Respiratory Distress Syndrome (Neonatal)NEU-VODEtecNCT06758492
A Prospective Observational Study of Video Laryngoscopy Versus Direct Laryngoscopy for Insertion of a Thin Endotracheal Catheter for Surfactant Administration in Newborn Infants
An observational study of Respiratory Distress Syndrome (Neonatal) and Respiratory Distress Syndrome (RDS), run by University College Dublin at 16 sites in 9 countries.
Trial summary
Many premature babies have breathing difficulty after birth and receive help with a breathing machine (nasal continuous positive airway pressure, NCPAP). Some of the babies whose breathing gets worse despite NCPAP are treated with surfactant, a medication that is given directly into their windpipe (trachea). Read more about this study
- Who is it for?
- Ages 0 minutes to 28 days
- Conditions the study is for
- Respiratory Distress Syndrome (Neonatal), Respiratory Distress Syndrome (RDS), Video Laryngoscopy
- What is being tested?
- Video laryngoscopy used to insert thin endotracheal catheter and Direct laryngoscopy used to insert thin endotracheal catheter
- Type of treatment
- Medical device
- How many people
- 600 participants
- Where
- 16 sitesin 9 countries
- Study dates
- 13 Jan 2025to 31 Dec 2025
- How long will I take part?
- 600 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 0 minutes to 28 days
- All sexes
- No healthy volunteers
- Child
Study population: Newborn infants (<28 days old) who have a thin catheter inserted into their trachea for the purpose of surfactant administration ("less-invasive surfactant administration", LISA)
Who may be able to join
- newborn infants of any sex who are are having a thin catheter inserted into their trachea for the purpose of surfactant administration
Who cannot join
- no parental consent provided to share their data
Trial locations and contacts
16 sites in 9 countries. Contact the study team or a site near you to ask about taking part.
Janneke Dekker, PhD contact
16 sites in 9 countries
Poland4 sites, 4 recruiting
- Recruiting
Medical University of Gdańsk
Gdansk
Joanna Jassem-Bobowicz, MD
- Recruiting
Medical University of Silesia
Katowice
Iwona Chudek Maruniak, MD
- Recruiting
Poznań University of Medical Sciences
Poznan
Tomasz Szczapa, MD PhD
- Recruiting
Provincial Hospital No. 2
Rzeszów
Witold Blaz, MD
Czechia3 sites, 3 recruiting
- Recruiting
University Hospital Brno
Brno
Andrea Stanikova, MD
- Recruiting
General University Hospital
Prague
Tereza Lamberská, MD PhD
- Recruiting
Institute for Mother and Child Care
Prague
Milena Tušková, MD
Croatia2 sites, 2 recruiting
- Recruiting
Clinical Hospital Centre
Rijeka
Iva Bilić Čače, MD PhD
- Recruiting
Clinical Hospital "Holy Spirit"
Zagreb
Rebeka Ribičić, MD
Romania2 sites, 2 recruiting
- Recruiting
Clinical County Emergency Hospital
Sibiu
Maria Livia Ognean, MD PhD
- Recruiting
George Emil Palade University
Târgu Mureş
Manuela Curcerea, MD PhD
Greece1 site, 1 recruiting
- Recruiting
Aristotle University of Thessaloniki
Thessaloniki
Kosmas Sarafidis, MD
Hungary1 site, 1 recruiting
- Not yet recruiting
Second Semmelweiss University
Budapest
Zsuzsanna Nagy, MD
Italy1 site, 1 recruiting
- Not yet recruiting
University of Padova
Padova
Daniele Trevisanuto, MD PhD
Norway1 site, 1 recruiting
- Recruiting
Oslo University Hospital
Oslo
Anne Lee Solevåg, MD PhD
Spain1 site, 1 recruiting
- Recruiting
University and Polytechnic Hospital La Fe
Valencia
Raquel Escrig Fernández, MD PhD
About this study
Many premature babies have breathing difficulty after birth and receive help with a breathing machine (nasal continuous positive airway pressure, NCPAP). Some of the babies whose breathing gets worse despite NCPAP are treated with surfactant, a medication that is given directly into their windpipe (trachea). Some of the babies who are given surfactant get it through a ventilation tube (endotracheal tube, ETT), while others get it through a thin catheter that is too small for ventilation. When doctors insert a tube or a thin catheter into the windpipe of a baby, they use an instrument called a laryngoscope, which has a light at its tip, to identify the entrance. Most often doctors look directly into the baby's mouth with a standard laryngoscope to identify the entrance to the windpipe. However, newer video laryngoscopes have a camera along with the light at their tip, which displays a picture of the entrance to the windpipe on a screen. In a study performed at one hospital, doctors inserted an ETT first time more often when they used a video laryngoscope.
