GERD Infant Feeding Therapeutics Trial (GIFT Trial)

• Status: Not yet recruiting
• Trial end date: 2028-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nationwide Children's Hospital
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Omeprazole

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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