NIH-funded research R01 grant

Optimizing caffeine therapy to protect kidneys and brain in preterm babies

Official title: Optimizing Caffeine Therapy for Hypoxia in Preterm Neonates: A Randomized Trial Assessing Efficacy, Acute Kidney and Brain Injury, Safety, and Pharmacokinetics

Funded at University of Wisconsin-Madison · NIH-11400275 · Data updated 2026-11-12

A randomized study tests whether giving caffeine to very premature babies with kidney and brain hypoxia can reduce kidney injury and improve early brain and kidney outcomes.

Quick facts

Grant typeR01 grant
Study typeNIH-funded research
Funding institutionUniversity of Wisconsin-Madison
NIH-funded
Lab location1 site (Madison, United States)
Project startSeptember 1, 2025
Project endMay 31, 2030
Funding year2026
Award (this year)$327,289
NIH project number5R01HD116793-02
Project IDNIH-11400275 on NIH RePORTER

Who could benefit from this research

Could help

Preterm neonates at risk for acute kidney injury who are receiving caffeine as part of standard neonatal care.

Less likely to help

Some infants may not experience kidney hypoxia or may not respond to caffeine treatment.

What this research studies

This project uses caffeine, already common in neonatal care, in a carefully designed trial to see if it can prevent kidney injury in preterm infants by improving oxygen delivery to the kidneys and brain. Researchers will monitor kidney and brain oxygenation with noninvasive sensors and track safety, pharmacokinetics, and short-term outcomes. If successful, the study could pave the way for a multicenter trial and changes in how caffeine is used to protect fragile newborns.

Why it matters

Potential benefit: If effective, this approach could reduce kidney injury in preterm infants and improve longer-term kidney and brain health.

How similar studies have gone: Prior studies suggest caffeine may lower AKI risk, but rigorous randomized trials focused on AKI prevention in this population are needed.

Where this research is happening

  • University of Wisconsin-Madison
    Madison, United States
    Active

Researchers

  • Principal investigator: Harer, Matthew — University of Wisconsin-Madison
  • Study coordinator: Harer, Matthew

Related research

Other NIH-funded projects on the same topics.

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.