Otitis Media Recurrent

The goal of this clinical trial is to learn whether osteopathic manipulative treatment, or OMT, can reduce the need for tympanostomy tube surgery in children with recurrent or chronic otitis media who have been referred to an Ear, Nose, and Throat surgeon and are being considered for tympanostomy tube placement. The main question it aims to answer is: Can a standardized OMT protocol, given once weekly for 4 weeks before the final surgical decision, reduce the rate of tympanostomy tube surgery in pediatric patients with recurrent or chronic otitis media? Researchers will compare children who receive the standardized OMT protocol with children who receive a placebo/control manual treatment protocol to see whether OMT leads to a clinically meaningful reduction in the need for surgery. Participants will: * Attend 4 weekly study visits before their final ENT surgical decision. * Receive one of several assigned combinations of standardized OMT intervention procedures and control manual procedures. Each participant's assigned treatment sequence is determined by randomization. * Complete study-related assessments and questionnaires related to ear symptoms and quality of life. * Continue their planned ENT care, including follow-up evaluation with the ENT surgeon to determine whether tympanostomy tube surgery is still recommended.

This study looks at the safety and performance of the CLiKX device. The device is used to place ear tubes (also called ventilation tubes) in children and adults. These tubes help treat chronic ear fluid (otitis media with effusion) and other conditions where a doctor decides an ear tube is needed. In this study, surgeons will use the CLiKX device to place an ear tube in the patient's ear. The study will check if the surgeon can place the tube correctly in the right position. The procedure will first be attempted with no anesthesia or with local anesthesia. If needed, the surgeon may then use mild sedation or general anesthesia. The study will also look at how well patients tolerate the procedure by checking for side affects during the procedure. Finally, the study will look at how the device affects the procedure and patient safety. Researchers will review how the procedure is performed and will follow patients for up to 30 days after the procedure to continue to check for any side effects..

The 'Standard of Care Plus' ('PLUS') model in the ROOT Study consists of analyzing select micronutrient and gene variants of pregnant females to construct trimester-specific and personalized nutrition and lifestyle recommendations in collaboration with in-person standard obstetric care (SOC). In 2014, the investigators demonstrated statistically significant reductions in adverse maternal and infant outcomes using the 'PLUS' model compared to SOC alone. Further study in a 50% Medicaid Oregon 'PLUS' cohort (N=387) demonstrated association with highly significant risk reductions in all primary outcomes (p-value \<0.001): preterm birth: relative risk (RR) = 0.238 (4.2x less likely), hypertensive disorders of pregnancy: RR = 0.229 (4.4x less likely), gestational diabetes: RR = 0.071 (14x less likely), small for gestational age: RR = 0.252 (4x less likely), and large for gestational age: RR = 0.357 (2.8x less likely). A 100% Medicaid and ethnically diverse Nevada 'PLUS' cohort showed similar trends in all outcomes that were not statistically significant because of small sample size. Structured as a prospective interventional study, the study evaluates whether the 'PLUS' model can achieve similar outcome improvements within the Novant Health (NH) system in North Carolina. The study will assess both clinical outcomes and digital nutrition platform performance within the existing healthcare infrastructure. The primary hypothesis of the ROOT study is that collaborative implementation of the 'PLUS' nutritional care model at NH Triad Obstetrics/Gynecology (OB/GYN) Clinic will be associated with reduced maternal and infant adverse outcome rates when compared to historical regional and NH system outcomes in those who received SOC alone. The secondary hypothesis of the ROOT Study is that the 'PLUS' model applied during pregnancy will be associated with reduced pediatric adverse outcomes. The 'PLUS' offspring that remain in the NH system will be observed longitudinally over 5 years with chart review at birth through 2 weeks of age, and at 1, 3, and 5 years of life. The outcomes assessed include neonatal intensive care unit (NICU) admission in the first two weeks of life, atopic dermatitis, eczema, asthma, allergies, otitis media, obesity, and autism. The 'PLUS' adverse outcome rates will be compared to adverse outcome rates in children born regionally and nationally under SOC alone. Participant compliance with the 'PLUS' model, and participant and nutritionist access to the digital health platform will be studied during each trimester of use, as well as in the postpartum time period. The exploratory hypothesis is that the digital platform will not affect access, compliance, and rates of maternal and neonatal adverse outcomes.