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Cerebral Physiology of NOWS (NIRS for NOWS)

18 augustus 2026 bijgewerkt door: Anna Thomas, Indiana University

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

46

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

  • Naam: Hannah Rykovich, RN
  • Telefoonnummer: 3174740725
  • E-mail: hsrakow@iu.edu

Studie Locaties

  • Verenigde Staten
    • Indiana
      • Indianapolis, Indiana, Verenigde Staten, 46202
        • Werving
        • Indiana University - Riley Hospital for Children
        • Hoofdonderzoeker:
          • Anna Thomas, MD
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind

Accepteert gezonde vrijwilligers

Ja

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Diagnostisch
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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).
Apparaat: FD-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).
Experimenteel: 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).
Apparaat: FD-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).
Experimenteel: 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).
Apparaat: FD-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).

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Daily measurements of cerebral oxygenation
Tijdsspanne: 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.
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
Tijdsspanne: 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.
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
Tijdsspanne: 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.
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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Severity of neonatal opioid withdrawal
Tijdsspanne: 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.
From birth to study completion, an average of 14 days.
Length of hospital stay
Tijdsspanne: Birth to hospital discharge, an average of 14 days.
Length of hospital stay in days.
Birth to hospital discharge, an average of 14 days.
Need for postnatal pharmacologic treatment
Tijdsspanne: From birth to 7 days of age.
Whether the infant requires pharmacologic treatment with an opioid to treat severe neonatal opioid withdrawal.
From birth to 7 days of age.
Total postnatal opioid exposure
Tijdsspanne: 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)
Treatment initiation to completion, an average of 14 days.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Indiana University

Medewerkers

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

Onderzoekers

  • Hoofdonderzoeker: Anna Thomas, MD, Indiana University
  • Hoofdonderzoeker: Silvina Ferradal, PhD, Indiana University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

11 augustus 2026

Primaire voltooiing (Geschat)

1 augustus 2027

Studie voltooiing (Geschat)

1 augustus 2027

Studieregistratiedata

Eerst ingediend

11 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

26 mei 2026

Eerst geplaatst (Werkelijk)

28 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

19 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

18 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 28208
  • 1R21DA063767-01 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Ja

product vervaardigd in en geëxporteerd uit de V.S.

Ja

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