Clinical Research Directory

Speech Intervention Via Telepractice for Children With Repaired Cleft Palate

The goal of this interventional study is to see if online speech therapy works just as well as face-to-face speech therapy in children with cleft palate. The main purposes are: To compare the speech accuracy of target sounds in words produced by children with cleft palate between online and face-to-face speech therapy. To compare the gain in speech accuracy in sentences produced by children with cleft palate between online and face-to-face speech therapy. To assess whether changes in speech intelligibility are perceived by parents. To explore what kinds of factors influence speech accuracy. To explore speech training accuracy and speech understandability training accuracy during speech therapy sessions in children with CP Participants will participate in 30-minute speech intervention sessions twice a week for 10 weeks, either in-person or online.

Length of Hospital Stay and Postoperative Analgesic Requirements After Introduction of a Specific Maxillary Nerve Block in Children Undergoing Cleft Palate Surgery

Cleft lip and palate (CLP) is one of the most common congenital malformations and requires repeated surgical correction during childhood. Surgical repair is often associated with significant postoperative pain, traditionally managed with morphine, which carries a risk of undesirable side effects. The suprazygomatic maxillary nerve block (SZMNB) has been shown to provide effective analgesia and may reduce the need for opioids. Routine use of SZMNB was introduced at the pediatric surgery unit at Karolinska University Hospital in late 2017. A before-and-after evaluation project based on retrospective chart review was initiated in 2018 but was not completed due to the COVID-19 pandemic. The aim of this project is to investigate whether the introduction of SZMNB has reduced postoperative morphine requirements and opioid-related side effects, and whether this has resulted in shorter hospital stays (earlier discharge) after cleft palate repair.

Early Intervention in Infants With Unrepaired Cleft Palate: Language, Palatal Function, and Articulation.

The goal of this clinical trial is to learn if teaching speech skills to infants with cleft palates, prior to palate repair, will help them to develop speech and language skills. It will also learn about whether the skills are linked to fewer speech sound difficulties when they start school. The main questions it aims to answer are: Do standard, early intervention techniques to promote language development, that are used in children who are late talkers, work in infants with cleft palates? Will infants with cleft palates increase the number of sounds they use after targeted intervention? Can infants attempt to make stop sounds, like b and p, after targeted intervention? Can infants with cleft palate learn new words more quickly when they are used with gestures? Participants will: Participate in a baseline evaluation of speech and language skills, either in person, or via Telehealth. Attend the clinic for twice-weekly visits, for six weeks, to learn techniques to help their infants develop their speech and language skills, in a group setting with other families of infants with cleft palate. Participate in a final evaluation of speech and language skills, either in person, or via Telehealth.

Suprazygomatic Maxillary Nerve Block in Cleft Palate Outcomes

Increased pain after cleft palate surgery is the leading cause of increased hospital length of stay, delayed oral intake, readmission, and respiratory compromise. The goal is to improve all outcomes by identifying the most effective evidenced-based method of intra-operative pain control.

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

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.

Respiratory Tract Microbiome and Probiotics in Children With Cleft Palate

Otitis media with effusion (OME) involves fluid accumulation in the middle ear without infection, sometimes causing discomfort and hearing loss in children. Persistent middle ear fluid lasting over 3 months may require treatment, including placement of ventilation tubes if it affects hearing. Children with a cleft palate are at higher risk for otorrea after ventilation tube placement. Treatment typically involves antibiotic drops and ear cleaning by an ENT doctor, often requiring repeated visits, which may impact quality of life for both the child and the parents. The mouth, throat, and nose harbor bacteria that can influence ear infections. This study aims to determine if probiotics can alter the bacteria in the nasopharynx and middle ear fluid and reduce the number of episodes of eardischarge following ventilation tube placement in children with cleft palate. Using Lacticaseibacillus rhamnosus GG and Bifidobacterium lactis BB-12 from Bactiol® Baby (Metagenics), patients will be divided into two groups: one receiving probiotic drops and one not. The study will assess if probiotics can reduce the number of episodes with ear discharge in children with cleft palate, by examining the following: 1. The airway microbiome composition in children with cleft palates. 2. Whether oral probiotics can reduce the number and duration of ear discharge episodes.

Effect of Infant Sign Training on Speech-language Development

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.

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

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.