RecruitingNot ApplicableNCT06114836

GERD Infant Feeding Therapeutics Trial (GIFT Trial)

Pathophysiological Evidence Driven Management of GERD in Neonatal ICU Infants: Randomized Controlled Trial


Sponsor

Nationwide Children's Hospital

Enrollment

369 participants

Start Date

Mar 14, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 1 DayMax Age: 8 Months

Inclusion Criteria4

  • 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 Criteria4

  • 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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGOmeprazole

Omeprazole will be the PPI prescribed for 4 weeks.

OTHERAR formula

Added rice formula will be ordered for 4 weeks.


Locations(1)

Nationwide Children's Hospita

Columbus, Ohio, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06114836