Cleft palate is a gap in the roof of the mouth present at birth, affecting about 1 in 1,600 babies in the U.S. Standard treatment involves surgical repair in the first year or two of life, followed by speech therapy and sometimes additional surgeries. Research now focuses on improving surgical outcomes, understanding genetic causes, and preventing complications like ear infections and feeding difficulties.
What's actually going on in research
Trials are testing surgical techniques that may improve speech outcomes and reduce the need for additional procedures. Studies examine genetic factors that cause clefts, aiming to identify families at higher risk. Researchers are also studying tissue engineering approaches that could one day regenerate palate tissue, and testing interventions to support feeding and language development from birth.
Surgical technique refinement
Surgeons are comparing different repair approaches to see which produces better speech and fewer complications. Some studies test whether earlier or later timing of surgery affects long-term outcomes.
Genetic understanding
Researchers are identifying specific genes linked to cleft palate, including variants in IRF6 and other developmental pathways. This knowledge may eventually help predict who needs closer monitoring during pregnancy.
What to know before you search
Eligibility typically depends on the type and severity of the cleft, age at time of repair, and whether other birth differences are present.
What types of trials are currently open
- Surgical technique trials — Comparing different surgical approaches to cleft repair, testing whether modifications improve speech, reduce scarring, or lower the need for follow-up surgeries.
- Speech and feeding trials — Testing therapies and devices to support feeding in infancy and speech development as children grow. Some studies test early intervention programs that start before surgery.
- Genetic studies — Collecting DNA samples from families affected by clefts to identify genetic causes and patterns of inheritance.
- Outcome tracking studies — Following children after cleft repair to understand long-term results — speech quality, hearing, dental development, and quality of life.
- Prevention studies — Testing whether prenatal folic acid or other supplements reduce cleft risk in families with a history of clefts.
Recently added Cleft Palate trials
Receive surgery using a new pain management approach
Orofacial clefts are among the most common congenital malformations, affecting approximately 1 in 700-1500 live births worldwide. They are associated not only with aesthetic concerns but also with functional impairments in feeding, speech, hearing, and dentition, and may be accompanied by other systemic malformations, often requiring multiple surgical procedures and long-term multidisciplinary care. Although cognitive development is preserved, the psychosocial impact on both children and families can be significant. Anesthesia in children with clefts presents specific challenges. Airway management is often more difficult due to anatomical variations, particularly in syndromic patients and those under 1 year of age. Immature organ systems affect drug metabolism, requiring careful dose adjustment. Preoperative anxiety and stress responses are common and may contribute to complications such as laryngospasm and bronchospasm. In the postoperative period, emergence agitation (EA) and emergence delirium (ED) are frequent, with reported incidence up to 80%. These conditions are characterized by restlessness, inconsolability, and disorientation, and may result in self-injury or disruption of surgical repairs. Differentiating agitation from pain is challenging in young children due to limited communication abilities. Validated observational tools such as CHIPPS, PAEDS, and Cravero scales are used for routine clinical assessment of pain and EA/ED, although their subjective nature may limit accuracy. Therefore, evaluation of the perioperative serum cortisol, alpha-amylase, and neuropeptide Y levels will be used. These biomarkers reflect activation of the physiological stress response and indirectly indicate the presence and intensity of pain. Pain management requires a multimodal approach. While opioids remain standard, their use is associated with adverse effects such as respiratory depression, nausea, vomiting, and delayed recovery. Consequently, opioid-free (OF) strategies using different anesthetics, including ketamine and dexmedetomidine have gained attention. This prospective randomized clinical trial will compare opioid-based anesthesia with an opioid-free protocol in children undergoing cleft surgery. A total of 90 patients age of 3 months-7 years will be randomized in a 1:1 ratio. The opioid group will receive fentanyl, while the OF group will receive ketamine and dexmedetomidine; both groups will receive propofol, vecuronium, sevoflurane, and nitrous oxide. Primary outcomes are postoperative pain (CHIPPS) and emergence agitation (PAEDS, Cravero). Pain will be assessed at 5 min, 15 min, 1, 2, 12, and 24 h after extubation, whereas emergence agitation will be evaluated at 5 min, 15 min, 1 h, and 2 h post-extubation. While these scales are routinely used in clinical practice, their subjective nature necessitates additional objective assessment. Therefore, secondary outcomes include evaluation of perioperative stress markers (cortisol, alpha-amylase, neuropeptide Y) and adverse events (nausea, vomiting, pruritus, constipation, respiratory depression, altered consciousness) within 24 h. Procedures will be standardized, with morning surgeries to minimize circadian variations of the biomarkers, performed by the same team. Blood samples will be collected before and after intravenous induction. Postoperative analgesia will include paracetamol and NSAIDs, with fentanyl as rescue therapy. The study hypothesis is that opioid-free anesthesia will provide comparable or superior analgesia, reduce the incidence of emergence agitation, attenuate the stress response, and decrease opioid-related adverse effects, thereby improving overall perioperative safety and recovery in pediatric patients undergoing cleft surgery. The particular value of this study lies in the subgroup of children who will undergo at least two surgical procedures within the observation period. In these patients, each child will be exposed to both anesthetic protocols in separate procedures-once according to the randomly assigned regimen and the second time according to the alternative protocol. In this way, each patient serves as their own control, allowing for a more precise comparison of outcomes with a substantial reduction in inter-individual variability. This approach largely eliminates individual differences such as age, body weight, baseline hemodynamic status, individual sensitivity to anesthetics and analgesics, as well as variability in stress response and pain perception. Such a design enhances the internal validity of the study and enables a more reliable interpretation of the results.
Receive sedation medication for suture removal after cleft surgery
This prospective, randomized study is designed to compare the efficacy and safety of three sedative-analgesic agents-intramuscular ketamine, intranasal nalbuphine, and intranasal dexmedetomidine-for procedural sedation in children undergoing suture removal following cleft palate, alveolar ridge, or lip surgery. The study will include 60 children aged 6 months to 3 years, randomly assigned to one of three intervention groups. The primary objectives are to compare time to achieve adequate sedation (Modified Ramsay Sedation Scale 2-3), surgeon-rated ease of surgical procedure, and time to discharge readiness (Modified Aldrete Score ≥9). Secondary outcomes include baseline child behavior, response to drug administration, depth of sedation, response to separation from parents, and parental satisfaction, as well as monitoring of perioperative complications and vital signs. All study medications are approved and commonly used in pediatric anesthesia. The trial will be conducted using non-invasive monitoring, with intravenous access established only in case of emergency interventions. Findings from this study are expected to provide evidence to optimize pediatric sedation protocols for minor surgical procedures.
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