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New treatment option for Cleft Lip and Palate
Official title Use of Computer Aided Design and 3D Printing for Anesthesiology Management in a Pediatric Patient With Cleft Facial Defect
ClinicalTrials.gov ID: NCT04422847
What this study is testing
- What it's testing
- Congenital malformations of the orofacial area are the most common congenital malformations in children with an incidence of 1.8 children with orofacial cleft per 1000 healthy births in the Czech Republic. The care of children with cleft facial defects is multidisciplinary, centralized and takes place from birth to adulthood.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 2
You may be able to join if
- Pediatric patients with unilateral or bilateral cleft lip and alveolus (U/BCLA) or unilateral or bilateral cleft lip, alveolus and palate (total...
- Pediatric patients with isolated cleft palate (ICP) and patients with unilateral or bilateral cleft lip, alveolus and palate (U/BCLAP) who underwent...
You likely can't join if
- 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
See the full eligibility 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...
- 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Brno, Jihomoravská Kraj, Czechia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 2 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brno, Jihomoravská Kraj, Czechia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.