Improving drug dosing for critically ill infants with heart disease

Real-world Data Enables Pharmacokinetic/Pharmacodynamic-based Drug Dosing in Critically Ill Children

['FUNDING_OTHER'] · DUKE UNIVERSITY · NIH-11032773

This study is looking to find the best way to give heart medicine to critically ill babies, especially those with heart problems, so that it works better and is safer for them.

Quick facts

Phase['FUNDING_OTHER']
Study typeNih_funding
SexAll
SponsorDUKE UNIVERSITY (nih funded)
Locations1 site (DURHAM, UNITED STATES)
Trial IDNIH-11032773 on ClinicalTrials.gov

What this research studies

This research focuses on optimizing drug dosing for critically ill infants, particularly those with heart disease, who often experience low cardiac output. The study aims to enhance the effectiveness of inotropes like milrinone by developing a more accurate dosing strategy that considers the changing physiological conditions of these patients. By using real-world data and advanced pharmacokinetic/pharmacodynamic modeling, the research seeks to identify the best dosing regimens that can adapt to the individual needs of each child. This approach aims to reduce therapeutic failures and toxicities associated with current dosing practices.

Who could benefit from this research

Good fit: Ideal candidates for this research are critically ill infants under 11 years old, particularly those diagnosed with heart disease.

Not a fit: Patients who are not critically ill or do not have heart disease may not benefit from this research.

Why it matters

Potential benefit: If successful, this research could lead to safer and more effective drug dosing for critically ill infants, improving their health outcomes.

How similar studies have performed: Previous research has shown promise in using real-world data and advanced modeling techniques to improve drug dosing in pediatric populations, indicating that this approach could be effective.

Where this research is happening

DURHAM, UNITED STATES

Researchers

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 below.

View on NIH RePORTER →

Conditions: Cardiac Diseases, Cardiac Disorders

Last reviewed 2026-05-15 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.