Feeding Disorder Neonatal
Conditions
Keywords
Chronic tube feeding, Gastrostomy, Deglutition, Esophageal manometry
Brief summary
The goal of this study is to demonstrate safety, feasibility, and efficacy of a novel pharyngo-esophageal stimulation technique in restoring aerodigestive and swallowing functions in select infants at-risk for chronic gavage tube feeding or gastrostomy. The main aims are: * To provide consistent activation of deglutition (the process of swallowing), swallowing-airway interactions, and peristalsis in order to decrease the risk of home tube feeding. * To examine whether physical and manometric evidence-guided interventions and biofeedback will improve compliance, minimize parental stress, and increase satisfaction and perceived self-confidence with infant feeding. Participants will have weekly pharyngo-esophageal stimulation guided by High Resolution Impedance Manometry (HRIM) for 4 weeks or until discharge, oral nutritive stimulation of at least 5 mL of prescribed milk with each feed, and weekly parental education and feedback regarding feeding progress.
Detailed description
Stimulation will be provided to the esophagus using esophageal manometry starting at enrollment and then weekly for 4 weeks or until discharge, whichever occurs first. During the 4 weeks of study enrollment, subjects will also be provided nutritive oral feeding therapy with each care with a minimum of 5 mL of their prescribed feed. Feeding evaluations by a study team member will occur once a day during the length of the 4-week trial. The study team will do weekly rounds at the bedside to evaluate feeding progress and study interventions. A feeding plan will be posted at the bedside for clear communication with the care team and family of the subjects.
Interventions
PROCEDUREEsophageal stimulation with high resolution esophageal manometry and nutritive oral feeding therapy
Subjects will be given weekly pharyngo-esophageal stimulation guided by high resolution impedance manometry for 4 weeks. During this time of study intervention, every feed will start with nutritive oral stimulation with at least 5 mL of the infant's prescribed diet.
Sponsors
Sudarshan Jadcherla
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Mechanistic study design
Eligibility
Sex/Gender
ALL
Age
1 Days to 8 Months
Healthy volunteers
No
Inclusion criteria
* NICU infant ≥37 weeks postmenstrual age not taking full oral feeds * Consult to Neonatal \& Infant Feeding Disorder Program for oral feeding difficulty with diagnostic manometry ordered * Presence of peristaltic and sphincteric reflexes at initial manometry
Exclusion criteria
* Potentially lethal chromosomal anomalies * Craniofacial malformations * Foregut malformations
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oral feeding volumes prior to and at the completion of the study | Collected at 4 weeks or prior to discharge | Oral feeding volume will be compared prior to the initial manometry study and after the completion of the final manometry study after 4 weeks or prior to discharge, whichever is earliest |
| Parent surveys | 4 weeks or prior to discharge | Parental questionnaires will be compared from prior to initial esophageal manometry study and after completion of final esophageal manometry study. |
Countries
United States
Contacts
CONTACTErika K Osborn
CONTACTPatty Luzader
PRINCIPAL_INVESTIGATORSudarshan Jadcherla
Nationwide Children's Hospital
Outcome results
None listed