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NCT01307982 · ClinicalTrials.gov registry record · NA
Comparative Anti-Reflux Procedures in Neurologically Impaired Children
A NA study, sponsored by University of Utah.
- Completed
- Registry status
- NA
- Development phase
- 3
- Enrollment target
NCT01307982: Completed NA study, sponsored by University of Utah.
NCT01307982 is a NA study that has completed, run by University of Utah. The registered enrollment target is 3 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01307982, a NA study, has completed, sponsored by University of Utah.
- COMPLETED
- Registry status
- NA
- Development phase
- 3 participants
- Enrollment target
Study Summary
This trial is a randomized controlled trial of two standard anti-reflux procedures, Nissen fundoplication versus gastrojejunal feeding tubes (GJ tubes), in children and adolescents with functional and intellectual impairment who have gastrostomy feeding tubes and medically refractory or severe gastroesophageal reflux disease (GERD). This is a pilot study to establish feasibility before initiating a multi-centered study.
Primary Outcome
Parental interviews and chart reviews will be used to record all health care encounters. Each encounter will be classified as either GERD-related or not. GERD-related hospitalizations and ED visits will be further classified as; diagnostic testing, procedural problems, likely aspiration pneumonia (AP or bacterial pneumonia), respiratory distress of other etiology, or death from any cause.
Interventions
- PROCEDURE Fundoplication
- PROCEDURE Gastrojejunal (GJ) feeding tube
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2011-01 |
| Est. Completion | 2013-09 |
| Phase | NA |
What the finished NCT01307982 record still lists
NCT01307982 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 2 interventions - of which Fundoplication is the first listed.
NCT01307982 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01307982 about?
NCT01307982 is a clinical study titled "Comparative Anti-Reflux Procedures in Neurologically Impaired Children". This trial is a randomized controlled trial of two standard anti-reflux procedures, Nissen fundoplication versus gastrojejunal feeding tubes (GJ tubes), in children and adolescents with functional and intellectual impairment who have gastrostomy feeding tubes and medically refractory or severe gastr...
What is the current status of trial NCT01307982?
This trial is currently completed. It is a NA study. The enrollment target is 3 participants. The study started on 2011-01. Estimated completion is 2013-09.
What interventions are being tested in trial NCT01307982?
The interventions under investigation include: Fundoplication (PROCEDURE), Gastrojejunal (GJ) feeding tube (PROCEDURE).
Who is sponsoring clinical trial NCT01307982?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01307982's enrollment target sits among peer trials
3 1996th of 2000 higher than 4 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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
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