Early Detection of Neonatal Opioid Withdrawal Syndrome Using a Novel Cerebral Monitor.
Indiana University
Summary
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.
Description
The investigators propose to use a novel optical-based device that combines two advanced NIRS techniques, frequency-domain NIRS (FD-NIRS) and diffuse correlation spectroscopy (DCS), to quantify regional cerebral oxygenation (SO2), cerebral blood flow (CBF) and cerebral oxygen consumption (CMRO2) in neonates with similar ease of use as commercial NIRS devices, offering a more comprehensive metabolic profile of early brain function. Our technology has been validated in infant populations, demonstrating robust biomarkers of brain health and function in both healthy and at-risk infants. A pilot st…
Eligibility
- Age range
- Up to 0 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: Infants with prenatal opioid exposure: * Term born or near-term born (\> 36w) infants * Birth weight \> 2 Kg * History of prenatal opioid exposure Control infants: * Term born or near-term born (\> 36w) infants * Birth weight \> 2 Kg Mothers of infants with prenatal opioid exposure: * greater or equal to 19 years of age * Use of opioid substances during pregnancy - Defined as pregnant women who 1) are clinically diagnosed as having an opioid use disorder and are on methadone or buprenorphine maintenance program or 2) have a urine drug test positive for prescribed or i…
Interventions
- DeviceFD-NIRS and DCS
The investigators will use a novel optical-based device that combines two advanced NIRS techniques, frequency-domain NIRS (FD-NIRS) and diffuse correlation spectroscopy (DCS), to quantify regional cerebral oxygenation (SO2), cerebral blood flow (CBF) and cerebral oxygen consumption (CMRO2).
Location
- Indiana University - Riley Hospital for ChildrenIndianapolis, Indiana