RecruitingNot ApplicableNCT06114836

GERD Infant Feeding Therapeutics Trial (GIFT Trial)

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


Sponsor

Nationwide Children's Hospital

Enrollment

369 participants

Start Date

Mar 14, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 1 DayMax Age: 8 Months

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying AR formula and a drug called Omeprazole for people with gerd in infants. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOmeprazole

Omeprazole will be the PPI prescribed for 4 weeks.

OTHERAR formula

Added rice formula will be ordered for 4 weeks.


Locations(1)

Nationwide Children's Hospita

Columbus, Ohio, United States

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NCT06114836