GERD Infant Feeding Therapeutics Trial (GIFT Trial)

Conditions

• GERD in Infants

Eligibility Criteria

Sex

ALL

Age

1 Day - 8 Months

Healthy Volunteers

Not accepted

Interventions

• Omeprazole — DRUG
  Omeprazole will be the PPI prescribed for 4 weeks.
• AR formula — OTHER
  Added rice formula will be ordered for 4 weeks.

Study Details

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 Dates

Start date

Mar 14, 2024

Status verified

Apr 2026

Primary completion

Nov 30, 2028

Completion

Nov 30, 2028

Study Design

Enrollment

369 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• No Intervention: Natural maturation
  Allows for time for infant maturation without treatment.
• Active Comparator: Proton Pump Inhibitor (PPI)
  Omeprazole will be prescribed for 4 weeks using the dose of 1.5mg/kg/dose daily.
• Active Comparator: Added Rice (AR) Formula
  Added rice formula will be ordered as the infant diet for the 4-week treatment period.

Primary Outcome Measure

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 ]

Central Contacts

• Erika K Osborn
  6143556667
  [email protected]
• Patty Luzader
  6143556627
  [email protected]

Locations (1)

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