Respiratory Distress SyndromeNCT04944108
LISA vs INSURE in Extremely Low Birth Weight Infants. A Manikin Study
A study testing LISA approach and Insure approach in people with Respiratory Distress Syndrome and Preterm Birth, run by University Hospital Padova at 2 sites in Italy.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Respiratory Distress Syndrome, Preterm Birth, Surfactant Deficiency Syndrome Neonatal
- What is being tested?
- LISA approach and Insure approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesItaly
- Study dates
- 16 Dec 2021to 14 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Level III NICU consultants and residents will be eligible to participate in the study.
Who cannot join
- There are no exclusion criteria for this study.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Poliambulanza Breacia
Brescia
University Hospital of Padova
Padova, 35128
About this 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
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.
Read the 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.
- Being tested
- LISA approach, Insure approach
- Medical subject headings
- Respiratory Distress Syndrome, Premature Birth, Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LISA approachProcedure or surgery
Also called 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)
Insure approachProcedure or surgery
Participants will be randomized to administer surfactant in a preterm manikin by using the INSURE approach (tracheal tube)
| Study group | Role | What they receive |
|---|---|---|
| Surfactant administration with less invasive surfactant administration (LISA) approach | Experimental | Participants will be randomized to administer surfactant in a preterm manikin by using the LISA approach (thin catheter) Receives: Procedure: LISA approach |
| Surfactant administration with intubation (INSURE) approach | Active comparator | Participants will be randomized to administer surfactant in a preterm manikin by using the INSURE approach (tracheal tube) Receives: Procedure: Insure approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 minutes
Secondary outcomes (4)
Success of the procedure at the first attempt
It refers at the success of the device positioning during the first attempt
Measured: 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)
Measured: 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
Measured: 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
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study start16 Dec 2021
- Primary completion14 Jan 2022
- Study completion14 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory Distress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniele Trevisanuto, University Hospital Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04944108
- Sponsor's protocol ID
- NEOUNIPD
- Status last verified
- Jan 2022
- First submitted
- 21 Jun 2021
- Last updated
- 18 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36261132
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04944108
- Acronym / sponsor ID
- NEOUNIPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University Hospital PadovaUniversity, hospital or other
- Study start
- 16 Dec 2021 (actual)
- Primary completion
- 14 Jan 2022 (actual)
- Study completion
- 14 Jan 2022 (actual)
- First posted
- 29 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surfactant administration with less invasive surfactant administration (LISA) approach | Experimental | Procedure: LISA approachParticipants will be randomized to administer surfactant in a preterm manikin by using the LISA approach (thin catheter) |
| Surfactant administration with intubation (INSURE) approach | Active comparator | Procedure: Insure approachParticipants will be randomized to administer surfactant in a preterm manikin by using the INSURE approach (tracheal tube) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Level III NICU consultants and residents will be eligible to participate in the study.
Key exclusion criteria (1 listed)
- There are no exclusion criteria for this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LISA approachAlso: INSURE approachParticipants will be randomized to administer surfactant in a preterm manikin by using the LISA approach (thin catheter) or the INSURE approach (tracheal tube) | Procedure or surgery | Surfactant administration with less invasive surfactant administration (LISA) approach |
| Insure approachParticipants will be randomized to administer surfactant in a preterm manikin by using the INSURE approach (tracheal tube) | Procedure or surgery | Surfactant administration with intubation (INSURE) approach |
Primary outcome
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.
4 secondary outcomes
Success of the procedure at the first attempt
Time frame: 1 minute
Participant's satisfaction
Time frame: 5 minutes
Number of attempts to insert the device in the trachea
Time frame: 10 minutes
Correct depth of the device in the trachea
Time frame: 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2022.
- Derived from this study: PubMed 36261132Cavallin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LISA approach and Insure approach in people with Respiratory Distress Syndrome and Preterm Birth, run by University Hospital Padova at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time of device positioning (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04944108, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2022.