GERD Infant Feeding Therapeutics Trial (GIFT Trial) (GIFT)

April 29, 2026 updated by: Sudarshan Jadcherla, Nationwide Children's Hospital

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

369

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Omeprazole
Omeprazole will be the PPI prescribed for 4 weeks.
Other Names:
  • PPI
Active Comparator: Added Rice (AR) Formula
Added rice formula will be ordered as the infant diet for the 4-week treatment period.
Other: AR formula
Added rice formula will be ordered for 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Achievement of the primary outcome will be measured by treatment group to determine efficacy. For subjects on full oral feeds at inception, the primary outcome will be met if there is maintenance of oral feeds AND absence of associated GERD symptoms. For subjects receiving any tube feeding at inception, the primary outcome will be met if there is improvement in oral feeding (ratio of oral to tube feeds) OR absence of troublesome symptoms. The metric for measuring the absence of troublesome symptoms will be vomiting <2 times/day or coughing <18 times/day.
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)
Change in acid reflux index from time one pH impedance study (prior to treatment) to time 2 pH impedance study (during treatment) will be compared among treatment groups.
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)
Change in number of reflux events from time one pH impedance study (prior to treatment) to time 2 pH impedance study (during treatment) will be compared among treatment groups.
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)
Change in distal baseline impedance from time one pH impedance study (prior to treatment) to time 2 pH impedance study (during treatment) will be compared among treatment groups.
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)
Change in symptom associated probability from time one pH impedance study (prior to treatment) to time 2 pH impedance study (during treatment) will be compared among treatment groups.
At time 2 study (4 weeks or prior to discharge, whichever is earliest)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nationwide Children's Hospital

Collaborators

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

Investigators

  • Principal Investigator: Sudarshan R sudarshan.jadcherla@nationwidechildrens.org, Nationwide Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 14, 2024

Primary Completion (Estimated)

November 1, 2028

Study Completion (Estimated)

November 1, 2028

Study Registration Dates

First Submitted

October 26, 2023

First Submitted That Met QC Criteria

November 1, 2023

First Posted (Actual)

November 2, 2023

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00003300
  • 1R01DK136762-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Will revisit at a later date

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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