About this trial
The goal of this investigator-initiated, single-center, randomized controlled trial (RCT) is to compare the effects of four weeks of three therapies on clinical and mechanistic outcomes based on pH-Imp testing using a three-arm parallel design in NICU infants with objective GERD diagnosis. The three therapies being compared are natural maturation, proton pump inhibitor (PPI) use, and added rice (AR) formula use. The main goals are:
* to evaluate and compare the efficacy of the three commonly used treatment interventions used in the NICU for GERD in a randomized controlled manner with the primary endpoint of oral feeding success and absence of troublesome symptoms (as defined below). * to characterize the mechanisms of primary end point (success or failure) using pH-Impedance metrics.
Eligibility criteria
Qualifiers
GERD diagnosis using pH-impedance criteria (Acid Reflux Index ≥ 3% plus at least one of the following: # GER events >70 / day, Symptom Associated Probability ≥ 95%, Discal Baseline Impedance < 900 Ω)
Full enteral feeds
No current GERD therapies
Disqualifiers
Known lethal chromosomal abnormalities or complex congenital syndromes
Severe neurologic pathologies requiring neuroactive medications or neurosurgery
Positive airway pressure or oxygen flow > 4 LPM
Upper gastrointestinal malformations requiring surgery
Trial design
Treatments tested in this trial
- Omeprazole
- AR formula
Treatment groups
Sponsors and collaborators
Nationwide Children's Hospital
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator