At a glance
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Pathophysiology of the Aerodigestive Reflex in Infants: GERD Management Trial
In Brief
A clinical study evaluating Study Arm - acid suppression plus feeding bundle and Conventional arm - acid suppression only for Gastroesophageal Reflux Disease. Completed, enrolled 76 participants across 1 site.
Detailed Summary
The overall purpose of the investigator's study is to evaluate the causes of and treatment for feeding difficulty in infants with Gastro-esophageal Reflux Disease (GERD). New treatments can be possible only if the cause is known. Many infants have GERD and feeding difficulties, such as sucking and swallowing problems, vomiting, or delayed emptying of the stomach. Some of these infants have difficulty in protecting their airway during feeding or during reflux, and as a result can breathe fluid into their lungs or hold their breath. Most GERD treatments are done based on experience, but there is no scientific proof that these methods work for infants. GERD and feeding difficulties can lead to longer hospitalization and more stress for the family. In this clinical trial, the investigators are developing new methods to help with diagnosis as well as defining better treatment strategies in relieving GERD and GERD complications.
Study Details
Timeline
Interventions
* Omeprazole 0.5-1.5 milligrams/kilogram/dose twice a day (BID) * Total fluid volume restriction (120-140 milliliters/kilogram/day) * Feeding duration over 30 minutes * Infant feeds with right side down * Infant is placed on back following feeds
-Omeprazole 0.5-1.5 milligrams/kilogram/dose twice a day (BID)