Cerebral Physiology of NOWS

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Indiana University
Study ID
NCT07610746
Status
Recruiting
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Conditions

  • Intrauterine Exposure
  • Neonatal Opioid Withdrawal
  • Neonatal Opioid Withdrawal Syndrome
  • Opioid Use Disorder

Eligibility Criteria

Sex
ALL
Age
N/A - 1 Day
Healthy Volunteers
Accepted

Interventions

  • FD-NIRS and DCS — DEVICE
    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).

Study Details

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.

Key Dates

First listed
May 28, 2026
Start date
Aug 11, 2026
Status verified
Aug 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
46 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Prenatal opioid exposure (POE)
    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).
  • Experimental: Healthy control
    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).
  • Experimental: Pharmacologic Treatment
    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).

Primary Outcome Measure

Daily measurements of cerebral oxygenation [ Time Frame: From birth up to 5 days of life for the control and POE infants; from birth to study completion, an average of 14 days, for pharmacologically-treated infants ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Indiana University - Riley Hospital for ChildrenIndianapolisIndiana46202
Anna Thomas
[email protected]
317-908-1096
Anna Thomas, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Indiana University - Riley Hospital for Children· Indianapolis, IN

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