Respiratory Distress Syndrome in Preterm InfantsNCT05388175
LISA Rigid Catheter vs LISA Soft Catheter in a Very Preterm Manikin
A study testing Rigid catheter and Soft catheter in people with Respiratory Distress Syndrome in Preterm Infants, run by University Hospital Padova at 2 sites in Italy.
Trial summary
Less invasive surfactant administration (LISA) can be provided using rigid or soft catheters, but possible differences in terms of easiness of use and success of the procedure are unknown. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Respiratory Distress Syndrome in Preterm Infants
- What is being tested?
- Rigid catheter and Soft catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesItaly
- Study dates
- 25 May 2022to 5 Jun 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
- No healthy volunteers
- 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
Azienda Ospedaliera di Padova, University of Padova
Padova, 35128
About this study
Official title: Time of Device Positioning of LISA Rigid Catheter vs LISA Soft Catheter in a Very Preterm Manikin: A Crossover Randomized Controlled Trial
Less invasive surfactant administration (LISA) can be provided using rigid or soft catheters, but possible differences in terms of easiness of use and success of the procedure are unknown. A difficult procedure may have some drawbacks such as the prolonged duration of the laryngoscopy needed to insert the device, which is likely to aggravate the invasiveness of the procedure and result 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.
Read the detailed description
This is an unblinded, randomized, controlled, crossover (AB/BA) trial of surfactant treatment with LISA with a rigid catheter vs. LISA with a soft catheter 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 attempt, the number of attempts to achieve the correct positioning of the device in the trachea, the achievement of the correct depth of the catheter in the trachea, and the participant's opinion on using the device.
- Being tested
- Rigid catheter, Soft catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rigid catheterDevice
Also called Less invasive surfactant administration (LISA) with a rigid catheter
Participants will be invited to positioning a rigid catheter in the manikin's trachea for surfactant aministration
Soft catheterDevice
Also called Less invasive surfactant administration (LISA) with a soft catheter
Participants will be invited to positioning a rigid catheter in the manikin's trachea for surfactant aministration
| Study group | Role | What they receive |
|---|---|---|
| Less invasive surfactant administration (LISA) with a rigid catheter | Experimental | Participants will simulate the procedure of surfactant administration by using a rigid catheter Receives: Device: Rigid catheter |
| Less invasive surfactant administration (LISA) with a soft catheter | Active comparator | Participants will simulate the procedure of surfactant administration by using a soft catheter Receives: Device: Soft catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total time of device (catheter) positioning
The time of device positioning defined as the time elapsed from the positioning of the laryngoscope in the manikin mouth to the connection of the syringe for surfactant administration to the catheter
Measured: 5 minutes
Secondary outcomes (3)
Success of device positioning at the first attempt
We will evaluate the success of the device (catheter) at the first attempt
Measured: 1 minute
Achievement of the correct depth of the catheter in the trachea
The correct depth of the catheter tip in the trachea will be evaluated by an external observer
Measured: 5 minutes
Participant's opinion regarding the procedure
Participant's opinion regarding the feasibility or difficulty of the procedure will be evaluated by using a questionnaire with items (1 worse to 5 best outcome) to be evaluated by a Likert scale
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start25 May 2022
- Primary completion5 Jun 2022
- Study completion5 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress Syndrome in Preterm InfantsStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 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
- NCT05388175
- Sponsor's protocol ID
- NEOUNIPD1(2022)
- Status last verified
- Jul 2022
- First submitted
- 18 May 2022
- Last updated
- 26 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be shared upon motivated request to the PI
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time of Device Positioning of LISA Rigid Catheter vs LISA Soft Catheter in a Very Preterm Manikin: A Crossover Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05388175
- Acronym / sponsor ID
- NEOUNIPD1(2022)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital PadovaUniversity, hospital or other
- Study start
- 25 May 2022 (actual)
- Primary completion
- 5 Jun 2022 (actual)
- Study completion
- 5 Jun 2022 (actual)
- First posted
- 24 May 2022 (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.
Less invasive surfactant administration (LISA) can be provided using rigid or soft catheters, but possible differences in terms of easiness of use and success of the procedure are unknown. A difficult procedure may have some drawbacks such as the prolonged duration of the laryngoscopy needed to insert the device, which is likely to aggravate the invasiveness of the procedure and result 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.
Detailed description
This is an unblinded, randomized, controlled, crossover (AB/BA) trial of surfactant treatment with LISA with a rigid catheter vs. LISA with a soft catheter 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 attempt, the number of attempts to achieve the correct positioning of the device in the trachea, the achievement of the correct depth of the catheter in the trachea, and the participant's opinion on using the device.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Less invasive surfactant administration (LISA) with a rigid catheter | Experimental | Device: Rigid catheterParticipants will simulate the procedure of surfactant administration by using a rigid catheter |
| Less invasive surfactant administration (LISA) with a soft catheter | Active comparator | Device: Soft catheterParticipants will simulate the procedure of surfactant administration by using a soft catheter |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not 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 |
|---|---|---|
| Rigid catheterAlso: Less invasive surfactant administration (LISA) with a rigid catheterParticipants will be invited to positioning a rigid catheter in the manikin's trachea for surfactant aministration | Device | Less invasive surfactant administration (LISA) with a rigid catheter |
| Soft catheterAlso: Less invasive surfactant administration (LISA) with a soft catheterParticipants will be invited to positioning a rigid catheter in the manikin's trachea for surfactant aministration | Device | Less invasive surfactant administration (LISA) with a soft catheter |
Primary outcome
Total time of device (catheter) positioning
Time frame: 5 minutes
The time of device positioning defined as the time elapsed from the positioning of the laryngoscope in the manikin mouth to the connection of the syringe for surfactant administration to the catheter
3 secondary outcomes
Success of device positioning at the first attempt
Time frame: 1 minute
Achievement of the correct depth of the catheter in the trachea
Time frame: 5 minutes
Participant's opinion regarding the procedure
Time frame: 5 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 26 Jul 2022.
- Individual participant dataSharing planned: Yes. The data will be shared upon motivated request to the PI
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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 Rigid catheter and Soft catheter in people with Respiratory Distress Syndrome in Preterm Infants, 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 26 Jul 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?
Total time of device (catheter) positioning (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jul 2022.