Best oxygen targets for newborns with birth-related lung and brain injury

Optimal Oxygenation in Neonatal Lung Injury

['FUNDING_R01'] · UNIVERSITY OF CALIFORNIA AT DAVIS · NIH-11319814

This project compares two oxygen level targets during cooling and adds IV sildenafil to see if newborns with lung problems and brain injury recover better.

Quick facts

Phase['FUNDING_R01']
Study typeNih_funding
SexAll
SponsorUNIVERSITY OF CALIFORNIA AT DAVIS (nih funded)
Locations1 site (DAVIS, UNITED STATES)
Trial IDNIH-11319814 on ClinicalTrials.gov

What this research studies

If your baby has birth-related brain injury and trouble breathing, doctors will use whole-body cooling and compare two target oxygen ranges for the first 72 hours. They will monitor breathing, blood oxygen, and blood flow to the brain while measuring markers of oxidative stress. The team will also look at how inhaled nitric oxide and IV sildenafil affect the lungs and brain under the different oxygen targets. Drug levels and how cooling changes sildenafil behavior will be measured to guide dosing.

Who could benefit from this research

Good fit: Newborns receiving whole-body hypothermia for moderate to severe hypoxic-ischemic encephalopathy who also have meconium aspiration syndrome or persistent pulmonary hypertension are the ideal candidates.

Not a fit: Babies without HIE or significant neonatal lung disease, older children, and adults would not be eligible and would not benefit from this neonatal-focused work.

Why it matters

Potential benefit: If successful, this approach could reduce brain injury, improve lung blood flow, and lower the need for extracorporeal support in affected newborns.

How similar studies have performed: Therapeutic cooling and inhaled nitric oxide are established treatments and sildenafil is used for neonatal pulmonary hypertension, but combining specific higher oxygen targets with IV sildenafil during cooling is relatively new and not well studied.

Where this research is happening

DAVIS, 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.