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NCT Number: NCT07610746

Cerebral Physiology of NOWS

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.

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Key information

Conditions

Neonatal Opioid Withdrawal Chemically-Induced Disorders Intrauterine Exposure Mental Disorders Narcotic-Related Disorders Neonatal Opioid Withdrawal Syndrome Opioid Use Disorder Opioid-Related Disorders Substance-Related Disorders

Age range

Up to 1 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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 study at Riley Hospital for Children has already revealed differences in absolute cerebral oxygenation (SO2) as measured by quantitative FD-NIRS instrumentation in a small sample of neonates with POE and age-matched controls on the first 24 hours of life.

The investigators hypothesize that infants who develop severe NOWS will exhibit early measurable alterations in cerebral oxygenation, blood flow, and/or metabolism in the early postnatal period. Thus, the investigators propose to acquire FD-NIRS/DCS measurements in infants with prenatal opioid exposure (POE) in their first days of life.

Aim 1: Determine early trajectories of cerebral physiology in neonates with POE using a non-invasive FD-NIRS/DCS device.

Aim 2: Investigate early associations between FD-NIRS/DCS measurements and short-term clinical outcomes in neonates with POE.

Aim 3: Monitor changes in cerebral physiology during pharmacologic treatment in infants with severe NOWS.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 illicit opioids

Mothers of control infants:

  • greater than or equal to 19 years of age

Exclusion criteria

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

Treatment and study plan

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).

Primary outcomes

  1. 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

    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.

  2. Daily measurements of cerebral blood flow

    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

    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.

  3. Daily measurements of cerebral oxygen consumption

    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

    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.

Secondary outcomes

  1. Severity of neonatal opioid withdrawal

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

    The numerical modified Finnegan score (FNAST) or the Eat, Sleep, Console (ESC) score, depending on which tool is used for scoring at the site, will be recorded closest in proximity to measurements of cerebral physiology. The FNAST is a long-standing scoring tool that gives a numerical score as a measure of severity of withdrawal, with higher scores being more severe, up to a maximum of 24. The ESC score is a newer scoring tool that is not numerical but rather normal or abnormal in 3 categories of symptoms. Having an abnormal score for any of the 3 categories may qualify for intervention.

  2. Length of hospital stay

    Time frame: Birth to hospital discharge, an average of 14 days.

    Length of hospital stay in days.

  3. Need for postnatal pharmacologic treatment

    Time frame: From birth to 7 days of age.

    Whether the infant requires pharmacologic treatment with an opioid to treat severe neonatal opioid withdrawal.

  4. Total postnatal opioid exposure

    Time frame: Treatment initiation to completion, an average of 14 days.

    Total cumulative amount of morphine needed to treat neonatal opioid withdrawal in mg/kg (based on birth weight)

Study contacts

Contact information is provided by the study sponsor or research team.

Anna Thomas, MD

CONTACT

[email protected]

3179081096

Hannah Rykovich, RN

CONTACT

[email protected]

3174740725

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • Indiana Clinical and Translational Sciences Institute
  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Early Detection of Neonatal Opioid Withdrawal Syndrome Using a Novel Cerebral Monitor.

Acronym: NIRS for NOWS

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 28, 2026
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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