Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05455359 · ClinicalTrials.gov registry record · Phase 4
Gastrointestinal Dysmotility on Aspiration Risk
A Phase 4 study of Gastroesophageal Reflux and Aspiration Pneumonia, sponsored by Boston Children's Hospital.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 120
- Enrollment target
- 1
- Study location
NCT05455359: Recruiting Phase 4 study of Gastroesophageal Reflux and Aspiration Pneumonia, sponsored by Boston Children's Hospital.
NCT05455359 is a Phase 4 study of Gastroesophageal Reflux and Aspiration Pneumonia that is actively recruiting participants, run by Boston Children's Hospital. The registered enrollment target is 120 participants, below the 2,883-participant average among 33 other Gastroesophageal Reflux trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05455359, a Phase 4 study of Gastroesophageal Reflux and Aspiration Pneumonia, is actively recruiting participants, sponsored by Boston Children's Hospital.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 120 participants
- Enrollment target
- 1
- Study location
Study Summary
The hypothesis of this study is that esophageal and gastric dysmotility increase the risk of developing aspiration-associated symptoms in children with neurologic impairment. The investigators are conducting a ten week cross over study comparing prucalopride to famotidine for the treatment of aspiration-associated symptoms.
Primary Outcome
Comparison of the mean difference in the Pediatric Cough Quality of Life Questionnaire (range: 7 to 189, lower scores=more symptom impairment) between baseline and 4 week scores between Arm 1 and Arm 2
Conditions Studied
Interventions
- DRUG Famotidine
- DRUG Prucalopride
Study Locations (1)
Massachusetts
- Boston Children's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2025-02-13 |
| Est. Completion | 2027-05-31 |
| Phase | Phase 4 |
What NCT05455359 shows while recruiting
NCT05455359 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 2,883-participant average among 33 other Gastroesophageal Reflux trials with a reported enrollment target (96% lower).
The record links to 4 conditions, with Gastroesophageal Reflux appearing as the primary indexed condition, and to 2 interventions - of which Famotidine is the first listed.
NCT05455359 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05455359 about?
NCT05455359 is a clinical study titled "Gastrointestinal Dysmotility on Aspiration Risk". The hypothesis of this study is that esophageal and gastric dysmotility increase the risk of developing aspiration-associated symptoms in children with neurologic impairment. The investigators are conducting a ten week cross over study comparing prucalopride to famotidine for the treatment of aspira...
What is the current status of trial NCT05455359?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 120 participants. The study started on 2025-02-13. Estimated completion is 2027-05-31.
What conditions does trial NCT05455359 study?
This clinical trial studies the following conditions: Gastroesophageal Reflux, Aspiration Pneumonia, Esophageal Motility Disorders, Gastric Motor Dysfunction.
What interventions are being tested in trial NCT05455359?
The interventions under investigation include: Famotidine (DRUG), Prucalopride (DRUG).
Who is sponsoring clinical trial NCT05455359?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05455359 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Gastroesophageal Reflux
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05455359's enrollment target sits among peer trials
120 15th of 33 higher than 19 of 33 other Gastroesophageal Reflux trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gastroesophageal Reflux trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Esophageal and Laryngeal Tissue Changes in Patients Suspected of Having Laryngopharyngeal Reflux
COMPLETED · Phase 4
-
A Study of Breath Testing for Small Intestinal Bacterial Overgrowth
RECRUITING · NA
-
Transpyloric Versus Gastric Feeding in Bronchopulmonary Dysplasia
RECRUITING · NA
-
Compassionate Use of Domperidone for Refractory Gastroparesis
RECRUITING · NA
-
Barrett's Esophagus Related Neoplasia (BERN) Project
RECRUITING
-
External UES Band (Shaker Pressure Band) and GERD
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01174108 · 120 participants · Phase 2
Allogeneic Hematopoietic Stem Cell Transplantation for Severe Aplastic Anemia and Other Bone Marrow Failure Syndromes Using G-CSF Mobilized CD34+ Selected Hematopoietic Precursor Cells Co-Infused With a Reduced Dose of Non-Mobilized Donor T-cells
- NCT01627301 · 120 participants · NA
Sympathetic Overactivity in Post-traumatic Stress Disorder
- NCT02025023 · 120 participants · Phase 3
Local 5-Fluorouracil Injection for the Treatment of Chalazia: A Prospective, Comparative Study
- NCT02128906 · 120 participants · Phase 2
Radiotherapy With Cisplatin vs. Docetaxel-cetuximab in HNSCC: ERCC1 Biomarker Enrichment and Interaction Design
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI