Neonatal Gastro-Esophageal Reflux Disease (GERD) Management Trial
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Gastroesophageal Reflux Disease |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 1/23/2019 |
| Start Date: | December 2012 |
| End Date: | March 31, 2019 |
Pathophysiology of the Aerodigestive Reflex in Infants: GERD Management Trial
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.
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.
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).
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).
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
We found this trial at
1
site
Columbus, Ohio 43205
Principal Investigator: Sudarshan R Jadcherla, MD
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