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.
Age range
1 Day – 8 Months
Sex
ALL
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A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
Decrease in ARI on treatment
Timeframe: At time 2 study (4 weeks or prior to discharge, whichever is earliest)
Decreased frequency of GER events on treatment
Timeframe: At time 2 study (4 weeks or prior to discharge, whichever is earliest)
Improvement (Increase) in distal baseline impedance on treatment
Timeframe: At time 2 study (4 weeks or prior to discharge, whichever is earliest)
Decrease in symptom associated probability on treatment
Timeframe: At time 2 study (4 weeks or prior to discharge, whichever is earliest)