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Cerebral Physiology of NOWS (NIRS for NOWS)

18 agosto 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

46

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Anna Thomas, MD
  • Numero di telefono: 3179081096
  • Email: aeschwar@iu.edu

Backup dei contatti dello studio

  • Nome: Hannah Rykovich, RN
  • Numero di telefono: 3174740725
  • Email: hsrakow@iu.edu

Luoghi di studio

  • Stati Uniti
    • Indiana
      • Indianapolis, Indiana, Stati Uniti, 46202
        • Reclutamento
        • Indiana University - Riley Hospital for Children
        • Investigatore principale:
          • Anna Thomas, MD
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino

Accetta volontari sani

Sì

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Diagnostico
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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).
Dispositivo: 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).
Sperimentale: 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).
Dispositivo: 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).
Sperimentale: 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).
Dispositivo: 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).

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Daily measurements of cerebral oxygenation
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Severity of neonatal opioid withdrawal
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Indiana University

Collaboratori

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

Investigatori

  • Investigatore principale: Anna Thomas, MD, Indiana University
  • Investigatore principale: Silvina Ferradal, PhD, Indiana University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

11 agosto 2026

Completamento primario (Stimato)

1 agosto 2027

Completamento dello studio (Stimato)

1 agosto 2027

Date di iscrizione allo studio

Primo inviato

11 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

26 maggio 2026

Primo Inserito (Effettivo)

28 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

19 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

18 agosto 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 28208
  • 1R21DA063767-01 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

Sì

prodotto fabbricato ed esportato dagli Stati Uniti

Sì

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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