Clinical trial NCT06114836: GERD Infant Feeding Therapeutics Trial (GIFT Trial)
Official title: Pathophysiological Evidence Driven Management of GERD in Neonatal ICU Infants: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: GERD in Infants
Keywords: Proton Pump Inhibitor
pH Impedance
added rice formula
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2023-11-02
Enrollment: 369
Sex: ALL
Minimum age (years): 1
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Infants will be randomized to one of three arms: Natural maturation, Proton Pump Inhibitor (PPI) treatment, or Added rice (AR) formula. Subjects will be stratified and allocated 1:1:1 based on tube feeds (yes or no) and ARI (3-7% or \>7%).
Primary purpose: TREATMENT

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-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.

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 formula) for 4 weeks of treatment. A second 24-hour pH Impedance test will be done on therapy at 4 weeks or before discharge, whichever occurs first. Primary outcome will also be measured at 4 weeks or at discharge, whichever comes first.

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Achievement of primary outcome: Improvement or maintenance of oral feeding and/or absence of GERD symptoms (based on feeding method at inception)
timeFrame: At 4 weeks of therapy or discharge, whichever occurs first
measure: Decrease in ARI on treatment
timeFrame: At time 2 study (4 weeks or prior to discharge, whichever is earliest)
measure: Decreased frequency of GER events on treatment
timeFrame: At time 2 study (4 weeks or prior to discharge, whichever is earliest)
measure: Improvement (Increase) in distal baseline impedance on treatment
timeFrame: At time 2 study (4 weeks or prior to discharge, whichever is earliest)
measure: Decrease in symptom associated probability on treatment
timeFrame: At time 2 study (4 weeks or prior to discharge, whichever is earliest)
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospita
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Sudarshan R sudarshan.jadcherla@nationwidechildrens.org
role: PRINCIPAL_INVESTIGATOR
References: