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.
Phase:
N/A
Details
Lead Sponsor:
Nationwide Children's Hospital
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)