Cerebral Physiology of NOWS

NCT07610746 | Not Yet Recruiting FDA Device

• 2 other identifiers: 282081R21DA063767-01
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

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

Keywords

neonatal opioid withdrawal syndrome; near infrared spectroscopy; diffuse correlation spectroscopy

Outcome Measures

Primary Outcomes (3)

• Daily measurements of cerebral oxygenation

  For aims 1 and 2, daily measurements of cerebral oxygenation (%) will be obtained using the bedside optical device in infants with POE and age-matched controls during the first five days after birth. For aim 3, longitudinal measurements of cerebral oxygenation (%) will be obtained using the bedside optical device in infants with severe NOWS undergoing pharmacological treatment.

  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

• Daily measurements of cerebral blood flow

  For aims 1 and 2, daily measurements of cerebral blood flow (cm\^2/s) will be obtained using the bedside optical device in infants with POE and age-matched controls during the first five days after birth. For aim 3, longitudinal measurements of cerebral blood flow (cm\^2/s) will be obtained using the bedside optical device in infants with severe NOWS undergoing pharmacological treatment.

  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

• Daily measurements of cerebral oxygen consumption

  For aims 1 and 2, daily measurements of cerebral oxygen consumption (mol/dl.cm\^2/s) will be obtained using the bedside optical device in infants with POE and age-matched controls during the first five days after birth. For aim 3, longitudinal measurements of cerebral oxygen consumption (mol/dl.cm\^2/s) will be obtained using the bedside optical device in infants with severe NOWS undergoing pharmacological treatment.

  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

Secondary Outcomes (4)

• Severity of neonatal opioid withdrawal

  From birth to study completion, an average of 14 days.

• Length of hospital stay

  Birth to hospital discharge, an average of 14 days.

• Need for postnatal pharmacologic treatment

  From birth to 7 days of age.

• Total postnatal opioid exposure

  Treatment initiation to completion, an average of 14 days.

Study Arms (3)

Prenatal opioid exposure (POE)

EXPERIMENTAL

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).

Device: FD-NIRS and DCS

Healthy control

EXPERIMENTAL

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).

Device: FD-NIRS and DCS

Pharmacologic Treatment

EXPERIMENTAL

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).

Device: FD-NIRS and DCS

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).

Healthy control; Pharmacologic Treatment; Prenatal opioid exposure (POE)

Eligibility Criteria

• Age: Up to 1 Day
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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 illicit opioids
• Mothers of control infants:
• greater than or equal to 19 years of age

You may not qualify if:

• Infants with prenatal opioid exposure:
• APGAR score at 5 min \< 7
• Any major congenital malformations or genetic syndromes
• Need for positive pressure ventilation in the delivery room
• Control infants:
• APGAR score at 5 min \< 7
• Any major congenital malformations or genetic syndromes
• Need for positive pressure ventilation in the delivery room
• Any history of prenatal opioid exposure
• Mothers of infants with prenatal opioid exposure:
• Major maternal illness during pregnancy or delivery that could impact infant cerebral perfusion as deemed by the study investigators (e.g. uterine rupture or preeclampsia)
• Mothers of control infants:
• Major maternal illness during pregnancy or delivery that could impact infant cerebral perfusion as deemed by the study investigators (e.g. uterine rupture or preeclampsia)
• Tobacco, SSRI or any opioid use during pregnancy

Sponsors & Collaborators

• Indiana University: lead
• Indiana Clinical and Translational Sciences Institute: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Anna Thomas, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

• Silvina Ferradal, PhD

  Indiana University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Thomas, MD

CONTACT

3179081096; aeschwar@iu.edu

Hannah Rykovich, RN

CONTACT

3174740725; hsrakow@iu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 11, 2026
• First Posted: May 28, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share