NICU GERD trial: which therapy helps babies feed better?
NCT ID NCT06114836
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study compares three approaches for treating GERD in NICU infants: letting the condition improve naturally, using the drug omeprazole, or using a special added rice formula. Researchers will track 369 babies to see which treatment leads to better feeding and fewer symptoms like vomiting or coughing. The goal is to find the safest and most effective way to manage GERD in these vulnerable infants.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Omeprazole (a proton pump inhibitor) and added rice formula
- What this could lead to
- If this trial succeeds, it could show which GERD treatment works best for NICU infants, helping doctors choose the safest and most effective option.
- What could go wrong
- This is a single-center study with a relatively small sample size, so results may not apply to all infants. The treatments may not show clear differences, and side effects like digestive issues are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 369 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2024
- Expected to finish
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Nov 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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1 day to 8 months
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Nationwide Children's Hospita
RECRUITINGColumbus, Ohio, 43215, United States