Neonatal Opioid WithdrawalNIRS for NOWSNCT07610746
Cerebral Physiology of NOWS
A study testing FD-NIRS and DCS in people with Neonatal Opioid Withdrawal and Neonatal Opioid Withdrawal Syndrome, run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 1 dayHealthy volunteers can take part
- Conditions the study is for
- Neonatal Opioid Withdrawal, Neonatal Opioid Withdrawal Syndrome, Opioid Use Disorder
- What is being tested?
- FD-NIRS and DCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2026to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 1 day
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Indiana University - Riley Hospital for Children
Indianapolis, Indiana, 46202
Anna Thomas, 317-908-1096, aeschwar@iu.edu
Anna Thomas, MD
About this study
Official title: Early Detection of Neonatal Opioid Withdrawal Syndrome Using a Novel Cerebral Monitor.
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.
Read the detailed 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 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.
- Conditions
- Neonatal Opioid Withdrawal, Neonatal Opioid Withdrawal Syndrome, Opioid Use Disorder, Intrauterine Exposure
- Being tested
- FD-NIRS and DCS
- Keywords
- neonatal opioid withdrawal syndrome, near infrared spectroscopy, diffuse correlation spectroscopy
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FD-NIRS and DCSDevice
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 group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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). Receives: Device: FD-NIRS and DCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: From birth to study completion, an average of 14 days.
Length of hospital stay
Length of hospital stay in days.
Measured: Birth to hospital discharge, an average of 14 days.
Need for postnatal pharmacologic treatment
Whether the infant requires pharmacologic treatment with an opioid to treat severe neonatal opioid withdrawal.
Measured: From birth to 7 days of age.
Total postnatal opioid exposure
Total cumulative amount of morphine needed to treat neonatal opioid withdrawal in mg/kg (based on birth weight)
Measured: Treatment initiation to completion, an average of 14 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start11 Aug 2026
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal Opioid WithdrawalStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Indiana Clinical and Translational Sciences Institute, National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Anna Thomas, Indiana University
- Investigators
- Anna Thomas, MD, Principal investigator, Indiana UniversitySilvina Ferradal, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07610746
- Sponsor's protocol ID
- 28208
- Other IDs
- 1R21DA063767-01
- Acronym
- NIRS for NOWS
- Status last verified
- Aug 2026
- First submitted
- 11 May 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Neonatal Opioid Withdrawal Syndrome Using a Novel Cerebral Monitor.
- ClinicalTrials.gov ID
- NCT07610746
- Acronym / sponsor ID
- NIRS for NOWS / 28208
- Conditions
- Neonatal Opioid Withdrawal, Neonatal Opioid Withdrawal Syndrome, Opioid Use Disorder, Intrauterine Exposure
- Keywords
- neonatal opioid withdrawal syndrome, near infrared spectroscopy, diffuse correlation spectroscopy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Indiana Clinical and Translational Sciences Institute, National Institute on Drug Abuse (NIDA)
- Study start
- 11 Aug 2026 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 28 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Prenatal opioid exposure (POE) | Experimental | Device: FD-NIRS and DCSA 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). |
| Healthy control | Experimental | Device: FD-NIRS and DCSA 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). |
| Pharmacologic Treatment | Experimental | Device: FD-NIRS and DCSA 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). |
Who may qualify
- Ages
- Up to 1 day
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- Term born or near-term born (> 36w) infants
- Birth weight > 2 Kg
- History of prenatal opioid exposure
- Term born or near-term born (> 36w) infants
- Birth weight > 2 Kg
Key exclusion criteria (14 listed)
- APGAR score at 5 min < 7
- Any major congenital malformations or genetic syndromes
- Need for positive pressure ventilation in the delivery room
- APGAR score at 5 min < 7
- Any major congenital malformations or genetic syndromes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FD-NIRS and DCSThe 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). | Device | Healthy control, Pharmacologic Treatment, Prenatal opioid exposure (POE) |
Primary outcome
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.
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.
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.
4 secondary outcomes
Severity of neonatal opioid withdrawal
Time frame: From birth to study completion, an average of 14 days.
Length of hospital stay
Time frame: Birth to hospital discharge, an average of 14 days.
Need for postnatal pharmacologic treatment
Time frame: From birth to 7 days of age.
Total postnatal opioid exposure
Time frame: Treatment initiation to completion, an average of 14 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anna Thomas, MD principal investigator
Indiana University
Silvina Ferradal, PhD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FD-NIRS and DCS in people with Neonatal Opioid Withdrawal and Neonatal Opioid Withdrawal Syndrome, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Thomas, MD (3179081096, aeschwar@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.