GERD Infant Feeding Therapeutics Trial (GIFT Trial)

Official title

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

Overview

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.

Interventions

• Drug Omeprazole
  Omeprazole will be the PPI prescribed for 4 weeks.
• Other AR formula
  Added rice formula will be ordered for 4 weeks.

Primary outcome measures

• Achievement of primary outcome: Improvement or maintenance of oral feeding and/or absence of GERD symptoms (based on feeding method at inception) [Time frame: At 4 weeks of therapy or discharge, whichever occurs first]
• Decrease in ARI on treatment [Time frame: At time 2 study (4 weeks or prior to discharge, whichever is earliest)]
• Decreased frequency of GER events on treatment [Time frame: At time 2 study (4 weeks or prior to discharge, whichever is earliest)]
• Improvement (Increase) in distal baseline impedance on treatment [Time frame: At time 2 study (4 weeks or prior to discharge, whichever is earliest)]
• Decrease in symptom associated probability on treatment [Time frame: At time 2 study (4 weeks or prior to discharge, whichever is earliest)]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Nationwide Children's Hospita — Columbus

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. PMID 42277732

Identifiers

NCT: NCT06114836 · STUDY00003300 · 1R01DK136762-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