GERD Infant Feeding Therapeutics Trial (GIFT Trial)
Recruiting
N/A
Interventional Study
GERD in Infants
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 1 Day – 8 Months
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 369 (estimated)
- Sponsor
- Nationwide Children's Hospital · Other
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About This 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 (A…
Trial Locations
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Eligibility Criteria
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…
Contacts