6 Clinical Trials for Various Conditions
The overall objective of this proposal is to test an interdisciplinary intervention to support the transition to oral feeding for children with feeding tubes and tracheostomies. The investigators' model which combines in-home clinical assessments with virtual therapies may maximize the impact of expert interventionists. The investigators' central hypothesis is that children with feeding tubes and tracheostomies will have greater success than a control group when enrolled in a hybrid in-person/virtual intervention including: (1) a coordinated feeding team with an occupational therapist, speech/language pathologist, and registered dietitian; (2) family liaison study coordinators who are poised to support the family through personal experience; (3) a project leader who is a Developmental Behavioral Pediatrician with expertise in children with tracheostomies. The overall objective of this proposal is to test this intervention to increase oral feeding in children with feeding tubes and tracheostomies. To pursue this objective, the investigators propose the following aims: Specific Aim 1: Children enrolled in the intervention group will have improved caregiver self-efficacy and reduced worry related to feeding as determined by The Feeding and Swallowing Impact Survey at the end of a 1-year intervention. Specific Aim 2: Children enrolled in the intervention group will have increased oral vs. tube-fed calories and reduced dependence on feeding tubes as determined by detailed dietary histories and The Children's Eating and Drinking Activity Scale (CEDAS) at the end of a 1-year intervention. The investigators' intervention will determine if a tertiary center of expertise can use a combination of home assessments and virtual interventions to address critical feeding needs for children with tracheostomies. Future clinicians could refer patients to the investigators' center instead of relying on community therapists, who rarely exist. The weekly feeding group sessions as well as the administration of the therapies in a virtual format are research-related. While the therapy techniques implemented during the study are standard of care and within the practice parameters of the practitioners involved, the use of them in a virtual format are novel and should be considered research-related.
This repository will consist of home monitoring data, videos, and images of patients with feeding difficulties for asynchronous remote patient monitoring of manually entered data sent by parents to the healthcare team using the CHAMP App for children with feeding difficulties. This information will be collected under a research protocol and this repository is for future research applications.
Conservative estimates show that 3-5% of all infants have tongue tie. These studies only focus on visible, anterior tongue tie. Deeper, more visibly subtle cases of ankyloglossia have not been included in these incidence numbers, so the percentage of children with ankyloglossia is much higher than previously thought. Previous research by the investigators demonstrates that posterior tongue tie can be as problematic as anterior ties. An available FDA-approved feeding solution allows for the measurement of infant sucking motions. This allows for detection of changes following surgical intervention. Previous ultrasound studies show the importance of the upward movement of the tongue, but further lingual movement parameters following frenotomy have not been reported. The primary goal of this study is to record changes in lingual movement following lingual frenotomy. The investigators plan to compare improvements over time between a control, non-intervention group and a frenotomy group. Secondary goals include recording validated outcomes of reflux and feeding efficiency.
This study will examine the feasibility and preliminary effects of the Mealtime PREP (Promoting Routines of Exploration and Play) intervention package for young children with Sensory Food Aversions and their parents.
This observational study aims to evaluate the psychometric properties of a new infant feeding tool called "SMART Tool" in the neonatal intensive care unit. The main questions it aims to answer are: 1. To design a feeding tool to assess oral motor and neurobehavioral skills in neonates 2. To establish psychometrics of the new tool by doing reliability and validity tests.
This is a multi-center, randomized, placebo-controlled, double-blind clinical trial. The primary focus of the study is the evaluation of the effectiveness of treatment with megestrol as part of a 24 week behavioral feeding protocol in transitioning from tube to oral feedings in a pediatric population. Approximately 60 pediatric subjects matching the criteria for eligibility will be enrolled in the study and randomized to receive either megestrol (n=30) or placebo (n=30).