3D-printed protective obturators to aid anesthesia for infants with cleft lip and palate

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center, randomized intervention will enroll pediatric patients undergoing primary repair for cleft lip, alveolus, and/or palate and assign them 1:1 by day of operation to receive either a custom 3D-printed protective obturator used during intubation or the standard airway management without the obturator. For the intervention arm, clinicians will obtain an intraoral scan before surgery, design a negative impression, and produce a patient-specific obturator by 3D printing and casting. Patients are categorized by type and timing of repair (neonatal lip repair versus later palate or combined repairs) and follow standard anesthesiology monitoring and outcome collection. The trial focuses on peri-intubation airway management, device fit, and immediate anesthetic safety endpoints in a pediatric cleft center.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Pediatric patients with unilateral or bilateral cleft lip and alveolus (U/BCLA) or unilateral or bilateral cleft lip, alveolus and palate (total cleft; U/BCLAP) who underwent primary lip reconstruction within 0-3 months of age (most often at our workplace in the neonatal period)
* Pediatric patients with isolated cleft palate (ICP) and patients with unilateral or bilateral cleft lip, alveolus and palate (U/BCLAP) who underwent primary cleft reconstruction between 6 and 18 months of age.

Exclusion Criteria:

* unilateral or bilateral cleft lip without cleft alveolus
* patients with genetically confirmed syndrome disability
* orofacial cleft patients with associated congenital malformations that may affect the course of anesthesia (atresia of the choanae)
* patients with atypical clefts of the face
* patients with CLA, CLAP, ICP who underwent primary cleft lip reconstruction later than at 3 months of age
* patients with CLAP and ICP who underwent primary cleft reconstruction later than at 18 months of age
* patients with submucous cleft palate
* patients with airways secured preoperatively
* patients on artificial lung ventilation
* patients with coagulopathy, thrombocytopenia/thrombocytopathy
* patients at risk of malignant hyperthermia
* patients for whom the consent of legal representatives to the research project has not been obtained

Where it's running

• University hospital Brno
  Brno, Jihomoravská Kraj, Czechia Recruiting

Study contacts

• Study coordinator: Michaela Richtorvá, MD.
• Email: richtrova.michaela@fnbrno.cz
• Phone: 532234693

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.