GERD Infant Feeding Therapeutics Trial (GIFT Trial)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-8
SponsorNationwide Children's Hospital

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Omeprazole
  • AR formula

Treatment groups

369 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Nationwide Children's Hospital

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator