GERD Infant Feeding Therapeutics Trial (GIFT Trial)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

369 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-14

Study Completion Date

2028-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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GERD in Infants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Infants will be randomized to one of three arms: Natural maturation, Proton Pump Inhibitor (PPI) treatment, or Added rice (AR) formula. Subjects will be stratified and allocated 1:1:1 based on tube feeds (yes or no) and ARI (3-7% or \>7%).

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Natural maturation

Allows for time for infant maturation without treatment.

Group Type NO_INTERVENTION

No interventions assigned to this group

Proton Pump Inhibitor (PPI)

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

Group Type ACTIVE_COMPARATOR

Omeprazole

Intervention Type DRUG

Omeprazole will be the PPI prescribed for 4 weeks.

Added Rice (AR) Formula

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

Group Type ACTIVE_COMPARATOR

AR formula

Intervention Type OTHER

Added rice formula will be ordered for 4 weeks.

Interventions

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Omeprazole

Omeprazole will be the PPI prescribed for 4 weeks.

Intervention Type DRUG

AR formula

Added rice formula will be ordered for 4 weeks.

Intervention Type OTHER

Other Intervention Names

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PPI

Eligibility Criteria

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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

Minimum Eligible Age

1 Day

Maximum Eligible Age

8 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No