Feasibility of Aerodigestive Stimulation Therapy Trial
ConditionFeeding Disorder Neonatal
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-8
SponsorSudarshan Jadcherla
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Potentially lethal chromosomal anomalies
Craniofacial malformations
Foregut malformations
Trial design
Design model
Single group
Treatments tested in this trial
Esophageal stimulation with high resolution esophageal manometry and nutritive oral feeding therapy
Procedure/SurgerySubjects 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.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Infants with Complex Feeding DifficultiesExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Oral feeding volumes prior to and at the completion of the study
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
Time frame
Collected at 4 weeks or prior to discharge2
Parent surveys
Parental questionnaires will be compared from prior to initial esophageal manometry study and after completion of final esophageal manometry study.
Time frame
4 weeks or prior to dischargeSponsors and contacts
Click on the lead sponsor to view all of their trials.
Sudarshan Jadcherla
Lead sponsor
Nationwide Children's Hospital
Sponsor institution
Source ClinicalTrials.gov