Pierre Robin Sequence (PRS)PRS-3DCTNCT07257276
3D-CT-Based Prediction of Difficult Laryngoscopy in Infants With Pierre Robin Sequence
An observational study of Pierre Robin Sequence (PRS) and Difficult Laryngoscopy, run by Nanjing Children's Hospital at 1 site in China.
Trial summary
This study aims to develop and validate a quantitative prediction model using three-dimensional computed tomography (3D-CT) imaging for identifying infants with Pierre Robin sequence (PRS) at risk of difficult laryngoscopy. Read more about this study
- Who is it for?
- Ages 0 days to 3 months
- Conditions the study is for
- Pierre Robin Sequence (PRS), Difficult Laryngoscopy, Airway Management
- Type of treatment
- Injection or infusion
- How many people
- 294 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 31 Dec 2025
- 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 days to 3 months
- All sexes
- No healthy volunteers
- Child
Study population: This study included infants diagnosed with Pierre Robin sequence who underwent mandibular distraction osteogenesis under general anesthesia at Nanjing Children's Hospital between January 2023 and December 2025. All participants had complete preoperative 3D-CT imaging and intraoperative laryngoscopic grading records.
Who may be able to join
None listed.
Who cannot join
- Presence of other craniofacial syndromes (e.g., Treacher Collins syndrome, Goldenhar syndrome).
- Incomplete or poor-quality 3D-CT images.
- Missing laryngoscopic grading or intraoperative data.
- History of airway surgery before CT imaging.
Trial locations and contacts
1 site in 1 country.
China1 site
anjing Children's Hospital, Affiliated with Nanjing Medical University
Nanjing, Jiangsu, 210008
About this study
Official title: A 3D-CT-Based Dual-parameter Model for Predicting Difficult Laryngoscopy in Infants With Pierre Robin Sequence: Internal and Temporal External Validation
This study aims to develop and validate a quantitative prediction model using three-dimensional computed tomography (3D-CT) imaging for identifying infants with Pierre Robin sequence (PRS) at risk of difficult laryngoscopy. A dual-parameter model incorporating the oropharyngeal sagittal area (S2) and the distance between the tongue base and the posterior pharyngeal wall (D4) will be established. Internal validation will be performed using data from PRS infants treated between 2023 and 2024, and temporal external validation will be conducted using an independent cohort from 2025.
This study seeks to provide an accurate, non-invasive tool for preoperative airway risk assessment in PRS infants, thereby improving anesthetic safety and clinical decision-making.
Read the detailed description
This retrospective cohort study includes infants diagnosed with Pierre Robin sequence (PRS) who underwent mandibular distraction osteogenesis at the Children's Hospital of Nanjing Medical University between January 2023 and September 2025. Preoperative three-dimensional computed tomography (3D-CT) scans will be used to measure quantitative airway parameters, including the oropharyngeal sagittal area (S2) and the distance from the tongue base to the posterior pharyngeal wall (D4).
According to Cormack-Lehane grades obtained during laryngoscopy, infants will be classified into easy (grades I-II) and difficult (grades III-IV) exposure groups. Logistic regression will be used to identify independent predictors of difficult laryngoscopy, and a dual-parameter model combining S2 and D4 will be developed. The model's discrimination, calibration, and clinical usefulness will be assessed by receiver operating characteristic (ROC) curve analysis, calibration plots, and decision curve analysis (DCA).
Internal validation will be performed using bootstrap resampling (1000 iterations), and temporal external validation will be conducted using an independent cohort from 2025. The goal of this study is to construct a simple, objective, and reproducible model that can improve preoperative airway risk evaluation and support anesthetic management in PRS infants.
- Keywords
- 3D-CT, Quantitative Imaging, Difficult Airway, Infants, Prediction Model, Pierre Robin Sequence
- Medical subject headings
- Pierre Robin Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Easy Laryngoscopy Group | Infants with Pierre Robin sequence classified as Cormack-Lehane grade I-II during direct laryngoscopy. This group represents patients with easy laryngoscopic exposure. | |
| Difficult Laryngoscopy Group | Infants with Pierre Robin sequence classified as Cormack-Lehane grade III-IV during direct laryngoscopy. This group represents patients with difficult laryngoscopic exposure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive performance of the 3D-CT-based dual-parameter model for difficult laryngoscopy
The primary outcome is the discriminative ability of the 3D-CT-based dual-parameter model (including S2 and D4) to predict difficult laryngoscopy in infants with Pierre Robin sequence. Predictive performance will be assessed using area under the receiver operating characteristic curve (AUC), sensitivity, specificity, and calibration analysis.
