GERD Infant Feeding Therapeutics Trial (GIFT Trial)

Recruiting now · Not applicable

Conditions studied: GERD in Infants

In brief

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.

Key facts

Study ID

NCT06114836

Run by

Nationwide Children's Hospital

People needed

369

Starts

2024-03-14

Expected to finish

2028-11-01

Last updated by the study team

2026-06-23

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• NICU infants of any gestational age who are between 37 - 47 weeks postmenstrual age at inception of the study meeting the following requirements:
• GERD diagnosis using pH-impedance criteria (Acid Reflux Index ≥ 3% plus at least one of the following: # GER events >70 / day, Symptom Associated Probability ≥ 95%, Discal Baseline Impedance < 900 Ω)
• Full enteral feeds
• No current GERD therapies

You may not qualify if…

• Known lethal chromosomal abnormalities or complex congenital syndromes
• Severe neurologic pathologies requiring neuroactive medications or neurosurgery
• Positive airway pressure or oxygen flow > 4 LPM
• Upper gastrointestinal malformations requiring surgery

Where it is running

• Nationwide Children's Hospita — Columbus, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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