Endotracheal Tube Tip PositionELEGANTNCT04393337
Estimating Length of Endotracheal Tube Insertion Using Gestational Age or Nasal-Tragus Length in Newborn Infants
A study testing Gestational Age Chart Method and Nasal-Tragus Length Method in people with Endotracheal Tube Tip Position and Bronchopulmonary Dysplasia, run by Princess Nourah Bint Abdulrahman University at 3 sites in Saudi Arabia.
Trial summary
Endotracheal intubation is a life-saving intervention that few infants need after birth. Although an endotracheal tube is the most reliable way of providing positive-pressure breath, the critical factor that determines the maximal efficacy of positive-pressure ventilation is the optimal placement of the endotracheal… Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- Endotracheal Tube Tip Position, Bronchopulmonary Dysplasia, Pneumothorax
- What is being tested?
- Gestational Age Chart Method and Nasal-Tragus Length Method
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 454 participants
- Where
- 3 sitesSaudi Arabia
- Study dates
- 15 Jun 2020to Dec 2023
- 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 day to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants (less than 28 days of life) between 23 weeks 0 days and 41 weeks 6 days gestational age
- Infants requiring oral intubation in the delivery room or in neonatal intensive care unit
Who cannot join
- Infants with major chromosomal anomalies, including trisomy 13, trisomy 18, and trisomy 21
- Infants with major anomalies, including craniofacial anomalies and facial dysmorphism that may affect the nasal-tragus length
Trial locations and contacts
3 sites in 1 country.
Saudi Arabia3 sites, 3 recruiting
- Recruiting
King Fahad Hospital, AlBaha University
Al Bahah
Jameel Alghamdi, 00966555770733, dr.jameelalghamdi@hotmail.com
- Recruiting
King Abdullah bin Abdulaziz University Hospital
Riyadh, 13412
Abdul Razak, MD, 0118200000 ext. 3526, aarazak@kaauh.edu.sa
Abdul Razak, MD
- Recruiting
King Faisal Specialist Hospital & Research Centre
Riyadh
Abdulaziz Binmanee, 00966565454292, zizmaze@hotmail.com
About this study
Official title: Gestational Age Versus Nasal-tragus Length for Estimating Endotracheal Tube Insertion Depth in Newborns - A Randomised Trial
Endotracheal intubation is a life-saving intervention that few infants need after birth. Although an endotracheal tube is the most reliable way of providing positive-pressure breath, the critical factor that determines the maximal efficacy of positive-pressure ventilation is the optimal placement of the endotracheal tube tip. There are various methods available to determine the initial depth of endotracheal tube (ETT) that are based on the infant's birth weight, gestational age, anthropometric measurements, and others include vocal cord guide and suprasternal palpation methods.
The Neonatal Resuscitation Program (NRP) textbook, in its 7th edition of the textbook, recommends a gestational age chart and nasal-tragus length method for estimating endotracheal tube insertion depth during cardiopulmonary resuscitation of the neonate. The evidence to support these two methods is, however, limited. Hence, we designed this study to determine the accuracy of two methods, gestational age chart and nasal-tragus length method, recommended by the Neonatal Resuscitation Program.
Read the detailed description
Trial Objective: To determine whether estimating ETT insertion depth using gestational age chart rather than nasal-tragus length method results in more correctly positioned ETT tips.
Setting: The neonates will be recruited from multiple tertiary-level neonatal intensive care units in Saudi Arabia. A neonate can participate in more than one clinical trial, depending on the interventions being given. Parallel run trials will be discussed between the chief and local principal investigators whether or not joint recruitment is feasible to both parties.
Informed Consent: We will obtain written consent after the parents have been given a full verbal explanation and written description. We will explain to the parents in their own native language. We will use a hospital-based adult interpreter wherein required. We will obtain deferred consent (after initial verbal assent) where prior consent is not feasible as the study does not involve additional risk or investigations to the participants, and the interventions are otherwise considered as standard practice recommendations by the NRP.
Data Safety Monitoring Board: Any unexpected serious events (death, any life-threatening event, any event that will prolong the hospitalization or any event that will result in disability) will be reported to the data safety monitoring committee. The trial steering committee will receive recommendations from the data safety monitoring board if the trial requires early termination following the interim data analyses and evidence from relevant studies. The following measures were agreed to consider stopping the trial, wholly or partly (subgroups), after an interim analysis, that will be done after recruiting 200 participants.
- An absolute difference of greater than or equal to 25% in the primary outcome between the study groups.
- An absolute difference of less than 5% in the primary outcome between the study groups.
- A rate of less than 20% in the primary outcome in either of the groups.
Sample Size: Our unpublished data showed using the nasal-tragus length method results in 35% of correctly positioned ETT tips in term and preterm infants. The data is similar to the randomized and non-randomized studies that showed an accuracy between 32 and 37 percent using the nasal-tragus length method. With 90% power and two-sided 5% significance, to detect an absolute increase in optimally positioned ETT tips of 15%, we will require 454 participants. We calculated sample size using nQuery Advisor Sample Size Calculator version 8.3.0.0.
Statistical Analysis: We will analyze the data based on the intention-to-treat principle. Univariate analyses will be performed to compare baseline demographic factors between the two groups. A mean with standard deviation (normal data) or median with interquartile range (skewed data) will be obtained for continuous variables and numbers and percentages for categorical variables. Independent T-test (normal data) or Mann Whitney U test (skewed data) for continuous variables and chi-square test (or Fisher's exact test as appropriate) for categorical variables will be used for analyses between the groups. Statistical Analysis Software version 9.4 will be used for the conduct of all analyses.
Analysis of primary outcome: Adjusted risk ratios of a successful outcome will be calculated along with 95% confidence intervals. Adjusted ratios will be determined by way of multivariable logistic regression analysis, including co-variates deemed biologically to have an influence on the primary outcome (gestational age, small for gestational age, and center). Principles of best model practices will be followed (including assessment of collinearity amongst included variables) as well as the determination of the predictive ability of the model using area under the curve.
Analysis of secondary outcomes: Similar analyses as above will be performed for all secondary outcomes that are categorical variables. The risk ratios of secondary outcomes mortality, oxygen therapy at 28 days, pneumothorax, and bronchopulmonary dysplasia will be adjusted based on the following variables: gestational age, male sex, small for gestational age, maternal hypertension, chorioamnionitis, antenatal steroids, and center if the P-value is less than 0.25 on univariate analysis.
- Conditions
- Endotracheal Tube Tip Position, Bronchopulmonary Dysplasia, Pneumothorax, Death, Duration, Ventilator
- Being tested
- Gestational Age Chart Method, Nasal-Tragus Length Method
- Medical subject headings
- Bronchopulmonary Dysplasia, Pneumothorax, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gestational Age Chart MethodOther
The endotracheal tube insertion depth is obtained by the gestational age chart
Nasal-Tragus Length MethodOther
The endotracheal tube insertion depth is obtained by the nasal-tragus method formula
| Study group | Role | What they receive |
|---|---|---|
| Gestational Age Chart Method | Experimental | In this method, the endotracheal tube insertion depth is obtained from the gestational age chart provided in the 7th edition textbook of neonatal resuscitation program (adapted from Kempley et al. PubMed identifier number: 18372092) Receives: Other: Gestational Age Chart Method |
| Nasal-Tragus Length Method | Active comparator | In this method, the endotracheal tube insertion depth is calculated based on the formula-the distance from nasal septum tip to ear tragus+1 cm Receives: Other: Nasal-Tragus Length Method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of infants with optimally positioned endotracheal tube tip on the chest X-ray
Endotracheal tube tip is considered optimally positioned if the tip lies between upper border of first thoracic vertebra (T1) and the lower border of second thoracic vertebra (T2) on the chest X-ray. While obtaining the antero-posterior view chest X-ray in supine position, the infant's head, neck and chest is placed in the midline with no tension on the endotracheal tube and neck being in neutral position (i.e. neck neither flexed nor extended). Just before obtaining the film, the investigator/research assistant should re-confirm that the endotracheal tube is secured in a standardize manner at the estimated depth based on the treatment arm assigned.
Measured: within 4 hours of endotracheal intubation
Secondary outcomes (8)
Proportion of infants with endotracheal tube tip above T1 vertebra
Presence of endotracheal tube tip above the upper border of first thoracic vertebra e of endotracheal tube tip below the lower border of second thoracic vertebra on the chest X-ray
Measured: within 4 hours of endotracheal intubation
Proportion of infants with endotracheal tube tip below T2 vertebra
Presence of endotracheal tube tip below the lower border of second thoracic vertebra on the chest X-ray
Measured: within 4 hours of endotracheal intubation
Proportion of infants with pneumothorax
Presence of air in the pleural space determined by a chest X-ray
Measured: 36 weeks of post-menstrual age
Proportion of infants with requiring endotracheal tube repositioning (advance or withdrawn) following chest X-ray
Repositioning of the endotracheal tube will be done based on attendings discretion
Measured: 24 hours
Proportion of infants with oxygen therapy
Any supplemental oxygen (>21%) on invasive or non-invasive respiratory support
Measured: 28 days from the birth
Proportion of infants with bronchopulmonary dysplasia
It is defined as oxygen therapy or positive pressure support (include nasal cannula <2 liter/minute and >30% oxygen, nasal cannula >2 liters/minute and any oxygen, continuous positive airway pressure and any oxygen, or invasive respiratory support and any oxygen)
Measured: 36 weeks of post-menstrual age
Ventilation days
Duration of invasive ventilation
Measured: 36 weeks of post-menstrual age
Proportion of infants with mortality
Death occurring anytime from birth until discharge
Measured: 36 weeks of post-menstrual age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start15 Jun 2020
- Primary completionJun 2023 (estimated)
- Study completionDec 2023 (estimated)
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 Endotracheal Tube Tip PositionStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible infants will be randomly assigned (1:1) to the 'gestational age chart' or 'nasal-tragus length' method We will stratify the randomization by gestational age at birth (\<28 weeks and \>28 weeks) and participating center. An independent researcher will generate the randomization sequence with a computer at the website www.sealedenvelope.com hosted by King Abdullah bin Abdulaziz University Hospital, Saudi Arabia. The researcher will upload the sequence to the in-built randomization module within the Research Electronic Data Capture (REDCap) system. The sequence is inaccessible to the trial investigators. We will conceal the allocation by incorporating the random permuted blocks of size 2 and 4 sequences within the REDCap system.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 454 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Princess Nourah Bint Abdulrahman University
- Sponsor type
- University, hospital or other
- Collaborators
- King Fahad Hospital, King Faisal Specialist Hospital & Research Center
- Responsible party
- Principal investigator, Abdul Razak, Princess Nourah Bint Abdulrahman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04393337
- Sponsor's protocol ID
- 20-0148
- Acronym
- ELEGANT
- Status last verified
- Oct 2021
- First submitted
- 11 May 2020
- Last updated
- 25 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Razak A, Faden M, Alghamdi J, Binmanee A, Alonazi AH, Hamdoun A, Almugaiteeb S, Patel W, Katar H, Lora F, Alismail A, Lavery A, Hamama I, Alsaleem N, Alshaikh M, Alrasheed L, Aldibasi O. Randomised trial estimating length of endotracheal tube insertion using gestational age or nasal-tragus length in newborns: a study protocol. BMJ Open. 2022 Jan 19;12(1):e055628. doi: 10.1136/bmjopen-2021-055628.
PubMed 35046004
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gestational Age Versus Nasal-tragus Length for Estimating Endotracheal Tube Insertion Depth in Newborns - A Randomised Trial
- ClinicalTrials.gov ID
- NCT04393337
- Acronym / sponsor ID
- ELEGANT / 20-0148
- Conditions
- Endotracheal Tube Tip Position, Bronchopulmonary Dysplasia, Pneumothorax, Death, Duration, Ventilator
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 454 participants (estimated)
- Lead sponsor
- Princess Nourah Bint Abdulrahman UniversityUniversity, hospital or other
- Collaborators
- King Fahad Hospital, King Faisal Specialist Hospital & Research Center
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 19 May 2020 (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.
Endotracheal intubation is a life-saving intervention that few infants need after birth. Although an endotracheal tube is the most reliable way of providing positive-pressure breath, the critical factor that determines the maximal efficacy of positive-pressure ventilation is the optimal placement of the endotracheal tube tip. There are various methods available to determine the initial depth of endotracheal tube (ETT) that are based on the infant's birth weight, gestational age, anthropometric measurements, and others include vocal cord guide and suprasternal palpation methods.
The Neonatal Resuscitation Program (NRP) textbook, in its 7th edition of the textbook, recommends a gestational age chart and nasal-tragus length method for estimating endotracheal tube insertion depth during cardiopulmonary resuscitation of the neonate. The evidence to support these two methods is, however, limited. Hence, we designed this study to determine the accuracy of two methods, gestational age chart and nasal-tragus length method, recommended by the Neonatal Resuscitation Program.
Detailed description
Trial Objective: To determine whether estimating ETT insertion depth using gestational age chart rather than nasal-tragus length method results in more correctly positioned ETT tips.
Setting: The neonates will be recruited from multiple tertiary-level neonatal intensive care units in Saudi Arabia. A neonate can participate in more than one clinical trial, depending on the interventions being given. Parallel run trials will be discussed between the chief and local principal investigators whether or not joint recruitment is feasible to both parties.
Informed Consent: We will obtain written consent after the parents have been given a full verbal explanation and written description. We will explain to the parents in their own native language. We will use a hospital-based adult interpreter wherein required. We will obtain deferred consent (after initial verbal assent) where prior consent is not feasible as the study does not involve additional risk or investigations to the participants, and the interventions are otherwise considered as standard practice recommendations by the NRP.
Data Safety Monitoring Board: Any unexpected serious events (death, any life-threatening event, any event that will prolong the hospitalization or any event that will result in disability) will be reported to the data safety monitoring committee. The trial steering committee will receive recommendations from the data safety monitoring board if the trial requires early termination following the interim data analyses and evidence from relevant studies. The following measures were agreed to consider stopping the trial, wholly or partly (subgroups), after an interim analysis, that will be done after recruiting 200 participants.
- An absolute difference of greater than or equal to 25% in the primary outcome between the study groups.
- An absolute difference of less than 5% in the primary outcome between the study groups.
- A rate of less than 20% in the primary outcome in either of the groups.
Sample Size: Our unpublished data showed using the nasal-tragus length method results in 35% of correctly positioned ETT tips in term and preterm infants. The data is similar to the randomized and non-randomized studies that showed an accuracy between 32 and 37 percent using the nasal-tragus length method. With 90% power and two-sided 5% significance, to detect an absolute increase in optimally positioned ETT tips of 15%, we will require 454 participants. We calculated sample size using nQuery Advisor Sample Size Calculator version 8.3.0.0.
Statistical Analysis: We will analyze the data based on the intention-to-treat principle. Univariate analyses will be performed to compare baseline demographic factors between the two groups. A mean with standard deviation (normal data) or median with interquartile range (skewed data) will be obtained for continuous variables and numbers and percentages for categorical variables. Independent T-test (normal data) or Mann Whitney U test (skewed data) for continuous variables and chi-square test (or Fisher's exact test as appropriate) for categorical variables will be used for analyses between the groups. Statistical Analysis Software version 9.4 will be used for the conduct of all analyses.
Analysis of primary outcome: Adjusted risk ratios of a successful outcome will be calculated along with 95% confidence intervals. Adjusted ratios will be determined by way of multivariable logistic regression analysis, including co-variates deemed biologically to have an influence on the primary outcome (gestational age, small for gestational age, and center). Principles of best model practices will be followed (including assessment of collinearity amongst included variables) as well as the determination of the predictive ability of the model using area under the curve.
Analysis of secondary outcomes: Similar analyses as above will be performed for all secondary outcomes that are categorical variables. The risk ratios of secondary outcomes mortality, oxygen therapy at 28 days, pneumothorax, and bronchopulmonary dysplasia will be adjusted based on the following variables: gestational age, male sex, small for gestational age, maternal hypertension, chorioamnionitis, antenatal steroids, and center if the P-value is less than 0.25 on univariate analysis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Eligible infants will be randomly assigned (1:1) to the 'gestational age chart' or 'nasal-tragus length' method We will stratify the randomization by gestational age at birth (<28 weeks and >28 weeks) and participating center. An independent researcher will generate the randomization sequence with a computer at the website www.sealedenvelope.com hosted by King Abdullah bin Abdulaziz University Hospital, Saudi Arabia. The researcher will upload the sequence to the in-built randomization module within the Research Electronic Data Capture (REDCap) system. The sequence is inaccessible to the trial investigators. We will conceal the allocation by incorporating the random permuted blocks of size 2 and 4 sequences within the REDCap system.
