Respiratory Distress Syndrome, NewbornNCT05399628
LISA Catheter With Marked vs. Unmarked Tip in Extremely Low Birth Weight Infants With RDS
A study testing Surfactant administration with less invasive surfactant administration (LISA) marked tip catheter and Surfactant administration with less invasive surfactant administration (LISA) unmarked tip catheter in people with Respiratory Distress Syndrome, Newborn, run by University Hospital Padova at 1 site in Italy.
Trial summary
This is an unblinded, randomized, controlled, crossover (AB/BA) trial of surfactant treatment with LISA catheter with a marked tip vs. LISA catheter with an unmarked tip 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, Newborn
- What is being tested?
- Surfactant administration with less invasive surfactant administration (LISA) marked tip catheter and Surfactant administration with less invasive surfactant administration (LISA) unmarked tip catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 6 Jun 2022to 11 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
- 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
- Refusal to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: LISA Catheter With Marked vs. Unmarked Tip 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 catheter with a marked tip vs. LISA catheter with an unmarked tip 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 positioning of the device at the correct depth in the trachea. The secondary outcome measures will be the time and number of attempts to achieve the correct depth and participant satisfaction.
Read the detailed description
Although less invasive surfactant administration (LISA) offers some advantages in ventilation procedure and neonatal outcomes, achieving the correct depth in the trachea using a LISA catheter may be difficult. This may have some drawbacks such as impaired surfactant administration (reducing the efficacy of the procedure) or prolonged duration of the laryngoscopy (aggravating the invasiveness of the procedure).
The aims of the present study should be: i) positioning of the device at the correct depth in the trachea, ii) time and number of attempts to achieve the correct depth, iii) participant satisfaction.
This is an unblinded, randomized, controlled, crossover (AB/BA) trial of surfactant treatment with LISA catheter with a marked tip vs. LISA catheter with an unmarked tip 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 positioning of the device at the correct depth in the trachea. The secondary outcome measures will be the time and number of attempts to achieve the correct depth and participant satisfaction.
- Conditions
- Respiratory Distress Syndrome, Newborn
- Being tested
- Surfactant administration with less invasive surfactant administration (LISA) marked tip catheter, Surfactant administration with less invasive surfactant administration (LISA) unmarked tip catheter
- Medical subject headings
- Respiratory Distress Syndrome, Newborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surfactant administration with less invasive surfactant administration (LISA) marked tip catheterDevice
Participants will be assigned to perform the procedure with LISA catheter with a marked tip
Surfactant administration with less invasive surfactant administration (LISA) unmarked tip catheterDevice
Participants will be assigned to perform the procedure with LISA catheter with an unmarked tip
| Study group | Role | What they receive |
|---|---|---|
| Surfactant administration with less invasive surfactant administration (LISA) marked tip catheter | Experimental | Participants will be assigned to perform the procedure with a LISA catheter with a marked tip Receives: Device: Surfactant administration with less invasive surfactant administration (LISA) marked tip catheter |
| Surfactant administration with less invasive surfactant administration (LISA) unmarked tip catheter | Active comparator | Participants will be assigned to perform the procedure with a LISA catheter with an unmarked tip Receives: Device: Surfactant administration with less invasive surfactant administration (LISA) unmarked tip catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who will achieve the positioning of the device at the correct depth in the trachea
Number of participants who will achieve the positioning of the device at the correct depth in the trachea (as assessed by the external observer using a laryngoscope).
Measured: 5 minutes
Secondary outcomes (3)
Time for positioning the device in the trachea
The time of device positioning will be defined as the time elapsed from the positioning of the laryngoscope in the manikin mouth to the connection of the syringe to the catheter
Measured: 5 minutes
Number of attempts for positioning the device in the trachea
The total number of attempts for positioning the device in the trachea
Measured: 5 minutes
Participant opinion on using the device
Participant opinion on using the device which will be evaluated using a Likert scale (1 worse outcome to 5 best outcome)
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 posted1 Jun 2022
- Study start6 Jun 2022
- Primary completion11 Jun 2022
- Study completion11 Jun 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 Syndrome, NewbornStudies 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
- Model description
- Participants in AB arm will be assigned to perform the procedure with LISA catheter with marked tip, followed by the procedure with LISA catheter with unmarked tip. Participants in BA arm will be assigned to the reverse sequence. A washout period of 6 hours (one procedure in the morning and one in the afternoon) will be included to reduce any carryover effect
- Masking
- None (open label)
- 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
- NCT05399628
- Sponsor's protocol ID
- NEOUNIPD2(2022)
- Status last verified
- Jul 2022
- First submitted
- 26 May 2022
- Last updated
- 26 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon motivated request to the corresponding author
Publications
Sweet DG, Carnielli V, Greisen G, Hallman M, Ozek E, Te Pas A, Plavka R, Roehr CC, Saugstad OD, Simeoni U, Speer CP, Vento M, Visser GHA, Halliday HL. European Consensus Guidelines on the Management of Respiratory Distress Syndrome - 2019 Update. Neonatology. 2019;115(4):432-450. doi: 10.1159/000499361. Epub 2019 Apr 11.
