Neonatal Gastro-Esophageal Reflux Disease (GERD) Management Trial (GMT)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02486263 |
|
Recruitment Status :
Completed
First Posted : July 1, 2015
Results First Posted : July 29, 2020
Last Update Posted : July 29, 2020
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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 Arm - acid suppression plus feeding bundle Other: Conventional arm - acid suppression only | 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) |
| Actual Enrollment : | 76 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Pathophysiology of the Aerodigestive Reflex in Infants: GERD Management Trial |
| Study Start Date : | December 2012 |
| Actual Primary Completion Date : | March 31, 2020 |
| Actual Study Completion Date : | March 31, 2020 |
| 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 Arm - acid suppression plus feeding bundle
|
|
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.
|
Other: Conventional arm - acid suppression only
-Omeprazole 0.5-1.5 milligrams/kilogram/dose twice a day (BID) |
- CLINICAL OUTCOME OF FEEDING SUCCESS [ Time Frame: Up to 5 weeks after enrollment ]The primary endpoint is the feeding success defined as achieving full oral feeds (defined as no need for tube feeds to maintain hydration and nutrition) and/or a >/= 6 point decrease from baseline symptom score as described by the Infant-Gastro-Esophageal Reflux Questionnaire-Revised. The minimum score is 0 (no symptoms) and the maximum score is 42 (maximum symptoms). Any total score greater than or equal to 16 is considered abnormal.
- MOTILITY OUTCOMES: Presence of Esophageal Peristaltic Reflexes [ Time Frame: 5 weeks ]This is part of Aim 2 of this RCT, which is a mechanistic outcome designed to understand the reasons for the clinical outcome. Presence of peristaltic reflex mechanisms elicited upon esophageal provocation during esophageal manometry were compared within the groups, week-5 vs. week-0. Odds ratios (ORs) with 95% confidence interval (CI) are reported from Generalized Estimation Equation models.
- CLINICAL OUTCOMES: Growth Outcome Measure [ Time Frame: at 5 weeks ]Growth: The investigators will measure and track weight growth velocity during the study period
- CLINICAL OUTCOME: Development Outcome Measures [ Time Frame: Up to 1 year age ]Feeding Milestones: The investigators will track feeding method at 1 year.
- CLINICAL OUTCOME: Respiratory Outcome Measures [ Time Frame: at discharge ]Supplemental oxygen requirement at discharge was recorded for both groups
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 34 Weeks to 60 Weeks (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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 |
Documents provided by Sudarshan Jadcherla, Nationwide Children's Hospital:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Sudarshan Jadcherla, Principal Investigator, Nationwide Children's Hospital |
| ClinicalTrials.gov Identifier: | NCT02486263 |
| Other Study ID Numbers: |
11-00734 R01DK068158 ( U.S. NIH Grant/Contract ) |
| First Posted: | July 1, 2015 Key Record Dates |
| Results First Posted: | July 29, 2020 |
| Last Update Posted: | July 29, 2020 |
| Last Verified: | July 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
|
infant esophagitis neonate GERD |
|
Gastroesophageal Reflux Esophageal Motility Disorders Deglutition Disorders |
Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases |