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Cleft Palate clinical trials

View clinical trials related to Cleft Palate.

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NCT ID: NCT06420336 Not yet recruiting - Opioid Use Clinical Trials

QL vs LAI for Palatoplasty

Start date: July 1, 2024
Phase: N/A
Study type: Interventional

This study will consist of patients ages 6-18 who are undergoing a surgery on the hard or soft palate of the mouth (palatoplasty), with removal of bone from the front of the hip (anterior iliac bone graft harvesting). The patients will be randomized to receive either a unilateral QL block by an anesthesiologist, or local anesthetic infiltration at the surgical incision by the surgeon. The primary aim will be assessing post-operative pain in the first 48 hours after surgery. Secondary outcomes will include pain medication use in the first 48 hours after surgery, block resolution time, and evaluating any complications associated with the QL block or local anesthetic infiltration.

NCT ID: NCT06408337 Recruiting - Clinical trials for Cleft Lip and Palate

Phase I-IIa, to Evaluate the Safety, Feasibility, and Efficacy of the Use of BIOCLEFT in the Treatment of Cleft Palate.

Start date: April 17, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

Phase I/II, controlled, open-label, randomized, single site clinical trial to assess the safety and feasibility, as well as hint efficacy evidence of a bioengineered palate mucosa substitute on nanostructured fibrin-agarose scaffolds with autologous mucosa tissue-specific cells (culture-expanded fibroblasts and keratinocytes), for tissue replacement and repair of donor area after the reconstruction of palate cleft defects (staphylorraphy), in comparison with standard care for donor mucosa.

NCT ID: NCT06381713 Not yet recruiting - Clinical trials for Cleft Lip and Palate

Effect and Cost-utility of of High Intensity vs. Low Intensity Speech Intervention in Children With Cleft Palate

Start date: August 2024
Phase: N/A
Study type: Interventional

Achieving speech that is understandable and acceptable to others is the key outcome in cleft treatment. Therefore, speech therapy provided by a speech-language pathologist is necessary. This intervention is traditionally provided twice per week for 30 minutes for months or even years by first-line speech-language pathologists. Unfortunately, this low intensity intervention is based on a historical context rather than scientific evidence. This means that current speech therapy knows several shortcomings including poor outcomes, treatment fatigue and high costs related to year-long therapy. Because of these issues, the use of high intensity speech intervention is proposed. Even though solid proof-of-concepts exist for this model, it has not yet found its way into clinical practice. Before this intensity can be implemented and utilized in clinical practice, the effect of this novel program on a larger societal scale must be determined. This project will compare the effect of high intensity and low intensity speech intervention in children with a cleft palate in terms of speech, quality of life, and cost-utility as provided by first-line speech-language pathologists by conducting a large-scale randomized controlled trial. The final goal is to utilize this program in clinical practice and to create awareness of the benefits for children with a cleft palate among stakeholders.

NCT ID: NCT06338319 Enrolling by invitation - Clinical trials for Cleft Lip and Palate

Book Sharing for Toddlers With Clefts

BOOST
Start date: April 16, 2024
Phase: N/A
Study type: Interventional

Children with clefts exhibit difficulty with language and literacy compared to children without clefts. However, little is known about interventions to address these difficulties in the cleft population. This study will test the efficacy of a parent-focused dialogic book-sharing intervention for toddlers with isolated cleft palate. The study will use a randomized controlled trial (RCT) design and Intention to Treat (ITT) analyses. Child outcomes include expressive and receptive language. Parent outcomes of interest include the frequency and quality of shared reading interactions. To assess mechanisms of action, the study will test whether changes in child outcomes are mediated by changes in parents' behavior. Analyses will also explore heterogeneity in outcomes to determine whether the intervention is more effective in certain clinical or demographic sub-groups.

