Actively Recruiting
GERD Infant Feeding Therapeutics Trial (GIFT Trial)
Led by Nationwide Children's Hospital · Updated on 2026-05-05
369
Participants Needed
1
Research Sites
241 weeks
Total Duration
On this page
Sponsors
N
Nationwide Children's Hospital
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
GERD Infant Feeding Therapeutics Trial (GIFT Trial)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- NICU infants of any gestational age who are between 37 - 47 weeks postmenstrual age at inception of the study
- GERD diagnosis using pH-impedance criteria with Acid Reflux Index �3% plus at least one of the following: more than 70 GER events per day, Symptom Associated Probability �5%, or Distal Baseline Impedance less than 900 9
- Full enteral feeds
- No current GERD therapies
You will not qualify if you...
- Known lethal chromosomal abnormalities or complex congenital syndromes
- Severe neurologic pathologies requiring neuroactive medications or neurosurgery
- Positive airway pressure or oxygen flow greater than 4 LPM
- Upper gastrointestinal malformations requiring surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Nationwide Children's Hospita
Columbus, Ohio, United States, 43215
Actively Recruiting
Research Team
E
Erika K Osborn
CONTACT
P
Patty Luzader
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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