GERD Infant Feeding Therapeutics Trial (GIFT Trial)

Nationwide Children's Hospital

Status: Enrolling

Conditions: GERD in Infants

Treatments: Drug: Omeprazole; Other: AR formula

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06114836

1R01DK136762-01 (U.S. NIH Grant/Contract)

STUDY00003300

Details and patient eligibility

About

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.

Full 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.

Enrollment: 369 estimated patients

Sex: All

Ages: 1 day to 8 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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369 participants in 3 patient groups

Natural maturation

No Intervention group

Description:

Allows for time for infant maturation without treatment.

Proton Pump Inhibitor (PPI)

Active Comparator group

Description:

Omeprazole will be prescribed for 4 weeks using the dose of 1.5mg/kg/dose daily.

Treatment:

Drug: Omeprazole

Added Rice (AR) Formula

Active Comparator group

Description:

Added rice formula will be ordered as the infant diet for the 4-week treatment period.

Treatment:

Other: AR formula