| Arm | Type | Receives |
|---|---|---|
| Gestational Age Chart Method | Experimental | Other: Gestational Age Chart MethodIn this method, the endotracheal tube insertion depth is obtained from the gestational age chart provided in the 7th edition textbook of neonatal resuscitation program (adapted from Kempley et al. PubMed identifier number: 18372092) |
| Nasal-Tragus Length Method | Active comparator | Other: Nasal-Tragus Length MethodIn this method, the endotracheal tube insertion depth is calculated based on the formula-the distance from nasal septum tip to ear tragus+1 cm |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Infants (less than 28 days of life) between 23 weeks 0 days and 41 weeks 6 days gestational age
- Infants requiring oral intubation in the delivery room or in neonatal intensive care unit
Key exclusion criteria (2 listed)
- Infants with major chromosomal anomalies, including trisomy 13, trisomy 18, and trisomy 21
- Infants with major anomalies, including craniofacial anomalies and facial dysmorphism that may affect the nasal-tragus length
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 |
|---|---|---|
| Gestational Age Chart MethodThe endotracheal tube insertion depth is obtained by the gestational age chart | Other | Gestational Age Chart Method |
| Nasal-Tragus Length MethodThe endotracheal tube insertion depth is obtained by the nasal-tragus method formula | Other | Nasal-Tragus Length Method |
Primary outcome
Proportion of infants with optimally positioned endotracheal tube tip on the chest X-ray
Time frame: within 4 hours of endotracheal intubation
Endotracheal tube tip is considered optimally positioned if the tip lies between upper border of first thoracic vertebra (T1) and the lower border of second thoracic vertebra (T2) on the chest X-ray. While obtaining the antero-posterior view chest X-ray in supine position, the infant's head, neck and chest is placed in the midline with no tension on the endotracheal tube and neck being in neutral position (i.e. neck neither flexed nor extended). Just before obtaining the film, the investigator/research assistant should re-confirm that the endotracheal tube is secured in a standardize manner at the estimated depth based on the treatment arm assigned.
8 secondary outcomes
Proportion of infants with endotracheal tube tip above T1 vertebra
Time frame: within 4 hours of endotracheal intubation
Proportion of infants with endotracheal tube tip below T2 vertebra
Time frame: within 4 hours of endotracheal intubation
Proportion of infants with pneumothorax
Time frame: 36 weeks of post-menstrual age
Proportion of infants with requiring endotracheal tube repositioning (advance or withdrawn) following chest X-ray
Time frame: 24 hours
Proportion of infants with oxygen therapy
Time frame: 28 days from the birth
Proportion of infants with bronchopulmonary dysplasia
Time frame: 36 weeks of post-menstrual age
Ventilation days
Time frame: 36 weeks of post-menstrual age
Proportion of infants with mortality
Time frame: 36 weeks of post-menstrual age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2021.
- Derived from this study: PubMed 35046004Razak A, Faden M, Alghamdi J, Binmanee A, Alonazi AH, Hamdoun A, Almugaiteeb S, Patel W, Katar H, Lora F, Alismail A, Lavery A, Hamama I, Alsaleem N, Alshaikh M, Alrasheed L, Aldibasi O. Randomised trial estimating length of endotracheal tube insertion using gestational age or nasal-tragus length in newborns: a study protocol. BMJ Open. 2022 Jan 19;12(1):e055628. doi: 10.1136/bmjopen-2021-055628.
- Individual participant dataSharing planned: No
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.
King Fahad Hospital, AlBaha University
Al Bahah, Saudi Arabia
King Abdullah bin Abdulaziz University Hospital
Riyadh, Saudi Arabia
King Faisal Specialist Hospital & Research Centre
Riyadh, Saudi Arabia
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gestational Age Chart Method and Nasal-Tragus Length Method in people with Endotracheal Tube Tip Position and Bronchopulmonary Dysplasia, run by Princess Nourah Bint Abdulrahman University at 3 sites in Saudi Arabia.
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: status not confirmed, as of the sponsor's last update on 25 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Saudi Arabia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of infants with optimally positioned endotracheal tube tip on the chest X-ray (time frame: within 4 hours of endotracheal intubation). 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 NCT04393337, 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 25 Oct 2021.