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Cerebral Physiology of NOWS (NIRS for NOWS)

18. august 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

46

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

  • Navn: Hannah Rykovich, RN
  • Telefonnummer: 3174740725
  • E-mail: hsrakow@iu.edu

Studiesteder

  • Forenede Stater
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46202
        • Rekruttering
        • Indiana University - Riley Hospital for Children
        • Ledende efterforsker:
          • Anna Thomas, MD
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn

Tager imod sunde frivillige

Ja

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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).
Enhed: 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).
Eksperimentel: 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).
Enhed: 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).
Eksperimentel: 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).
Enhed: 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).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Daily measurements of cerebral oxygenation
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Severity of neonatal opioid withdrawal
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Indiana University

Samarbejdspartnere

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

Efterforskere

  • Ledende efterforsker: Anna Thomas, MD, Indiana University
  • Ledende efterforsker: Silvina Ferradal, PhD, Indiana University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

11. august 2026

Primær færdiggørelse (Anslået)

1. august 2027

Studieafslutning (Anslået)

1. august 2027

Datoer for studieregistrering

Først indsendt

11. maj 2026

Først indsendt, der opfyldte QC-kriterier

26. maj 2026

Først opslået (Faktiske)

28. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

19. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 28208
  • 1R21DA063767-01 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

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Ja

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