Clinical Research Directory

Premature Infant Oral Motor Intervention vs. Pacifier for Oral Feeding Transition in Preterm Infants

This study compares three approaches to help premature babies learn to feed by mouth: a special mouth exercise program (called PIOMI), using a pacifier, and standard care. Premature babies often have difficulty feeding because their sucking, swallowing, and breathing are not yet coordinated, which can lead to longer hospital stays. The study will include 150 premature infants born between 26 and 32 weeks of pregnancy at a hospital in Thi Qar. Babies will be randomly placed into one of three groups: one group will receive a many-day mouth exercise program, another will use a pacifier for many days, and the third will receive routine care. We will measure how quickly each baby learns to feed fully by mouth, how long they stay in the hospital, how much weight they gain, and their feeding skills. The results may help improve care for premature babies and reduce the time they spend in the hospital.

Review of Infant Oral Feeding and Skills

This study evaluates the infant's feeding skill level at discharge from the neonatal intensive care unit. The goal is to determine whether the ability to "full feed by volume" implies "full skill development" for infant oral feeding.

Parent Tube Weaning Interviews

Recent developments in remote monitoring software can provide a proactive means for data transfer for healthcare teams to communicate with families regarding activities like weaning from feeding tubes. Children's Mercy began utilizing a mHealth technology - CHAMP App® - for tube weaning in the Fall of 2023. Research gaps remain in this population, including comparing the experiences of families who could wean with methods available prior to the innovative use of a medical team collaborating with mHealth technology. This will be a single site study with one-time naturalistic, semi-structured parent interviews of children who have attempted tube weaning in their homes with two different models of care (standard ambulatory tube weaning and with the CHAMP App pilot).

Feeding Difficulties and Quality of Life in Children With Tracheal Cannula

The over all goal of this observational study is to study if there is an association between the presence of feeding difficulties and self-assessed quality of life in children with tracheal cannula. The main questions it aims to answer are 1. What is the incidence of feeding difficulties in children with tracheostomy and what type of feeding difficulties affect these children? 2. How do children with a tracheal tube and their parents assess their quality of life measured through PedsQL? 3. Is there an association between the presence of feeding difficulties and self-assessed quality of life in children with tracheal cannula? Quality of life will be assessed in an interview using the PedsQL instrument generic module 4.0. Swallowing difficulties will be assessed through evaluations based on The Montreal Children's Hospital Feeding Scale.

Long-Term Effect of Online Occupational Therapy-Based Parent Training on Feeding Problems in Infants

This study type is a clinical trial (randomized controlled longitudinal study). The primary purpose is to determine whether an online occupational therapy-based parent training program can prevent or reduce feeding problems, improve parental attitudes, and decrease parenting stress in mothers of infants. The participant population includes female caregivers (mothers) of typically developing infants aged 18 to 24 months. All participants are healthy volunteers. The main research questions this study aims to answer are: Does online occupational therapy-based parent training reduce feeding problems in infants (e.g., food refusal, resistance, sensory-based rejection)? Does the training improve maternal attitudes related to feeding and reduce parenting-related stress? Comparison group: Researchers will compare the outcomes of mothers who receive the online training (intervention group) with those who receive no intervention (control group) to determine the effectiveness of the program. Participants will be asked to: Complete baseline assessment forms prior to randomization If in the intervention group: Attend a 4-week online group training program (one session per week) via a secure Zoom® platform Participate in follow-up assessments at 6 months and 12 months post-training All participants (in both groups) will: Complete standardized assessment tools at three time points (baseline, 6-month follow-up, 12-month follow-up), including: Sociodemographic Information Form Infant Adaptive Feeding Behavior Scale Feeding Process Parental Attitude Scale Parenting Stress Scale

The Use of High Bile-Binding Foods to Reduce Upper Gastrointestinal Bile Acid Concentrations (Aim 3)

Using a longitudinal cohort design, we will compare the impact of a high BA-binding blenderized diet compared to a low BA-binding blenderized diet and an amino acid-based formula, on gastrointestinal and pulmonary hospitalization and emergency room visit rates over six months.

The Use of High Bile-binding Foods to Reduce Upper Gastrointestinal Bile Acid Concentrations (Aim 1)

We will perform an acute physiology study comparing three different diets-an amino acid-based formula, a low bile acid-binding blenderized diet, or a high bile acid-binding blenderized diet administered through gastrostomy tube. We will determine the differences in gastric and salivary bile acid concentrations between participants over the 4 hour post-prandial timeframe. Participants who regularly receive an amino acid-based formula will receive an amino acid-based formula during the study and participants who regularly receive a blenderized feed will receive a blenderized feed during the study. Only participants who regularly receive blenderized feeds will be randomized to receive either the high or low bile acid binding blenderized feed.

The Use of High Bile-binding Foods to Reduce Upper Gastrointestinal Bile Acid Concentrations (Aim 2)

Using a four-week randomized, crossover study design, we will assess the impact of 2 weeks of a high bile acid-binding blenderized diet, compared to 2 weeks of a low bile acid-binding blenderized diet, on gastric and salivary bile acid concentrations within individual participants. Four weeks of an amino acid formula will be a comparator group.

Stereotypic Behaviors and Feeding Difficulties in Adults With Developmental Disabilities

Adults with developmental disabilities (DD) and autism represent a vulnerable demographic that transitions into adulthood with diverse etiologies, exhibiting a significantly higher prevalence of various challenging behaviors. These problematic behaviors can lead to adverse health outcomes and a diminished quality of life. Addressing these issues often necessitates an interdisciplinary approach to continuity of care, focusing on enhancing functional skills, empowerment, and independence, as well as preventing and mitigating challenging behaviors. The current research proposal comprises of three studies designed to evaluate the efficacy of behavioral interventions for problematic behaviors in adults with DD and autism. If left unaddressed, these behaviors may worsen over time, potentially hindering community involvement, educational opportunities, and employment prospects. These include harmful stereotypies and feeding difficulties.