NCT06118697

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
31mo left

Started Feb 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress48%
Feb 2024Nov 2028

First Submitted

Initial submission to the registry

October 26, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 7, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

February 5, 2024

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2028

Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

4.7 years

First QC Date

October 26, 2023

Last Update Submit

April 29, 2026

Conditions

Feeding Disorder Neonatal

Keywords

Chronic tube feedingGastrostomyDeglutitionEsophageal manometry

Outcome Measures

Primary Outcomes (2)

  • 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

    Collected at 4 weeks or prior to discharge

  • Parent surveys

    Parental questionnaires will be compared from prior to initial esophageal manometry study and after completion of final esophageal manometry study.

    4 weeks or prior to discharge

Study Arms (1)

Infants with Complex Feeding Difficulties

EXPERIMENTAL

Weekly manometric esophageal stimulation as well as consistent nutritive oral feeding therapy

Procedure: Esophageal stimulation with high resolution esophageal manometry and nutritive oral feeding therapy

Interventions

Esophageal stimulation with high resolution esophageal manometry and nutritive oral feeding therapyPROCEDURE

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.

Infants with Complex Feeding Difficulties

Eligibility Criteria

Age1 Day - 8 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Potentially lethal chromosomal anomalies
  • Craniofacial malformations
  • Foregut malformations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

RECRUITING

Study Officials

  • Sudarshan Jadcherla

    Nationwide Children's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Erika K Osborn

CONTACT

6143556667erika.osborn@nationwidechildrens.org

Patty Luzader

CONTACT

6143556627patty.luzader@nationwidechildrens.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Mechanistic study design
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator, Innovative Feeding Disorders Research Program

Study Record Dates

First Submitted

October 26, 2023

First Posted

November 7, 2023

Study Start

February 5, 2024

Primary Completion (Estimated)

November 1, 2028

Study Completion (Estimated)

November 1, 2028

Last Updated

May 5, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

will revisit at a later date

Locations

US(1)