Cerebral Physiology for Neonatal Opioid Withdrawal Syndrome
(NIRS for NOWS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This study will use a new device to measure blood flow and oxygen levels in the brains of newborn infants who have had exposure to opioid medications in the womb, compared to newborns who have not had any exposure.
Who Is on the Research Team?
Anna Thomas, MD
Principal Investigator
Indiana University
Silvina Ferradal, PhD
Principal Investigator
Indiana University
Are You a Good Fit for This Trial?
This trial is for newborns born at or after 36 weeks, weighing over 2 kg, whose mothers are at least 19 years old and used opioids during pregnancy (either prescribed or illicit).Inclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- FD-NIRS and DCS
Trial Overview
Researchers are using a new device to measure brain blood flow and oxygen levels in babies exposed to opioids before birth, compared to those who were not exposed.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
A total of 20 newborns with prenatal opioid exposure will have daily bedside FD-NIRS/DCS measurements of cerebral oxygen saturation (SO₂), cerebral blood flow (CBF), and cerebral metabolic rate of oxygen consumption (CMRO₂).
A group of 6 newborns with POE who are treated pharmacologically for severe neonatal opioid withdrawal syndrome will have daily bedside FD-NIRS/DCS measurements of cerebral oxygen saturation (SO₂), cerebral blood flow (CBF), and cerebral metabolic rate of oxygen consumption (CMRO₂).
A total of 20 healthy age-matched newborns will have daily bedside FD-NIRS/DCS measurements of cerebral oxygen saturation (SO₂), cerebral blood flow (CBF), and cerebral metabolic rate of oxygen consumption (CMRO₂).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Indiana University
Lead Sponsor
Indiana Clinical and Translational Sciences Institute
Collaborator
National Institute on Drug Abuse (NIDA)
Collaborator
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