NeonatologyNCT06316765
A Stylet Use May be Beneficial for Elective and Rescue Intubation of Prematurely Born Infants
An observational study of Neonatology, run by Charles University, Czech Republic.
Trial summary
Contrary to recent findings suggesting that stylets offer no advantage in general infant intubations, this study focuses on their potential benefits for premature infants undergoing elective or rescue intubation in the delivery room. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neonatology
- What is being tested?
- Intubation with stylet
- Type of treatment
- Surgery or procedure
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 31 Dec 2022
- Phase
- Observational
- 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
Study population: All premature infants born at less than 30 weeks gestation between 2016 and 2022 in the General Faculty Hospital in Prague were eligible for evaluation.
Who may be able to join
- intubation in the delivery room
Who cannot join
- both method used, video record not available
About this study
Official title: A Stylet Use May be Beneficial for Elective and Rescue Intubation of Prematurely Born Infants < 30 Weeks.
Contrary to recent findings suggesting that stylets offer no advantage in general infant intubations, this study focuses on their potential benefits for premature infants undergoing elective or rescue intubation in the delivery room. The goal is to compare the safety and efficiency of intubations with or without a stylet.
Read the detailed description
Recent studies have found that using a stylet does not offer any benefits during intubation across a diverse infant population. The research, however, specifically targets extremely and very premature infants undergoing elective or rescue intubation in the delivery room. A single-center retrospective observational study was conducted to compare the number of intubation attempts, the duration of intubation until successful, and the rate of associated desaturations exceeding 20%. The outcomes were determined through video recordings and statistical analysis.
- Conditions
- Neonatology
- Being tested
- Intubation with stylet
- Keywords
- Resuscitation, Extremely premature infant, Intubation, Stylet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intubation with styletProcedure or surgery
The cohort of premature infants was intubated with stylet.
| Study group | Role | What they receive |
|---|---|---|
| With stylet group | Intubation performed with stylet. Receives: Procedure: Intubation with stylet | |
| Without stylet group | Intubation performed without stylet. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome was defined as successful initial intubation attempt.
Successful placement of the endotracheal tube on the first intubation attempt, followed by an increase in heart rate and blood oxygen saturation.
Measured: immediately after procedure
Secondary outcomes (1)
Secondary outcomes was defined as the duration of intubation courses until successful placement of the endotracheal tube.
The duration from the first insertion of the laryngoscope blade to the successful placement of the endotracheal tube, followed by an increase in heart rate and blood oxygen saturation, measured in seconds.
Measured: immediately after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start1 Jan 2016
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeonatologyStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dunajová Klára, Charles University, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06316765
- Sponsor's protocol ID
- 118/10
- Status last verified
- Mar 2024
- First submitted
- 7 Mar 2024
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Stylet Use May be Beneficial for Elective and Rescue Intubation of Prematurely Born Infants < 30 Weeks.
- ClinicalTrials.gov ID
- NCT06316765
- Acronym / sponsor ID
- 118/10
- Conditions
- Neonatology
- Keywords
- Resuscitation, Extremely premature infant, Intubation, Stylet
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 18 Mar 2024 (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.
Contrary to recent findings suggesting that stylets offer no advantage in general infant intubations, this study focuses on their potential benefits for premature infants undergoing elective or rescue intubation in the delivery room. The goal is to compare the safety and efficiency of intubations with or without a stylet.
Detailed description
Recent studies have found that using a stylet does not offer any benefits during intubation across a diverse infant population. The research, however, specifically targets extremely and very premature infants undergoing elective or rescue intubation in the delivery room. A single-center retrospective observational study was conducted to compare the number of intubation attempts, the duration of intubation until successful, and the rate of associated desaturations exceeding 20%. The outcomes were determined through video recordings and statistical analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With stylet group | – | Procedure: Intubation with styletIntubation performed with stylet. |
| Without stylet group | – | –Intubation performed without stylet. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All premature infants born at less than 30 weeks gestation between 2016 and 2022 in the General Faculty Hospital in Prague were eligible for evaluation.
Key inclusion criteria (1 listed)
- intubation in the delivery room
Key exclusion criteria (1 listed)
- both method used, video record not available
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 |
|---|---|---|
| Intubation with styletThe cohort of premature infants was intubated with stylet. | Procedure or surgery | With stylet group |
Primary outcome
The primary outcome was defined as successful initial intubation attempt.
Time frame: immediately after procedure
Successful placement of the endotracheal tube on the first intubation attempt, followed by an increase in heart rate and blood oxygen saturation.
1 secondary outcome
Secondary outcomes was defined as the duration of intubation courses until successful placement of the endotracheal tube.
Time frame: immediately after procedure
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 19 Mar 2024.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatology, run by Charles University, Czech Republic.
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 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The primary outcome was defined as successful initial intubation attempt. (time frame: immediately after procedure). 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 19 Mar 2024.