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

Preterm Birth Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04944108
• Other study ID #: NEOUNIPD
• Status: Completed
• Phase: N/A
• Start date: December 16, 2021
• Est. completion date: January 14, 2022

Study information

• Verified date: January 2022
• Source: University Hospital Padova
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: January 14, 2022
• Est. primary completion date: January 14, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Italy	Poliambulanza Breacia	Brescia
Italy	University Hospital of Padova	Padova

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Padova

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Success of the procedure at the first attempt	It refers at the success of the device positioning during the first attempt	1 minute
Secondary	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
Secondary	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
Secondary	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