Using objective testing to guide reflux care for newborns in the NICU
Official title: Pathophysiological Evidence Driven Management of GERD in Neonatal ICU Infants: Randomized Controlled Trial
Funded at Research Inst Nationwide Children's Hosp · NIH-11167841 · Data updated 2026-11-12
This project compares three approaches—natural maturation, acid-suppressing medicine (PPI), and thickened feeds with added rice—to help NICU infants under six months who have reflux confirmed by 24-hour pH-impedance testing.
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 | 2025 |
| Award (this year) | $637,667 |
| NIH project number | 5R01DK136762-03 |
| Project ID | NIH-11167841 on NIH RePORTER |
Who could benefit from this research
✓Could help
Ideal candidates are high-risk infants under six months corrected age who are hospitalized in the NICU and have reflux documented by 24-hour pH-impedance testing.
✕Less likely to help
Infants without physiologic reflux on pH-impedance testing, older outpatients, or babies with unrelated primary conditions are unlikely to benefit from these specific treatment comparisons.
What this research studies
If your infant is in the NICU and has symptoms of reflux, doctors will use 24-hour pH-impedance testing to determine whether reflux is present and what mechanisms are involved. Babies who meet the physiologic criteria will be randomly assigned to one of three common approaches: expectant management for natural maturation, a proton pump inhibitor (PPI), or thickened feeds using added rice formula. Researchers will follow infants during the hospital stay with active follow-up to track symptoms, physiologic markers, and adverse effects. The aim is to develop simpler, evidence-based treatment plans that reduce unnecessary medicines and shorten hospital stays.
Why it matters
Potential benefit: If successful, this work could help clinicians choose safer, more effective reflux treatments for NICU infants and reduce unnecessary medications and hospital days.
How similar studies have gone: Previous infant GERD trials often lacked objective pH-impedance criteria and produced mixed results, so this randomized approach using physiologic diagnostics is relatively novel.
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.