NCT06114836

GERD Infant Feeding Therapeutics Trial (GIFT Trial)

Pathophysiological Evidence Driven Management of GERD in Neonatal ICU Infants: Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 369 (estimated)
• Sponsor: Nationwide Children's Hospital · Academic / Other
• Sex: All
• Age: 1 Day – 8 Months
• Healthy volunteers: Not accepted

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.

Detailed description

In consented subjects, eligibility is determined after initial diagnostic 24-hour pH Impedance test. These subjects will be randomized to one of the 3 arms of the study (natural maturation, PPI, AR formula) for 4 weeks of treatment. A second 24-hour pH Impedance test will be done on therapy at 4 weeks or before discharge, whichever occurs first. Primary outcome will also be measured at 4 weeks or at discharge, whichever comes first.

Conditions

• GERD in Infants

Interventions

Type	Name	Description
DRUG	Omeprazole	Omeprazole will be the PPI prescribed for 4 weeks.
OTHER	AR formula	Added rice formula will be ordered for 4 weeks.

Timeline

• Start date: 2024-03-14
• Primary completion: 2027-11-01
• Completion: 2028-11-01
• First posted: 2023-11-02
• Last updated: 2024-10-04

Locations

1 site across 1 country: United States