GERD Infant Feeding Therapeutics Trial (GIFT Trial)

Description

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

GERD in Infants

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

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

GERD Infant Feeding Therapeutics Trial (GIFT Trial)

Condition
GERD in Infants
Intervention / Treatment

-

Contacts and Locations

Columbus

Nationwide Children's Hospita, Columbus, Ohio, United States, 43215

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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, Symptom Associated Probability ≥ 95%, Discal Baseline Impedance \< 900 Ω)
  • * Full enteral feeds
  • * No current GERD therapies
  • * 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

Ages Eligible for Study

1 Day to 8 Months

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Nationwide Children's Hospital,

Sudarshan R sudarshan.jadcherla@nationwidechildrens.org, PRINCIPAL_INVESTIGATOR, Nationwide Children's Hospital

Study Record Dates

2028-11