Neonatal Gastro-Esophageal Reflux Disease (GERD) Management Trial (GMT)
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|ClinicalTrials.gov Identifier: NCT02486263|
Recruitment Status : Active, not recruiting
First Posted : July 1, 2015
Last Update Posted : April 22, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Gastroesophageal Reflux Disease||Other: Study||Not Applicable|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Pathophysiology of the Aerodigestive Reflex in Infants: GERD Management Trial|
|Study Start Date :||December 2012|
|Estimated Primary Completion Date :||March 31, 2020|
|Estimated Study Completion Date :||March 31, 2020|
Treated with omeprazole. This group of subjects will have prescribed restricted feeding volumes, monitored feeding duration time and positioning restrictions
Other Name: Innovative Arm
No Intervention: Conventional
Treated with omeprazole. This group of subjects will receive the current standard treatment for Gastro-esophageal reflux disease (GERD) which includes use of acid suppressive medication with no restrictions of the feeding volume, duration or positioning.
- Feeding Success [ Time Frame: Up to 5 weeks after enrollment ]The primary endpoint is the feeding success defined as achieving asymptomatic oral feeds within 5 weeks
- Mechanisms of Aerodigestive Safety [ Time Frame: 5 weeks ]Mechanisms of aerodigestive clearance and esophageal provocation are evaluated
- Growth Outcome Measures [ Time Frame: Up to1 year age ]Growth: The investigators will measure and track weight, length and head circumference during this time period
- Development Outcome Measures [ Time Frame: Up to1 year age ]Feeding Milestones: The investigators will track the ability to develop independent feeding skills.
- Respiratory Outcome Measures [ Time Frame: Up to1 year age ]Breathing methods: The investigators will track the methods of respiratory support if any during this period.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02486263
|United States, Ohio|
|The Research Institute at Nationwide Children's Hospital|
|Columbus, Ohio, United States, 43205|
|Principal Investigator:||Sudarshan R Jadcherla, MD||The Research Institute at Nationwide Children's Hospital|