Pathophysiology-based GERD management in NICU infants guided by pH-impedance testing
Official title: Pathophysiological Evidence Driven Management of GERD in Neonatal ICU Infants: Randomized Controlled Trial
Funded at Research Inst Nationwide Children's Hosp · NIH-11399922 · Data updated 2026-11-12
A NICU randomized trial tests how newborns with suspected GERD respond to standard care, acid-suppressing therapy, or thicker feeds guided by objective pH-impedance tests.
Quick facts
| Grant type | R01 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Research Inst Nationwide Children's Hosp NIH-funded |
| Lab location | 1 site (Columbus, United States) |
| Project start | September 15, 2023 |
| Project end | August 31, 2028 |
| Funding year | 2026 |
| Award (this year) | $632,434 |
| NIH project number | 5R01DK136762-04 |
| Project ID | NIH-11399922 on NIH RePORTER |
Who could benefit from this research
✓Could help
Ideal participants are high-risk NICU infants under six months corrected age with suspected GERD who can undergo 24-hour pH-impedance testing.
✕Less likely to help
Very preterm infants or those unable to undergo pH-impedance testing may not benefit from the study.
What this research studies
In this trial, researchers will enroll high-risk infants under six months corrected age and use 24-hour pH- Impedance testing to define GERD. They will compare three approaches—natural maturation, proton pump inhibitors, and thickened feeds with added rice formula—to see how each affects symptoms and hospital course. The study aims to refine diagnostic criteria and develop simple, evidence-based treatment algorithms that could be scaled to other NICUs. The approach combines precise physiological testing with randomized therapy assignment to understand which strategy works best for this vulnerable population.
Why it matters
Potential benefit: If successful, the trial could lead to clearer, safer treatment paths for NICU infants with suspected GERD, potentially reducing unnecessary medications and hospital stays.
How similar studies have gone: Prior trials have not used objective pH-impedance criteria to compare therapies in NICU GERD, making this approach relatively novel but building on physiological testing foundations.
Where this research is happening
-
Research Inst Nationwide Children's Hosp
Columbus, United States Active
Researchers
- Principal investigator: Jadcherla, Sudarshan R — Research Inst Nationwide Children's Hosp
- Study coordinator: Jadcherla, Sudarshan R
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About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.