The investigators are doing a study at many hospitals where doctors usually use a standard laryngoscope to insert tubes and thin catheters into a baby's trachea by looking directly into the mouth. Each hospital will switch one-by-one to using a video laryngoscope when inserting a tube. The investigators will compare the information we collect to see if more babies who have a tube inserted first time without falls in their oxygen levels or heart rate with a video laryngoscope. The investigators will also collect information on babies who have a thin catheter inserted to compare whether doctors use fewer attempts when they use a video laryngoscope.
Read the detailed description
Many newborn infants have breathing difficulty after birth, particularly when they are born prematurely. Many of these infants are supported with nasal continuous positive airway pressure (NCPAP). Some of the infants deteriorate despite treatment with NCPAP and have a thin catheter inserted into their trachea for the administration of surfactant, which is then immediately removed (often referred to as "less-invasive surfactant administration" or LISA). Insertion of a thin catheter is usually performed by doctors who are experienced at intubation (i.e. inserting endotracheal tubes, ETTs). They look directly into the the infants mouth using a standard laryngoscope to identify the opening of the airway (i.e. perform direct laryngoscopy). More recently video laryngoscopes have been developed. These devices display a magnified image of the airway on a screen that can be viewed indirectly by the doctor attempting to insert the ETT or thin catheter, and also by others. A single centre study reported that more infants were successfully intubated at the first attempt when doctors performed indirect video laryngoscopy compared to direct laryngoscopy.
It is possible to independently verify when a doctor has correctly inserted and ETT, for example by detecting carbon dioxide coming out of the tube or seeing condensation in the tube during exhalation, or by hearing breath sounds by listening to the chest during positive pressure inflations. It is not possible to independently verify whether a doctor has correctly inserted a thin catheter under direct laryngoscopy, by these or other means. The standard (and to date only) way of confirming that a thin catheter has been correctly inserted is to rely on the report of the operator. Video laryngoscopy, in contrast, allows the independent verification of the tip of a thin catheter by one or more people observing the screen.
The investigators are performing NEU-VODE, a stepped wedge cluster randomised study of the introduction of video laryngoscopy versus direct laryngoscopy for the intubation of newborn infants. Alongside this study, the investigators are performing a study of infants who have a thin endotracheal catheter inserted under video laryngoscopy versus direct laryngoscopy. As it is not possible to measure the outcome of successful insertion of the thin catheter equally in both groups, this is a prospective observational cohort study. The investigators will record information on infants who have a thin catheter inserted into the trachea for the purpose of surfactant administration at centres participating in the NEU-VODE study. The type of laryngoscope used for thin catheter insertion attempts will not be mandated; instead, the investigators will compare the information of groups within the cohort who have their first attempt made using the video laryngoscope to the group who have their first attempt made with direct laryngoscopy.
