Using objective testing to guide reflux care for newborns in the NICU
Pathophysiological Evidence Driven Management of GERD in Neonatal ICU Infants: Randomized Controlled Trial
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 ID | NIH-11167841 on NIH RePORTER |
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.
Who could benefit from this research
Good fit: 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.
Not a fit: 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.
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 performed: 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
Columbus, United States
- 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
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 below.