View Clinical Trial (Medical Research Study)
Comparative Anti-Reflux Procedures in Neurologically Impaired Children
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Salt Lake City |
| State: |
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Utah |
| Zip Code: |
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84113 |
| Conditions: |
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Gastroesophageal Reflux - Nervous System Diseases - Fundoplication - Enteral Nutrition |
| Purpose: |
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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.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
- patient is between 6 months and 18 years of age; AND
- patient has functional impairment classified by either gross motor functional
classification of 3, 4 or 5 OR impaired function in walking, crawling/standing,
rolling/sitting, arm use, hand use, ability to hold head up; AND
- patient has a gastrostomy; AND
- patient has intolerance of feedings or other complications attributed to GERD as
defined below; AND
- patient has a positive GERD diagnostic evaluation as define below:
- GERD diagnostic evaluation will include the following investigations;
- endoscopy and biopsy for visual assessment and histology of the esophageal
mucosa
- pH study and/or multichannel intraluminal impedance (MII) probe to detect
and quantify gastroesophageal reflux
- GER demonstrated by:
- Reflux Esophagitis: Endoscopic appearance of mucosal breaks in the distal
esophagus with or without pathologist diagnosis based on one or more biopsy
histologic features of: inflammatory cellular infiltrate, basal cell
hyperplasia, elongation of the vascular papillae AND no infectious
microorganisms and < 15 eosinophils per high power field; OR
- pH OR pH/multichannel intraluminal impedance(MII) probe evidence of
pathologic GER:
- pH probe: acid reflux index > 7 % OR
- pH/MII reflux symptom-associated acid or non-acid volume associated
reflux events;
- Upper GI will only be used to determine normal anatomy; AND
- patient has either medically refractory GERD or severe GERD as defined below:
- Medically refractory GERD - GERD that has not responded to 12 weeks of
treatment with a proton pump inhibitor (PPI) (and verified gastric pH > 4)
and/or trial of continuous intragastric feedings and has one of the following
complications:
- Esophagitis: Endoscopic appearance of mucosal breaks in the distal
esophagus with or without pathologist diagnosis based on one or more biopsy
histologic features of: inflammatory cellular infiltrate, basal cell
hyperplasia, elongation of the vascular papillae
- Failure to thrive: diminishing weight percentile for age or weight for age
z-score sustained over 6 months.
- Pneumonia consistent with aspiration,
- Acute life threatening event,
- Severe GERD - at least one severe complication of GERD and patient cannot safely
tolerate a trial of medical management due to one of the following
life-threatening complications:
- aspiration pneumonia,
- acute life threatening event (ALTE),
- complete loss of airway protection (absent cough/gag) AND,
- Upper GI barium contrast study for anatomy; AND
- Barium pharyngeal swallow study or modified barium swallow study or Flexible
Endoscopic Evaluation of Swallowing (FEES) in past year; AND
- the parent or legal guardian speaks English or Spanish (the only two languages in
which the instruments are standardized)
Exclusion Criteria:
- Upper GI findings that would mandate a fundoplication including: hiatal hernia,
esophageal stricture, Barret's esophagus; OR
- Upper GI findings show uncorrected distal gastrointestinal obstruction including:
gastric outlet obstruction, duodenal obstruction, malrotation; OR
- Upper GI demonstrates structural foregut abnormalities that preclude a fundoplication
including: microgastria, short esophagus, high anesthetic risk; OR
- Diagnosis or history of congenital diaphragmatic hernia, esophageal atresia, chronic
intestinal pseudoobstruction; OR
- Endoscopy and biopsy demonstrates esophagitis from causes other than GER including:
eosinophilic esophagitis, candida esophagitis, viral esophagitis); OR
- Rapidly changing or indeterminate neurological including either a deteriorating
neurological condition such as rapid loss of developmental milestones or improving,
such as rapid recovery following severe neurological insult; OR
- Patient has unacceptable general anesthetic risk; OR
- A previous Nissen fundoplication; OR
- Feeds delivered by GJ/NJ at the time of enrollment occurring for greater than 3
months.
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| NCT ID: |
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NCT01307982 |
| Primary Contact: |
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Principal Investigator
Raj Srivastava, MD, MPH
University of Utah
Chelsea Welch, B.S.
Phone: 801-662-3670
Email: chelsea.welch@hsc.utah.edu
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| Backup Contact: |
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Email: raj.srivastava@hsc.utah.edu
Raj Srivastava, MD, MPH
Phone: 801-662-3659
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| Location Contact: |
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Salt Lake City, Utah 84113
United States
Chelsea Welch, B.S.
Phone: 801-662-3670
Email: chelsea.welch@hsc.utah.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 22, 2013 |
| Modifications to this listing: |
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