- Conditions
- Respiratory Distress Syndrome (Neonatal), Respiratory Distress Syndrome (RDS), Video Laryngoscopy, Surfactant
- Being tested
- Video laryngoscopy used to insert thin endotracheal catheter, Direct laryngoscopy used to insert thin endotracheal catheter
- Keywords
- infant, newborn, respiratory distress syndrome, surfactant, video laryngoscopy
- Medical subject headings
- Pulmonary Atelectasis, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video laryngoscopy used to insert thin endotracheal catheterDevice
Video laryngoscopy used to insert thin endotracheal catheter
Direct laryngoscopy used to insert thin endotracheal catheterDevice
Direct laryngoscopy used to insert thin endotracheal catheter
| Study group | Role | What they receive |
|---|---|---|
| Video laryngoscopy used to insert thin endotracheal catheter | Video laryngoscopy used to insert thin endotracheal catheter Receives: Device: Video laryngoscopy used to insert thin endotracheal catheter | |
| Direct laryngoscopy used to insert thin endotracheal catheter | Direct laryngoscopy used to insert thin endotracheal catheter Receives: Device: Direct laryngoscopy used to insert thin endotracheal catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful thin catheter insertion at the first attempt without physiologic instability
Successful thin catheter insertion at the first attempt without fall in SpO2 >20% from baseline or HR<100bpm
Measured: At 30 minutes from the start of the insertion attempt
Secondary outcomes (14)
Successful thin catheter insertion at the first attempt
Successful thin catheter insertion at the first attempt
Measured: At 30 minutes from the start of the insertion attempt
Physiologic instability during first thin endotracheal catheter insertion attempt
Fall in SpO2>20% from baseline or HR<100bpm during first thin endotracheal catheter insertion attempt
Measured: At 30 minutes from the start of the insertion attempt
Duration of laryngoscopy of first insertion attempt
Interval from introduction of laryngoscopy blade to its removal (seconds)
Measured: At 30 minutes from the start of the insertion attempt
Number of attempts taken to insert thin endotracheal catheter
Number of attempts taken to insert thin endotracheal catheter
Measured: At 30 minutes from the start of the insertion attempt
Time taken to insert thin endotracheal catheter on successful attempt
Interval from insertion of laryngoscope blade to insertion of thin endotracheal catheter on successful attempt (seconds)
Measured: At 30 minutes from the start of the insertion attempt
Total laryngoscopy time to successful insertion
Sum of all intervals from introduction of laryngoscope blade to removal for unsuccessful insertion attempts; plus interval from introduction of blade to catheter insertion for successful attempt in seconds
Measured: At 30 minutes from the start of the insertion attempt
Lowest oxygen saturation (SpO2) during the procedure
Lowest oxygen saturation (SpO2) during the procedure
Measured: At 30 minutes from the start of the insertion attempt
Lowest heart rate (HR) during the procedure
Lowest heart rate (HR) during the procedure
Measured: At 30 minutes from the start of the insertion attempt
Oral trauma
Oral trauma reported by clinicians
Measured: At 1 hour from the start of the insertion attempt
Chest compressions
Chest compressions
Measured: At 1 hour from the start of the insertion attempt
Adrenaline
Adrenaline
Measured: At 1 hour from the start of the insertion attempt
Further thin catheter surfactant treatment
Further thin catheter surfactant treatment
Measured: Within 72 hours of insertion attempt
Endotracheal intubation and ventilation
Endotracheal intubation and ventilation
Measured: Within 72 hours of insertion attempt
Surfactant treatment via endotracheal tube
Surfactant treatment via endotracheal tube
Measured: Within 72 hours of insertion attempt
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start13 Jan 2025
- Primary completion13 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress Syndrome (Neonatal)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
- Target duration
- 600 Days
Sponsor and investigators
- Lead sponsor
- University College Dublin
- Sponsor type
- University, hospital or other
- Collaborators
- Leiden University Medical Center
- Responsible party
- Sponsor
- Investigators
- Colm P.F. O'Donnell, MB PhD, Principal investigator, National Maternity Hospital, Dublin, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06758492
- Sponsor's protocol ID
- NEU-VODEtec 01
- Acronym
- NEU-VODEtec
- Status last verified
- Feb 2025
- First submitted
- 20 Dec 2024
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared o consideration of reasonable request to investigators
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study of Video Laryngoscopy Versus Direct Laryngoscopy for Insertion of a Thin Endotracheal Catheter for Surfactant Administration in Newborn Infants
- ClinicalTrials.gov ID
- NCT06758492
- Acronym / sponsor ID
- NEU-VODEtec / NEU-VODEtec 01
- Conditions
- Respiratory Distress Syndrome (Neonatal), Respiratory Distress Syndrome (RDS), Video Laryngoscopy, Surfactant
- Keywords
- infant, newborn, respiratory distress syndrome, surfactant, video laryngoscopy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University College DublinUniversity, hospital or other
- Collaborators
- Leiden University Medical Center
- Study start
- 13 Jan 2025 (actual)
- Primary completion
- 13 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 3 Jan 2025 (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.
