GERD Infant Feeding Therapeutics Trial (GIFT Trial)

Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2023
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.
Epistemonikos ID: 9eeb1d91879c3d9c084dc8a2a57fe45b494645ae
First added on: May 15, 2024