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.