Comparative Anti-Reflux Procedures in Neurologically Impaired Children

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.