
derived
Learn more about this trial
LISA vs INSURE in Extremely Low Birth Weight Infants. A Manikin Study
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