Cyclohexanone exposure during infant heart surgery and child development

Role of Cyclohexanone Toxicity in Mediating Congenital Cardiac Surgery Outcomes

['FUNDING_R01'] · JOHNS HOPKINS UNIVERSITY · NIH-11083069

This project looks at whether a chemical that can leach from plastic medical devices used in infant heart operations is linked to heart recovery and later brain development in babies and young children.

Quick facts

Phase['FUNDING_R01']
Study typeNih_funding
SexAll
SponsorJOHNS HOPKINS UNIVERSITY (nih funded)
Locations1 site (BALTIMORE, UNITED STATES)
Trial IDNIH-11083069 on ClinicalTrials.gov

What this research studies

If your baby needs congenital heart surgery, researchers will measure cyclohexanone — a chemical that can come from plastic medical devices — in blood samples taken during and after surgery. They will track early heart recovery and follow development up to at least 12 months to see if higher chemical levels link with worse outcomes. The team builds on pilot data and animal findings and will account for other medical factors when comparing exposures and outcomes. The long-term aim is to develop prevention strategies, such as safer materials or different procedures, to protect children’s hearts and brains.

Who could benefit from this research

Good fit: Newborns and infants with congenital heart defects who are scheduled for cardiac surgery involving cardiopulmonary bypass or IV infusions are the ideal candidates.

Not a fit: People who are not undergoing congenital heart surgery, older children or adults, or patients whose care does not use plastic devices that release cyclohexanone are unlikely to benefit directly.

Why it matters

Potential benefit: This work could identify a preventable source of harm during infant heart surgery and lead to safer devices or practices that improve cardiac and neurodevelopmental outcomes.

How similar studies have performed: Animal studies and pilot data in newborns have linked cyclohexanone exposure to cardiovascular effects and worse 12-month neurodevelopment, but larger confirmatory studies are still needed.

Where this research is happening

BALTIMORE, 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: Acquired brain injury

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.