PubMed 30974433
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
- LISA Catheter With Marked vs. Unmarked Tip in Extremely Low Birth Weight Infants With RDS: a Crossover Randomized Controlled Manikin Trial
- ClinicalTrials.gov ID
- NCT05399628
- Acronym / sponsor ID
- NEOUNIPD2(2022)
- Conditions
- Respiratory Distress Syndrome, Newborn
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital PadovaUniversity, hospital or other
- Study start
- 6 Jun 2022 (actual)
- Primary completion
- 11 Jun 2022 (actual)
- Study completion
- 11 Jun 2022 (actual)
- First posted
- 1 Jun 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.
This is an unblinded, randomized, controlled, crossover (AB/BA) trial of surfactant treatment with LISA catheter with a marked tip vs. LISA catheter with an unmarked tip 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 positioning of the device at the correct depth in the trachea. The secondary outcome measures will be the time and number of attempts to achieve the correct depth and participant satisfaction.
Detailed description
Although less invasive surfactant administration (LISA) offers some advantages in ventilation procedure and neonatal outcomes, achieving the correct depth in the trachea using a LISA catheter may be difficult. This may have some drawbacks such as impaired surfactant administration (reducing the efficacy of the procedure) or prolonged duration of the laryngoscopy (aggravating the invasiveness of the procedure).
The aims of the present study should be: i) positioning of the device at the correct depth in the trachea, ii) time and number of attempts to achieve the correct depth, iii) participant satisfaction.
This is an unblinded, randomized, controlled, crossover (AB/BA) trial of surfactant treatment with LISA catheter with a marked tip vs. LISA catheter with an unmarked tip 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 positioning of the device at the correct depth in the trachea. The secondary outcome measures will be the time and number of attempts to achieve the correct depth and participant satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants in AB arm will be assigned to perform the procedure with LISA catheter with marked tip, followed by the procedure with LISA catheter with unmarked tip. Participants in BA arm will be assigned to the reverse sequence. A washout period of 6 hours (one procedure in the morning and one in the afternoon) will be included to reduce any carryover effect
| Arm | Type | Receives |
|---|---|---|
| Surfactant administration with less invasive surfactant administration (LISA) marked tip catheter | Experimental | Device: Surfactant administration with less invasive surfactant administration (LISA) marked tip catheterParticipants will be assigned to perform the procedure with a LISA catheter with a marked tip |
| Surfactant administration with less invasive surfactant administration (LISA) unmarked tip catheter | Active comparator | Device: Surfactant administration with less invasive surfactant administration (LISA) unmarked tip catheterParticipants will be assigned to perform the procedure with a LISA catheter with an unmarked tip |
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)
- Refusal to participate in the 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 |
|---|---|---|
| Surfactant administration with less invasive surfactant administration (LISA) marked tip catheterParticipants will be assigned to perform the procedure with LISA catheter with a marked tip | Device | Surfactant administration with less invasive surfactant administration (LISA) marked tip catheter |
| Surfactant administration with less invasive surfactant administration (LISA) unmarked tip catheterParticipants will be assigned to perform the procedure with LISA catheter with an unmarked tip | Device | Surfactant administration with less invasive surfactant administration (LISA) unmarked tip catheter |
Primary outcome
Number of participants who will achieve the positioning of the device at the correct depth in the trachea
Time frame: 5 minutes
Number of participants who will achieve the positioning of the device at the correct depth in the trachea (as assessed by the external observer using a laryngoscope).
3 secondary outcomes
Time for positioning the device in the trachea
Time frame: 5 minutes
Number of attempts for positioning the device in the trachea
Time frame: 5 minutes
Participant opinion on using the device
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 26 Jul 2022.
- Background: PubMed 30974433Sweet DG, Carnielli V, Greisen G, Hallman M, Ozek E, Te Pas A, Plavka R, Roehr CC, Saugstad OD, Simeoni U, Speer CP, Vento M, Visser GHA, Halliday HL. European Consensus Guidelines on the Management of Respiratory Distress Syndrome - 2019 Update. Neonatology. 2019;115(4):432-450. doi: 10.1159/000499361. Epub 2019 Apr 11.
- Individual participant dataSharing planned: Yes. The data will be available upon motivated request to the corresponding author
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surfactant administration with less invasive surfactant administration (LISA) marked tip catheter and Surfactant administration with less invasive surfactant administration (LISA) unmarked tip catheter in people with Respiratory Distress Syndrome, Newborn, run by University Hospital Padova at 1 site 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 1 site 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?
Number of participants who will achieve the positioning of the device at the correct depth in the trachea (time frame: 5 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 NCT05399628, 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 26 Jul 2022.