Preterm NeonatesNCT07073105
Tracheal Ultrasound for Confirmation of ETT Placement in NICU
A study testing tracheal ultrasound ( expert radiologist), tracheal ultrasound by trainee neonatologist and Chest x-ray in people with Preterm Neonates and Mechanical Ventilation, run by Ain Shams University at 1 site in Egypt.
Trial summary
Improper placement of the endotracheal tube during intubation can lead to dangerous complications. It has been reported that chest radiography is the gold standard method for validation of endotracheal tube (ET) position . Read more about this study
- Who is it for?
- Ages 1 hour to 30 days
- Conditions the study is for
- Preterm Neonates, Mechanical Ventilation, Endotracheal Tube
- What is being tested?
- tracheal ultrasound ( expert radiologist), tracheal ultrasound by trainee neonatologist and Chest x-ray
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2023to 1 Jun 2024
- 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 1 hour to 30 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Less than 35weeks gestational age
- Invasive mechanical ventilation via ETT.
Who cannot join
- Upper air way anomalies.
- eligible patients whose care team deemed enrollment will disrupt patient care.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasonography for Confirmation of Endotracheal Tube Placement in Preterm in Neonatal Intensive Care Unit: Expert Versus Trainee
Improper placement of the endotracheal tube during intubation can lead to dangerous complications. It has been reported that chest radiography is the gold standard method for validation of endotracheal tube (ET) position .
This study will compare the effectiveness of endotracheal tube position obtained by ultrasonography vs that obtained by chest X-ray with two operators an expert and a trainee in preterm neonates.
This study will work to the extent that the trainee has the ability to do sonar for premature babies with the same efficiency as an ultrasound specialist.
Read the detailed description
neonate in the neonatal intensive care unit (NICU) are intubated for different reasons and most of these patients undergo chest X-rays (CXRs) several times during their ICU admission to confirm endotracheal tube (ETT) placement, monitor severity of cardiopulmonary illness, and detect complications of other indwelling devices Although the amount of radiation exposure is minimal with CXRs, exposure to multiple CXRs in NICU patients, especially in preterm, results in accumulated radiation burden over time. This can lead to tissue damage and is associated with an increased risk of malignancy Tracheal ultrasonography is technique for confirmation of proper endotracheal intubation. Potential advantages include detection of both main stem and esophageal intubation and less time to image availability than CXR and less radiation Point of care ultrasound (POCUS) of the anterior neck is increasingly used by emergency physicians and anesthesiologists to detect endotracheal and esophageal intubation. It is more accurate and faster than physical examination and capnography, with adult meta-analyses reporting that it has sensitivities of 93-98%, specificities of 97-98% We will explore effectiveness and reproducibility of tracheal ultrasonography done by in hospital neonatologist trainee in the technique vs the expert radiologist in determination of ET position.
- Conditions
- Preterm Neonates, Mechanical Ventilation, Endotracheal Tube
- Being tested
- tracheal ultrasound ( expert radiologist), tracheal ultrasound by trainee neonatologist, Chest x-ray
- Keywords
- tracheal ultrasound in preterm neonates for ETT confirmation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tracheal ultrasound ( expert radiologist)Diagnostic test
tracheal ultrasound, performed by expert radiologist, for preterm neonates for confirmation of ETT site
tracheal ultrasound by trainee neonatologistDiagnostic test
tracheal ultrasound, performed by trainee neonatologist ( after receiving training for the procedure) , for preterm neonates for confirmation of ETT site
Chest x-rayDiagnostic test
chest xray done for confirmation of ETT site
| Study group | Role | What they receive |
|---|---|---|
| confirmation of ETT by CXR | Active comparator | confirmation of ETT site by CXR the gold standard Receives: Diagnostic Test: Chest x-ray |
| ETT site confirmation by trainee tracheal ultrasound | Experimental | confirmation of ETT site was done by tracheal ultrasound performed by a trainee neonatologist after receiving training for the procedure Receives: Diagnostic Test: tracheal ultrasound by trainee neonatologist |
| ETT site confirmation by expert tracheal ultrasound | Experimental | confirmation of ETT tube site by expert radiologist performing tracheal ultrasound Receives: Diagnostic Test: tracheal ultrasound ( expert radiologist) |
What is being measured
The primary outcome is the main question the study is designed to answer.
time in minutes to receive tracheal ultrasound by trainee neonatologist results for ETT site
Time taken from giving order to perform the tracheal ultrasound by trainee neonatologist to receiving the results of the imaging
Measured: 24 hours
time in minutes to receive CXR results for ETT site
Time taken from giving order to perform chest x ray to receiving the results of the imaging
Measured: 24 hours
time in minutes to receive tracheal ultrasound by expert radiologist results for ETT site
Time taken from giving order to perform the tracheal ultrasound by expert radiologist to receiving the results of the imaging
Measured: 24 hours
reproducibility of results between CXR , expert and trainee tracheal ultrasound
Accuracy of the findings of the tracheal ultrasound by expert, trainee and chest x ray for the same patient
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start1 Jun 2023
- Primary completion1 Jan 2024
- Study completion1 Jun 2024
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 Preterm NeonatesStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Ibrahim, Ain Shams University
- Investigators
- mariam ibrahim, MD, PHD, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07073105
- Sponsor's protocol ID
- Tracheal Ultrasound NICU
- Status last verified
- Jul 2025
- First submitted
- 6 Jul 2025
- Last updated
- 18 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: individual participant data can be shared after publication from the corresponding author upon reasonable request
Publications
Ibrahim MJA, Elbarbary MNED, Yacoub GEE, Abdo MAM. Confirmation and reproducibility of endotracheal tube position by tracheal ultrasonography in preterms: expert versus trainee. Eur J Pediatr. 2025 Dec 9;185(1):2. doi: 10.1007/s00431-025-06626-3.
