Neonatal Gastro-Esophageal Reflux Disease (GERD) Management Trial
Completed · Not applicable
Conditions studied: Gastroesophageal Reflux Disease
In brief
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.
Key facts
- Study ID
- NCT02486263
- Run by
- Sudarshan Jadcherla
- People needed
- 76
- Starts
- 2012-12-01
- Expected to finish
- 2020-03-31
- Last updated by the study team
- 2020-07-29
Who can join
Age: 1 and older, up to 1. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- The Research Institute at Nationwide Children's Hospital — Columbus, Ohio, United States
Full record on ClinicalTrials.gov
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