NCT02486263

Neonatal Gastro-Esophageal Reflux Disease (GERD) Management Trial

Pathophysiology of the Aerodigestive Reflex in Infants: GERD Management Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Sudarshan Jadcherla · Academic / Other
• Sex: All
• Age: 34 Weeks – 60 Weeks
• Healthy volunteers: Not accepted

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.

Detailed description

Gastroesophageal reflux disease (GERD) and its troublesome complications constitute serious diagnostic and management challenges to the development of safe feeding and airway protection strategies among infants convalescing in the neonatal intensive care units; thus contributing to prolonged lengths of stay, recurrent hospitalizations, and death. GERD is frequently diagnosed by inadequate criteria, and the relative risks, benefits and indications of GERD therapies are unclear. Significant gaps in knowledge exist in understanding the complex causal or adaptive aerodigestive protective reflex mechanisms implicated in GERD in infants. The long-term goal is to improve digestive health, nutrition, and infant development through the design of simplified personalized treatment paradigms by better understanding the pathophysiology of aerodigestive reflexes. The current objective is to conduct a prospective single center randomized blinded controlled trial comparing the short term effects of the investigators innovative feeding strategy bundle (study approach) versus standard feeding approach (conventional approach).

Conditions

• Gastroesophageal Reflux Disease

Interventions

Type	Name	Description
OTHER	Study Arm - acid suppression plus feeding bundle	* 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
OTHER	Conventional arm - acid suppression only	-Omeprazole 0.5-1.5 milligrams/kilogram/dose twice a day (BID)

Timeline

• Start date: 2012-12-01
• Primary completion: 2020-03-31
• Completion: 2020-03-31
• First posted: 2015-07-01
• Last updated: 2020-07-29
• Results posted: 2020-07-29

Locations

1 site across 1 country: United States