GERD Infant Feeding Therapeutics Trial (GIFT Trial)
GIFT
Pathophysiological Evidence Driven Management of GERD in Neonatal ICU Infants: Randomized Controlled Trial
2 other identifiers
interventional
369
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2024
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 26, 2023
CompletedFirst Posted
Study publicly available on registry
November 2, 2023
CompletedStudy Start
First participant enrolled
March 14, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2028
May 5, 2026
April 1, 2026
4.6 years
October 26, 2023
April 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Achievement of primary outcome: Improvement or maintenance of oral feeding and/or absence of GERD symptoms (based on feeding method at inception)
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
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
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
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
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)
Study Arms (3)
Natural maturation
NO INTERVENTIONAllows for time for infant maturation without treatment.
Proton Pump Inhibitor (PPI)
ACTIVE COMPARATOROmeprazole will be prescribed for 4 weeks using the dose of 1.5mg/kg/dose daily.
Added Rice (AR) Formula
ACTIVE COMPARATORAdded rice formula will be ordered as the infant diet for the 4-week treatment period.
Interventions
Omeprazole will be the PPI prescribed for 4 weeks.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nationwide Children's Hospita
Columbus, Ohio, 43215, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sudarshan R sudarshan.jadcherla@nationwidechildrens.org
Nationwide Children's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator, Innovative Feeding Disorders Research Program
Study Record Dates
First Submitted
October 26, 2023
First Posted
November 2, 2023
Study Start
March 14, 2024
Primary Completion (Estimated)
November 1, 2028
Study Completion (Estimated)
November 1, 2028
Last Updated
May 5, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share
Will revisit at a later date