Status:
RECRUITING
GERD Infant Feeding Therapeutics Trial (GIFT Trial)
Lead Sponsor:
Nationwide Children's Hospital
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
GERD in Infants
Eligibility:
All Genders
1-8 years
Phase:
NA
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-Im...
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 fo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 14 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2028
Estimated Enrollment :
369 Patients enrolled
Trial Details
Trial ID
NCT06114836
Start Date
March 14 2024
End Date
November 1 2028
Last Update
October 4 2024
Active Locations (1)
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1
Nationwide Children's Hospita
Columbus, Ohio, United States, 43215