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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ at time 2 study (4 weeks or prior to discharge, whichever is earliest)

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.