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

Not Applicable

Completed

• Conditions: Respiratory Distress Syndrome; Preterm Birth; Surfactant Deficiency Syndrome Neonatal
• Interventions: Procedure: LISA approach; Procedure: Insure approach

• Registration Number: NCT04944108
• Lead Sponsor: University Hospital Padova

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.

Study Timeline

• Study First Submitted: 2021-06-21
• Study First Submitted QC: 2021-06-21
• Study First Posted: 2021-06-29
• Study Start: 2021-12-16
• Status Verified: 2022-01
• Primary Completion: 2022-01-14
• Study Completion: 2022-01-14
• Last Update Submitted: 2022-01-14
• Last Update Posted: 2022-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

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

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Exclusion Criteria

• There are no exclusion criteria for this study.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surfactant administration with less invasive surfactant administration (LISA) approach	LISA approach	Participants will be randomized to administer surfactant in a preterm manikin by using the LISA approach (thin catheter)
Surfactant administration with intubation (INSURE) approach	Insure approach	Participants will be randomized to administer surfactant in a preterm manikin by using the INSURE approach (tracheal tube)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Success of the procedure at the first attempt	1 minute	It refers at the success of the device positioning during the first attempt
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)
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
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

Trial Locations

Locations (2)

University Hospital of Padova; 🇮🇹 Padova, Italy

Poliambulanza Breacia; 🇮🇹 Brescia, Italy