PubMed 41364152
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonography for Confirmation of Endotracheal Tube Placement in Preterm in Neonatal Intensive Care Unit: Expert Versus Trainee
- ClinicalTrials.gov ID
- NCT07073105
- Acronym / sponsor ID
- Tracheal Ultrasound NICU
- Conditions
- Preterm Neonates, Mechanical Ventilation, Endotracheal Tube
- Keywords
- tracheal ultrasound in preterm neonates for ETT confirmation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 18 Jul 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.
Improper placement of the endotracheal tube during intubation can lead to dangerous complications. It has been reported that chest radiography is the gold standard method for validation of endotracheal tube (ET) position .
This study will compare the effectiveness of endotracheal tube position obtained by ultrasonography vs that obtained by chest X-ray with two operators an expert and a trainee in preterm neonates.
This study will work to the extent that the trainee has the ability to do sonar for premature babies with the same efficiency as an ultrasound specialist.
Detailed description
neonate in the neonatal intensive care unit (NICU) are intubated for different reasons and most of these patients undergo chest X-rays (CXRs) several times during their ICU admission to confirm endotracheal tube (ETT) placement, monitor severity of cardiopulmonary illness, and detect complications of other indwelling devices Although the amount of radiation exposure is minimal with CXRs, exposure to multiple CXRs in NICU patients, especially in preterm, results in accumulated radiation burden over time. This can lead to tissue damage and is associated with an increased risk of malignancy Tracheal ultrasonography is technique for confirmation of proper endotracheal intubation. Potential advantages include detection of both main stem and esophageal intubation and less time to image availability than CXR and less radiation Point of care ultrasound (POCUS) of the anterior neck is increasingly used by emergency physicians and anesthesiologists to detect endotracheal and esophageal intubation. It is more accurate and faster than physical examination and capnography, with adult meta-analyses reporting that it has sensitivities of 93-98%, specificities of 97-98% We will explore effectiveness and reproducibility of tracheal ultrasonography done by in hospital neonatologist trainee in the technique vs the expert radiologist in determination of ET position.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| confirmation of ETT by CXR | Active comparator | Diagnostic Test: Chest x-rayconfirmation of ETT site by CXR the gold standard |
| ETT site confirmation by trainee tracheal ultrasound | Experimental | Diagnostic Test: tracheal ultrasound by trainee neonatologistconfirmation of ETT site was done by tracheal ultrasound performed by a trainee neonatologist after receiving training for the procedure |
| ETT site confirmation by expert tracheal ultrasound | Experimental | Diagnostic Test: tracheal ultrasound ( expert radiologist)confirmation of ETT tube site by expert radiologist performing tracheal ultrasound |
Who may qualify
- Ages
- 1 hour to 30 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Less than 35weeks gestational age
- Invasive mechanical ventilation via ETT.
Key exclusion criteria (2 listed)
- Upper air way anomalies.
- eligible patients whose care team deemed enrollment will disrupt patient care.
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 |
|---|---|---|
| tracheal ultrasound ( expert radiologist)tracheal ultrasound, performed by expert radiologist, for preterm neonates for confirmation of ETT site | Diagnostic test | ETT site confirmation by expert tracheal ultrasound |
| tracheal ultrasound by trainee neonatologisttracheal ultrasound, performed by trainee neonatologist ( after receiving training for the procedure) , for preterm neonates for confirmation of ETT site | Diagnostic test | ETT site confirmation by trainee tracheal ultrasound |
| Chest x-raychest xray done for confirmation of ETT site | Diagnostic test | confirmation of ETT by CXR |
Primary outcome
time in minutes to receive tracheal ultrasound by trainee neonatologist results for ETT site
Time frame: 24 hours
Time taken from giving order to perform the tracheal ultrasound by trainee neonatologist to receiving the results of the imaging
time in minutes to receive CXR results for ETT site
Time frame: 24 hours
Time taken from giving order to perform chest x ray to receiving the results of the imaging
time in minutes to receive tracheal ultrasound by expert radiologist results for ETT site
Time frame: 24 hours
Time taken from giving order to perform the tracheal ultrasound by expert radiologist to receiving the results of the imaging
reproducibility of results between CXR , expert and trainee tracheal ultrasound
Time frame: 24 hours
Accuracy of the findings of the tracheal ultrasound by expert, trainee and chest x ray for the same patient
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 Jul 2025.
- Derived from this study: PubMed 41364152Ibrahim MJA, Elbarbary MNED, Yacoub GEE, Abdo MAM. Confirmation and reproducibility of endotracheal tube position by tracheal ultrasonography in preterms: expert versus trainee. Eur J Pediatr. 2025 Dec 9;185(1):2. doi: 10.1007/s00431-025-06626-3.
- Individual participant dataSharing planned: Yes. individual participant data can be shared after publication from the corresponding author upon reasonable request
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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.
mariam ibrahim, MD, PHD principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tracheal ultrasound ( expert radiologist), tracheal ultrasound by trainee neonatologist and Chest x-ray in people with Preterm Neonates and Mechanical Ventilation, run by Ain Shams University at 1 site in Egypt.
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 2 inclusion and 2 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 Jul 2025. 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 Egypt. 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 in minutes to receive tracheal ultrasound by trainee neonatologist results for ETT site (time frame: 24 hours). The study lists 4 primary outcomes in all. 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 NCT07073105, 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 Jul 2025.