An interventional study of LISA approach and Insure approach in Respiratory Distress Syndrome, Preterm Birth and Surfactant Deficiency Syndrome Neonatal, sponsored by University Hospital Padova. Completed at 2 sites in Italy. Per ClinicalTrials.gov, last updated 2022-01-18.
Sponsored by University Hospital Padova · Not applicable, Interventional, and Treatment
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.
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.
1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.
This study's enrollment of 42 is below the median of 60 across 961 interventional studies indexed under Respiratory Distress Syndrome.
Browse Respiratory Distress Syndrome studies →University Hospital Padova is the lead sponsor of 41 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 INSURE approach (tracheal tube)
Procedure: Insure 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)
Also known as: INSURE approach
Participants will be randomized to administer surfactant in a preterm manikin by using the INSURE approach (tracheal tube)
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.
Time frame: 10 minutes
Success of the procedure at the first attempt
It refers at the success of the device positioning during the first attempt
Time frame: 1 minute
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)
Time frame: 5 minutes
Number of attempts to insert the device in the trachea
It refers to the number of attempts to insert the device in the trachea
Time frame: 10 minutes
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
Time frame: 10 minutes
Plan to share: No
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Respiratory Distress Syndrome→
University Hospital Padova