Plain-English translation of NCT07610746 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
This study doesn't follow the usual testing phases — it may be an observational study or a different type of research.
Researchers are testing a new optical brain-monitoring device that can measure oxygen levels, blood flow, and oxygen use in a newborn's brain without any needles or invasive procedures. The study aims to see if this device can detect early warning signs of neonatal opioid withdrawal syndrome — a serious condition that affects babies born to mothers who used opioids during pregnancy — so doctors can identify and treat affected infants sooner.
Babies born to mothers on opioid medications or using opioids during pregnancy can develop withdrawal symptoms after birth, which can be serious if not caught early. Right now, doctors don't have a quick, easy way to predict which babies will develop severe withdrawal. This new monitoring device could help identify at-risk babies in their first days of life, before symptoms become severe, allowing doctors to start treatment earlier.
You likely qualify if…
You likely don't qualify if…
If you and your baby qualify, you'll visit the hospital daily for several days after birth. During each visit, researchers will place a small optical sensor on your baby's head — similar to a pulse oximeter — to measure brain oxygen levels, blood flow, and oxygen use. The sensor is painless and takes only a few minutes. If your baby develops severe withdrawal and receives medication treatment, these measurements will continue so doctors can monitor how the brain responds to treatment.
AI-generated summary from trial data · Sep 24, 2026 · Not medical advice
United States
Sponsor
Indiana University
Collaborators
Indiana Clinical and Translational Sciences Institute, National Institute on Drug Abuse (NIDA)
Enrollment target
~46 participants
Started
August 2026
Primary completion
August 2027
Last updated on clinicaltrials.gov in August 2026.
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Central contact
Anna Thomas, MD
Indiana University
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