GERD Infant Feeding Therapeutics Trial (GIFT Trial)

Summary

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.

Timeline

Start

2024-03-14

Primary completion

2028-11-01

Completion

2028-11-01

Publications

• Jadcherla SR, Osborn EK, Sultana Z, Helmick R, Sanchez JB, Slaughter JL, Wei L, Di Lorenzo C. GERD management in neonatal ICU infants: study protocol for a randomized controlled trial comparing maturation, added rice starch formula and proton pump inhibitors. BMC Pediatr. 2026 Jun 11. doi: 10.1186/s12887-026-07120-x. Online ahead of print.

Drugs

Indications