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New 3D-CT model could help doctors safely manage airways in infants with rare facial condition

NCT ID NCT07257276

Knowledge-focused Sponsor: Nanjing Children's Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is developing a prediction tool using 3D-CT scans to identify which infants with Pierre Robin sequence (a condition with a small jaw and tongue that can block the airway) are likely to have a difficult time during breathing tube placement for surgery. Researchers will analyze scans from 294 infants to create a model based on two key measurements of the airway. The goal is to help anesthesiologists plan safer care for these vulnerable babies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could provide doctors with a reliable, non-invasive tool to predict airway difficulties before surgery in infants with Pierre Robin sequence, potentially reducing anesthesia risks.
What could go wrong
This is an observational study focused on developing a prediction model, not testing a treatment. The model may not perform as well in real-world settings or in infants with other conditions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 294 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2023

Expected to finish

Dec 2025

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

0 days to 3 months

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria:Infants diagnosed with Pierre Robin sequence (PRS) based on mandibular hypoplasia, glossoptosis, and upper airway obstruction. Undergoing mandibular distraction osteogenesis under general anesthesia. Complete preoperative 3D-CT imaging data available. Complete intraoperative laryngoscopic grading recorded (Cormack-Lehane classification). \- Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

isolated Pierre-Robin syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Airway management Difficult laryngoscopy Pierre Robin sequence (PRS)

Contacts and locations

Locations

  • anjing Children's Hospital, Affiliated with Nanjing Medical University

    Nanjing, Jiangsu, 210008, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.