Many premature babies have breathing difficulty after birth and receive help with a breathing machine (nasal continuous positive airway pressure, NCPAP). Some of the babies whose breathing gets worse despite NCPAP are treated with surfactant, a medication that is given directly into their windpipe (trachea). Some of the babies who are given surfactant get it through a ventilation tube (endotracheal tube, ETT), while others get it through a thin catheter that is too small for ventilation. When doctors insert a tube or a thin catheter into the windpipe of a baby, they use an instrument called a laryngoscope, which has a light at its tip, to identify the entrance. Most often doctors look directly into the baby's mouth with a standard laryngoscope to identify the entrance to the windpipe. However, newer video laryngoscopes have a camera along with the light at their tip, which displays a picture of the entrance to the windpipe on a screen. In a study performed at one hospital, doctors inserted an ETT first time more often when they used a video laryngoscope.
The investigators are doing a study at many hospitals where doctors usually use a standard laryngoscope to insert tubes and thin catheters into a baby's trachea by looking directly into the mouth. Each hospital will switch one-by-one to using a video laryngoscope when inserting a tube. The investigators will compare the information we collect to see if more babies who have a tube inserted first time without falls in their oxygen levels or heart rate with a video laryngoscope. The investigators will also collect information on babies who have a thin catheter inserted to compare whether doctors use fewer attempts when they use a video laryngoscope.
Detailed description
Many newborn infants have breathing difficulty after birth, particularly when they are born prematurely. Many of these infants are supported with nasal continuous positive airway pressure (NCPAP). Some of the infants deteriorate despite treatment with NCPAP and have a thin catheter inserted into their trachea for the administration of surfactant, which is then immediately removed (often referred to as "less-invasive surfactant administration" or LISA). Insertion of a thin catheter is usually performed by doctors who are experienced at intubation (i.e. inserting endotracheal tubes, ETTs). They look directly into the the infants mouth using a standard laryngoscope to identify the opening of the airway (i.e. perform direct laryngoscopy). More recently video laryngoscopes have been developed. These devices display a magnified image of the airway on a screen that can be viewed indirectly by the doctor attempting to insert the ETT or thin catheter, and also by others. A single centre study reported that more infants were successfully intubated at the first attempt when doctors performed indirect video laryngoscopy compared to direct laryngoscopy.
It is possible to independently verify when a doctor has correctly inserted and ETT, for example by detecting carbon dioxide coming out of the tube or seeing condensation in the tube during exhalation, or by hearing breath sounds by listening to the chest during positive pressure inflations. It is not possible to independently verify whether a doctor has correctly inserted a thin catheter under direct laryngoscopy, by these or other means. The standard (and to date only) way of confirming that a thin catheter has been correctly inserted is to rely on the report of the operator. Video laryngoscopy, in contrast, allows the independent verification of the tip of a thin catheter by one or more people observing the screen.
