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Neonatal Gastro-Esophageal Reflux Disease (GERD) Management Trial (GMT)

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ClinicalTrials.gov Identifier: NCT02486263
Recruitment Status : Recruiting
First Posted : July 1, 2015
Last Update Posted : March 13, 2018
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Ohio State University
Information provided by (Responsible Party):
Sudarshan Jadcherla, Nationwide Children's Hospital

Brief 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.


Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Disease Other: Study Not Applicable

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).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pathophysiology of the Aerodigestive Reflex in Infants: GERD Management Trial
Study Start Date : December 2012
Estimated Primary Completion Date : March 31, 2019
Estimated Study Completion Date : March 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Arm Intervention/treatment
Experimental: Study
Treated with omeprazole. This group of subjects will have prescribed restricted feeding volumes, monitored feeding duration time and positioning restrictions
Other: Study
  • Omeprazole 0.75-1.5 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 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.



Primary Outcome Measures :
  1. 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

  2. Mechanisms of Aerodigestive Safety [ Time Frame: 5 weeks ]
    Mechanisms of aerodigestive clearance and esophageal provocation are evaluated


Secondary Outcome Measures :
  1. 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

  2. Development Outcome Measures [ Time Frame: Up to1 year age ]
    Feeding Milestones: The investigators will track the ability to develop independent feeding skills.

  3. 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.



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Ages Eligible for Study:   34 Weeks to 60 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hospitalized infants with aerodigestive or GERD symptoms
  • Gestational age ≤42 weeks
  • Premature infants are eligible at 34 weeks postmenstrual age (PMA)
  • Enteral or Oral Fed
  • Average daily total feeding volume ≥ 150ml/kg/day
  • Room air or supplemental oxygen of ≤1 liter/minute (LPM) and/or ≤ 35% by nasal cannula

Exclusion Criteria:

  • Known genetic, metabolic or syndromic disease
  • Neurological diseases such as Grade 3 or 4 intraventricular hemorrhage (IVH) or intracranial hemorrhage (ICH) and perinatal asphyxia
  • Gastrointestinal malformations and surgical gastrointestinal conditions

Information from the National Library of Medicine

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


Contacts
Contact: Rebecca K Moore, RNC,BSN 614-355-6635 rebecca.moore@nationwidechildrens.org
Contact: Brittany M Durr, RN, BSN, MHA 614-355-6660 brittany.durr@nationwidechildrens.org

Locations
United States, Ohio
The Research Institute at Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Principal Investigator: Sudarshan R Jadcherla, MD         
Sponsors and Collaborators
Sudarshan Jadcherla
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Ohio State University
Investigators
Principal Investigator: Sudarshan R Jadcherla, MD The Research Institute at Nationwide Children's Hospital

Publications:
Responsible Party: Sudarshan Jadcherla, Principal Investigator, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT02486263     History of Changes
Other Study ID Numbers: 11-00734
R01DK068158 ( U.S. NIH Grant/Contract )
First Posted: July 1, 2015    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Sudarshan Jadcherla, Nationwide Children's Hospital:
infant
esophagitis
neonate
GERD

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action