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AR Formula vs Omeprazole for Infant Acid Reflux (GIFT Trial)

N/A
Recruiting
Led By Sudarshan R sudarshan.jadcherla@nationwidechildrens.org
Research Sponsored by Nationwide Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No current GERD therapies
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)
Must not have
Upper gastrointestinal malformations requiring surgery
Positive airway pressure or oxygen flow > 4 LPM
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at time 2 study (4 weeks or prior to discharge, whichever is earliest)
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to study the effects of three different treatments on infants diagnosed with GERD in the NICU. The treatments being compared are natural maturation, proton pump inhibitors (PPIs), and

Who is the study for?
This trial is for NICU infants with a confirmed GERD diagnosis, who are on full enteral feeds and not currently receiving any GERD treatment. Infants must meet specific pH-impedance criteria to qualify.
What is being tested?
The GIFT Trial compares three treatments for infant GERD over four weeks: natural growth without intervention, Omeprazole (a proton pump inhibitor), and AR formula feeding. The main focus is on successful oral feeding and the absence of troublesome symptoms.
What are the potential side effects?
Potential side effects may include digestive issues related to each therapy. Omeprazole might cause stomach pain, gas, nausea, vomiting, or diarrhea. AR formula could lead to altered bowel movements or discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am not currently on any treatments for acid reflux.
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My baby is in the NICU, diagnosed with GERD based on specific tests.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I need surgery for a stomach or upper intestine problem.
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I use a breathing aid with more than 4 liters per minute of air or oxygen.
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I do not have any known lethal genetic disorders.
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I need medication or surgery for a serious brain or nerve problem.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at time 2 study (4 weeks or prior to discharge, whichever is earliest)
This trial's timeline: 3 weeks for screening, Varies for treatment, and at time 2 study (4 weeks or prior to discharge, whichever is earliest) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Achievement of : Improvement or maintenance of oral feeding and/or absence of GERD symptoms (based on feeding method at inception)
Decrease in ARI on treatment
Decrease in symptom associated probability on treatment
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Active Control
Group I: Proton Pump Inhibitor (PPI)Active Control1 Intervention
Omeprazole will be prescribed for 4 weeks using the dose of 1.5mg/kg/dose daily.
Group II: Natural maturationActive Control1 Intervention
Allows for time for infant maturation without treatment.
Group III: Added Rice (AR) FormulaActive Control1 Intervention
Added rice formula will be ordered as the infant diet for the 4-week treatment period.

Find a Location

Who is running the clinical trial?

Nationwide Children's HospitalLead Sponsor
348 Previous Clinical Trials
5,227,413 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,432 Previous Clinical Trials
4,322,872 Total Patients Enrolled
Sudarshan R sudarshan.jadcherla@nationwidechildrens.orgPrincipal InvestigatorNationwide Children's Hospital
~246 spots leftby Nov 2027
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