GERD Infant Feeding Therapeutics Trial (GIFT Trial)
ConditionGERD in Infants
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-8
SponsorNationwide Children's Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Omeprazole
DrugOmeprazole will be the PPI prescribed for 4 weeks.
AR formula
Other interventionAdded rice formula will be ordered for 4 weeks.
Treatment groups
369 Participants
are divided into 3 treatment groupsGroup A: Natural maturationNo intervention 0 interventions
Group B: Proton Pump Inhibitor (PPI)Active comparator 1 intervention
Group C: Added Rice (AR) FormulaActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Achievement of primary outcome: Improvement or maintenance of oral feeding and/or absence of GERD symptoms (based on feeding method at inception)
Achievement of the primary outcome will be measured by treatment group to determine efficacy. For subjects on full oral feeds at inception, the primary outcome will be met if there is maintenance of oral feeds AND absence of associated GERD symptoms. For subjects receiving any tube feeding at inception, the primary outcome will be met if there is improvement in oral feeding (ratio of oral to tube feeds) OR absence of troublesome symptoms. The metric for measuring the absence of troublesome symptoms will be vomiting \<2 times/day or coughing \<18 times/day.
Time frame
At 4 weeks of therapy or discharge, whichever occurs first2
Decrease in ARI on treatment
Change in acid reflux index from time one pH impedance study (prior to treatment) to time 2 pH impedance study (during treatment) will be compared among treatment groups.
Time frame
At time 2 study (4 weeks or prior to discharge, whichever is earliest)3
Decreased frequency of GER events on treatment
Change in number of reflux events from time one pH impedance study (prior to treatment) to time 2 pH impedance study (during treatment) will be compared among treatment groups.
Time frame
At time 2 study (4 weeks or prior to discharge, whichever is earliest)4
Improvement (Increase) in distal baseline impedance on treatment
Change in distal baseline impedance from time one pH impedance study (prior to treatment) to time 2 pH impedance study (during treatment) will be compared among treatment groups.
Time frame
At time 2 study (4 weeks or prior to discharge, whichever is earliest)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Nationwide Children's Hospital
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov