GIFT Trial for GERD in Infants
This study, called the GERD Infant Feeding Therapeutics (GIFT) Trial, is looking at ways to help infants in the NICU (Neonatal Intensive Care Unit) who have GERD (Gastroesophageal Reflux Disease). Researchers want to compare three approaches: natural maturation (letting the condition improve on its own), using omeprazole (a proton pump inhibitor, or PPI, which reduces stomach acid), or using added rice (AR) formula. The goal is to see which approach is most effective at improving or maintaining oral feeding and reducing GERD symptoms. To join, infants must be between 1 day and 8 months old, in the NICU, and have a GERD diagnosis confirmed by a special pH-impedance test. The study aims to enroll 369 infants, but its current status is unclear.
- Study design
- This is a single-center, randomized controlled trial with three groups (natural maturation, omeprazole, or AR formula) and plans to enroll 369 participants.
- What's involved
- If eligible, your infant will be randomly assigned to one of three treatment groups for 4 weeks. A second pH-impedance test will be done at 4 weeks or before discharge.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcomes will be measured at 4 weeks of therapy or at discharge, whichever comes first.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
GERD Infant Feeding Therapeutics Trial (GIFT Trial)
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Sudarshan R [email protected] · PRINCIPAL_INVESTIGATOR · Nationwide Children's Hospital
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Achievement of primary outcome: Improvement or maintenance of oral feeding and/or absence of GERD symptoms (based on feeding method at inception)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 treatmentAt 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 treatmentAt 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 treatmentAt 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 treatmentAt 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.