Measured: From preoperative imaging (3D-CT) to intraoperative laryngoscopic exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start1 Jan 2023
- Primary completion31 Dec 2024
- 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 Pierre Robin Sequence (PRS)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
- Retrospective
- Enrolment
- 294 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hu Danling, Nanjing Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07257276
- Sponsor's protocol ID
- NanjingCH-PRS-2025
- Other IDs
- FYX202360
- Acronym
- PRS-3DCT
- Status last verified
- Nov 2025
- First submitted
- 20 Nov 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because this is a retrospective study involving patient privacy-sensitive information.
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 3D-CT-Based Dual-parameter Model for Predicting Difficult Laryngoscopy in Infants With Pierre Robin Sequence: Internal and Temporal External Validation
- ClinicalTrials.gov ID
- NCT07257276
- Acronym / sponsor ID
- PRS-3DCT / NanjingCH-PRS-2025
- Keywords
- 3D-CT, Quantitative Imaging, Difficult Airway, Infants, Prediction Model, Pierre Robin Sequence
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 294 participants (estimated)
- Lead sponsor
- Nanjing Children's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 2 Dec 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.
This study aims to develop and validate a quantitative prediction model using three-dimensional computed tomography (3D-CT) imaging for identifying infants with Pierre Robin sequence (PRS) at risk of difficult laryngoscopy. A dual-parameter model incorporating the oropharyngeal sagittal area (S2) and the distance between the tongue base and the posterior pharyngeal wall (D4) will be established. Internal validation will be performed using data from PRS infants treated between 2023 and 2024, and temporal external validation will be conducted using an independent cohort from 2025.
This study seeks to provide an accurate, non-invasive tool for preoperative airway risk assessment in PRS infants, thereby improving anesthetic safety and clinical decision-making.
Detailed description
This retrospective cohort study includes infants diagnosed with Pierre Robin sequence (PRS) who underwent mandibular distraction osteogenesis at the Children's Hospital of Nanjing Medical University between January 2023 and September 2025. Preoperative three-dimensional computed tomography (3D-CT) scans will be used to measure quantitative airway parameters, including the oropharyngeal sagittal area (S2) and the distance from the tongue base to the posterior pharyngeal wall (D4).
According to Cormack-Lehane grades obtained during laryngoscopy, infants will be classified into easy (grades I-II) and difficult (grades III-IV) exposure groups. Logistic regression will be used to identify independent predictors of difficult laryngoscopy, and a dual-parameter model combining S2 and D4 will be developed. The model's discrimination, calibration, and clinical usefulness will be assessed by receiver operating characteristic (ROC) curve analysis, calibration plots, and decision curve analysis (DCA).
Internal validation will be performed using bootstrap resampling (1000 iterations), and temporal external validation will be conducted using an independent cohort from 2025. The goal of this study is to construct a simple, objective, and reproducible model that can improve preoperative airway risk evaluation and support anesthetic management in PRS infants.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Easy Laryngoscopy Group | – | –Infants with Pierre Robin sequence classified as Cormack-Lehane grade I-II during direct laryngoscopy. This group represents patients with easy laryngoscopic exposure. |
| Difficult Laryngoscopy Group | – | –Infants with Pierre Robin sequence classified as Cormack-Lehane grade III-IV during direct laryngoscopy. This group represents patients with difficult laryngoscopic exposure. |
Who may qualify
- Ages
- 0 days to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- This study included infants diagnosed with Pierre Robin sequence who underwent mandibular distraction osteogenesis under general anesthesia at Nanjing Children's Hospital between January 2023 and December 2025. All participants had complete preoperative 3D-CT imaging and intraoperative laryngoscopic grading records.
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- Presence of other craniofacial syndromes (e.g., Treacher Collins syndrome, Goldenhar syndrome).
- Incomplete or poor-quality 3D-CT images.
- Missing laryngoscopic grading or intraoperative data.
- History of airway surgery before CT imaging.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Predictive performance of the 3D-CT-based dual-parameter model for difficult laryngoscopy
Time frame: From preoperative imaging (3D-CT) to intraoperative laryngoscopic exposure
The primary outcome is the discriminative ability of the 3D-CT-based dual-parameter model (including S2 and D4) to predict difficult laryngoscopy in infants with Pierre Robin sequence. Predictive performance will be assessed using area under the receiver operating characteristic curve (AUC), sensitivity, specificity, and calibration analysis.
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 2 Dec 2025.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because this is a retrospective study involving patient privacy-sensitive information.
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?
An observational study of Pierre Robin Sequence (PRS) and Difficult Laryngoscopy, run by Nanjing Children's Hospital at 1 site in China.
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 0 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 2 Dec 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 China. 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?
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?
Predictive performance of the 3D-CT-based dual-parameter model for difficult laryngoscopy (time frame: From preoperative imaging (3D-CT) to intraoperative laryngoscopic exposure). 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 2 Dec 2025.