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Completed

NCT Number: NCT04944108

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

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.

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Key information

Conditions

Respiratory Distress Syndrome Female Urogenital Diseases and Pregnancy Complications Lung Diseases Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Preterm Birth Pulmonary Atelectasis Respiration Disorders Respiratory Tract Diseases Surfactant Deficiency Syndrome Neonatal Urogenital Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Poliambulanza Breacia, Brescia, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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)

Other names: INSURE approach

Insure approach

Procedure

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

Primary outcomes

  1. Time of device positioning

    Time frame: 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 outcomes

  1. Success of the procedure at the first attempt

    Time frame: 1 minute

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

  2. Participant's satisfaction

    Time frame: 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

    Time frame: 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

    Time frame: 10 minutes

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

Sponsors and collaborators

Lead sponsor

University Hospital Padova

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 29, 2021
Registry last updated
Jan 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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