NCT ID: NCT06229587 Completed - Cleft Palate Clinical Trials

Furlow With Buccinator and Velopharyngeal Function

Start date: February 1, 2024
Phase: N/A
Study type: Interventional

Assessment of speech and the middle ear function of patients between the age of 3 and 7 years surgically treated by ARC (Furlow z-palatoplasty with a buccinator myomucosal flap) was done. Middle ear function was assessed by clinical otoscopic examination and by tympanometry to detect the presence or absence of middle ear effusion and the need for tympanostomy tubes. Speech outcomes were assessed using perceptual speech assessment for the degree of hypernasality, compensatory misarticulation and speech intelligibility. Nasopharyngoscopic examination of the patients was done for visualization of the velopharyngeal port, allowing assessment of the pattern and grade of velopharyngeal closure during speech and the presence or absence of a velopharyngeal gap

NCT ID: NCT06151340 Completed - Clinical trials for Delayed Language in Cleft Palate

Delayed Language Development in Children With Cleft Palate at Sohag University Hospital

Start date: September 1, 2017
Phase:
Study type: Observational

This is a retrospective study on children with cleft palate who came to the multidisciplinary cleft clinic at Sohag University Hospital from September 2017 to September 2023

NCT ID: NCT06143254 Recruiting - Clinical trials for Cleft Palate Children

Effect of Infant Sign Training on Speech-language Development

Start date: November 9, 2023
Phase: N/A
Study type: Interventional

Children born with a cleft lip and palate (CLP) are known to be at risk for speech-language disorders that impact academic and social emotional growth. Even at very young ages (<3 years), speech-language disorders are already observed. It is hypothesized that speech-language intervention delivered before the age of 3 years old could decrease the impact of CLP on speech-language development. This would result in a decreased need for speech-language therapy on the long-term and a reduced burden of care on children, families and health services. However, no evidence is yet available to support any specific model of early speech-language intervention in this population. Consequently, no standardized clinical practice guidelines are available yet. Symbolic gesture training in combination with verbal input expands the natural communication of young children including multimodal speech-language input (i.e., verbal and manual input) via caregivers who act as co-therapists. To contribute to the evidence-based practice in the field of cleft speech therapy, this research project aims to determine the effectiveness and feasibility of symbolic gesture training in one-year old children with CLP by comparing different intervention approaches based on perceptual, psychosocial and qualitative outcome measures.

NCT ID: NCT06105099 Recruiting - Clinical trials for Cleft Lip and Palate

Effect of Performance-specific Cleft Speech Intervention and Long-term Learning in Children With a Cleft Palate

Start date: October 1, 2022
Phase: N/A
Study type: Interventional

Speech therapy in children with a palate deals with two scientific challenges that will be addressed in this project. The first challenge is selecting the best speech approach for a child with a specific cleft speech characteristic (CSC). Many speech therapists use a 'one-size-fits-all' approach to treat compensatory CSCs resulting in poor short- and long-term speech outcomes. To increase the effectiveness and quality of cleft speech care, it is necessary to find the best match between a specific therapy and a given type of CSC. Therefore, this proposal will compare the effect of 3 different speech approaches on the speech and quality of life in Dutch speaking children with different types of CSCs. The second challenge is selecting the best speech approach to enhance long-term learning and transfer of newly established speech skills to untrained consonants. To date, research mainly focused on immediate therapy effects. It is unknown if permanent speech changes occur. Hence, this project will also investigate the short-term and long-term learning effects (retention and transfer) of the different speech approaches from the first objective. This proposal will improve evidence-based and patient-tailored cleft speech therapy.

NCT ID: NCT06103162 Completed - Cleft Palate Clinical Trials

Comparison of Different Feeding Appliances for Cleft Palate Babies

Start date: July 1, 2023
Phase: N/A
Study type: Interventional

This study will compare flexible , rigid feeding plates and a special feeding bottle for children with cleft palate.

NCT ID: NCT06100315 Not yet recruiting - Clinical trials for Complication Following Peripheral Nerve Block

Nalbuphine as Adjuvant During Bilateral Suprazygomatic Maxillary Nerve Block for Pediatric Cleft Palate Repair

Start date: December 2023
Phase:
Study type: Observational

The aim of this study is to evaluate the efficacy of adding nalbuphine to bupivacaine via suprazygomatic nerve block for postoperative pain control and emergence agitation management in pediatrics aged from to 1 to 7 years who were maintained on sevoflurane inhalational anesthesia and scheduled for cleft lip and palate operation.