The investigators are performing NEU-VODE, a stepped wedge cluster randomised study of the introduction of video laryngoscopy versus direct laryngoscopy for the intubation of newborn infants. Alongside this study, the investigators are performing a study of infants who have a thin endotracheal catheter inserted under video laryngoscopy versus direct laryngoscopy. As it is not possible to measure the outcome of successful insertion of the thin catheter equally in both groups, this is a prospective observational cohort study. The investigators will record information on infants who have a thin catheter inserted into the trachea for the purpose of surfactant administration at centres participating in the NEU-VODE study. The type of laryngoscope used for thin catheter insertion attempts will not be mandated; instead, the investigators will compare the information of groups within the cohort who have their first attempt made using the video laryngoscope to the group who have their first attempt made with direct laryngoscopy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 600 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video laryngoscopy used to insert thin endotracheal catheter | – | Device: Video laryngoscopy used to insert thin endotracheal catheterVideo laryngoscopy used to insert thin endotracheal catheter |
| Direct laryngoscopy used to insert thin endotracheal catheter | – | Device: Direct laryngoscopy used to insert thin endotracheal catheterDirect laryngoscopy used to insert thin endotracheal catheter |
Who may qualify
- Ages
- 0 minutes to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Newborn infants (<28 days old) who have a thin catheter inserted into their trachea for the purpose of surfactant administration ("less-invasive surfactant administration", LISA)
Key inclusion criteria (1 listed)
- newborn infants of any sex who are are having a thin catheter inserted into their trachea for the purpose of surfactant administration
Key exclusion criteria (1 listed)
- no parental consent provided to share their data
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 |
|---|---|---|
| Video laryngoscopy used to insert thin endotracheal catheterVideo laryngoscopy used to insert thin endotracheal catheter | Device | Video laryngoscopy used to insert thin endotracheal catheter |
| Direct laryngoscopy used to insert thin endotracheal catheterDirect laryngoscopy used to insert thin endotracheal catheter | Device | Direct laryngoscopy used to insert thin endotracheal catheter |
Primary outcome
Successful thin catheter insertion at the first attempt without physiologic instability
Time frame: At 30 minutes from the start of the insertion attempt
Successful thin catheter insertion at the first attempt without fall in SpO2 >20% from baseline or HR<100bpm
14 secondary outcomes
Successful thin catheter insertion at the first attempt
Time frame: At 30 minutes from the start of the insertion attempt
Physiologic instability during first thin endotracheal catheter insertion attempt
Time frame: At 30 minutes from the start of the insertion attempt
Duration of laryngoscopy of first insertion attempt
Time frame: At 30 minutes from the start of the insertion attempt
Number of attempts taken to insert thin endotracheal catheter
Time frame: At 30 minutes from the start of the insertion attempt
Time taken to insert thin endotracheal catheter on successful attempt
Time frame: At 30 minutes from the start of the insertion attempt
Total laryngoscopy time to successful insertion
Time frame: At 30 minutes from the start of the insertion attempt
Lowest oxygen saturation (SpO2) during the procedure
Time frame: At 30 minutes from the start of the insertion attempt
Lowest heart rate (HR) during the procedure
Time frame: At 30 minutes from the start of the insertion attempt
Oral trauma
Time frame: At 1 hour from the start of the insertion attempt
Chest compressions
Time frame: At 1 hour from the start of the insertion attempt
Adrenaline
Time frame: At 1 hour from the start of the insertion attempt
Further thin catheter surfactant treatment
Time frame: Within 72 hours of insertion attempt
Endotracheal intubation and ventilation
Time frame: Within 72 hours of insertion attempt
Surfactant treatment via endotracheal tube
Time frame: Within 72 hours of insertion attempt
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Individual participant dataSharing planned: Yes. Data will be shared o consideration of reasonable request to investigators
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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.
Janneke Dekker, PhD contact
Colm P.F. O'Donnell, MB PhD principal investigator
National Maternity Hospital, Dublin, Ireland
16 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Distress Syndrome (Neonatal) and Respiratory Distress Syndrome (RDS), run by University College Dublin at 16 sites in 9 countries.
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: looking for participants now, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Poland, Czechia, Croatia, Romania, Greece and 4 more countries. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Colm P.F. O'Donnell, MB PhD (+35316373100, codonnell@nmh.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful thin catheter insertion at the first attempt without physiologic instability (time frame: At 30 minutes from the start of the insertion attempt). 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 20 Feb 2025.