Nationwide Children's Hospita
Columbus, Ohio, 43215, United States
Location status: Recruiting
Recruiting
NCT Number: NCT06114836
GERD Infant Feeding Therapeutics Trial (GIFT 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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
1 day–8 month
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Omeprazole
DrugOmeprazole will be the PPI prescribed for 4 weeks.
Other names: PPI
AR formula
OtherAdded rice formula will be ordered for 4 weeks.
Primary outcomes
-
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
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.
-
Decrease in ARI on treatment
Time frame: At time 2 study (4 weeks or prior to discharge, whichever is earliest)
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.
-
Decreased frequency of GER events on treatment
Time frame: At time 2 study (4 weeks or prior to discharge, whichever is earliest)
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.
-
Improvement (Increase) in distal baseline impedance on treatment
Time frame: At time 2 study (4 weeks or prior to discharge, whichever is earliest)
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.
-
Decrease in symptom associated probability on treatment
Time frame: At time 2 study (4 weeks or prior to discharge, whichever is earliest)
Change in symptom associated probability from time one pH impedance study (prior to treatment) to time 2 pH impedance study (during treatment) will be compared among treatment groups.
Study contacts
Contact information is provided by the study sponsor or research team.
Erika K Osborn
CONTACT
Patty Luzader
CONTACT
Sponsors and collaborators
Lead sponsor
Nationwide Children's Hospital
Other
Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Registry information
Official study title
Pathophysiological Evidence Driven Management of GERD in Neonatal ICU Infants: Randomized Controlled Trial
Acronym: GIFT
Important dates
- Study start
- 2024
- Primary completion
- 2028
- Study completion
- 2028
- First posted
- Nov 2, 2023
- Registry last updated
- Jun 23, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.