Recruiting

GERD Infant Feeding

Sponsor:

Nationwide Children's Hospital

Code:

NCT06114836

Conditions

GERD in Infants

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Omeprazole

AR formula

Study Details

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.

Conditions

GERD in Infants

Study ID

NCT06114836

Start date

Mar 14, 2024

Status verified date

Jun, 2026

Completion date

Nov 1, 2028

Anticipated

Primary completion date

Nov 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

369 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Natural maturation

Allows for time for infant maturation without treatment.

active comparator: Proton Pump Inhibitor (PPI)

Omeprazole will be prescribed for 4 weeks using the dose of 1.5mg/kg/dose daily.

active comparator: Added Rice (AR) Formula

Added rice formula will be ordered as the infant diet for the 4-week treatment period.

Interventions

Omeprazole

Omeprazole will be the PPI prescribed for 4 weeks.

AR formula

Added rice formula will be ordered for 4 weeks.

Primary outcome measure

  • Achievement of primary outcome: Improvement or maintenance of oral feeding and/or absence of GERD symptoms (based on feeding method at inception) [ Time Frame: At 4 weeks of therapy or discharge, whichever occurs first ]
  • Decrease in ARI on treatment [ Time Frame: At time 2 study (4 weeks or prior to discharge, whichever is earliest) ]
  • Decreased frequency of GER events on treatment [ Time Frame: At time 2 study (4 weeks or prior to discharge, whichever is earliest) ]
  • Improvement (Increase) in distal baseline impedance on treatment [ Time Frame: At time 2 study (4 weeks or prior to discharge, whichever is earliest) ]
  • Decrease in symptom associated probability on treatment [ Time Frame: At time 2 study (4 weeks or prior to discharge, whichever is earliest) ]

Central Contacts and Locations

Central contacts

Erika K Osborn

6143556667erika.osborn@nationwidechildrens.org

Patty Luzader

6143556627patty.luzader@nationwidechildrens.org

Locations

Nationwide Children's Hospita

Recruiting

Columbus, Ohio, United States, 43215

Contacts

Erika K Osborn

6143556667erika.osborn@nationwidechildrens.org

More Information

Sponsor

Nationwide Children's Hospital

Last update posted

Jun 23, 2026

Last verified

Jun, 2026

Keywords

  • Proton Pump Inhibitor
  • pH Impedance
  • added rice formula

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Nationwide Children's Hospital on 2026-06-23.