Cerebral Physiology of NOWS (NIRS for NOWS)
Early Detection of Neonatal Opioid Withdrawal Syndrome Using a Novel Cerebral Monitor.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Anna Thomas, MD
- Numer telefonu: 3179081096
- E-mail: aeschwar@iu.edu
Kopia zapasowa kontaktu do badania
- Nazwa: Hannah Rykovich, RN
- Numer telefonu: 3174740725
- E-mail: hsrakow@iu.edu
Lokalizacje studiów
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Indiana
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Indianapolis, Indiana, Stany Zjednoczone, 46202
- Rekrutacyjny
- Indiana University - Riley Hospital for Children
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Główny śledczy:
- Anna Thomas, MD
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Kontakt:
- Anna Thomas
- Numer telefonu: 317-908-1096
- E-mail: aeschwar@iu.edu
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-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
Akceptuje zdrowych ochotników
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Diagnostyczny
- Przydział: Nielosowe
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: 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).
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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).
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Eksperymentalny: 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).
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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).
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Eksperymentalny: 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).
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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).
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Daily measurements of cerebral oxygenation
Ramy czasowe: 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
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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
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Daily measurements of cerebral blood flow
Ramy czasowe: 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
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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
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Daily measurements of cerebral oxygen consumption
Ramy czasowe: 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
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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
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Severity of neonatal opioid withdrawal
Ramy czasowe: From birth to study completion, an average of 14 days.
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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.
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From birth to study completion, an average of 14 days.
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Length of hospital stay
Ramy czasowe: Birth to hospital discharge, an average of 14 days.
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Length of hospital stay in days.
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Birth to hospital discharge, an average of 14 days.
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Need for postnatal pharmacologic treatment
Ramy czasowe: From birth to 7 days of age.
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Whether the infant requires pharmacologic treatment with an opioid to treat severe neonatal opioid withdrawal.
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From birth to 7 days of age.
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Total postnatal opioid exposure
Ramy czasowe: Treatment initiation to completion, an average of 14 days.
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Total cumulative amount of morphine needed to treat neonatal opioid withdrawal in mg/kg (based on birth weight)
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Treatment initiation to completion, an average of 14 days.
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Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Anna Thomas, MD, Indiana University
- Główny śledczy: Silvina Ferradal, PhD, Indiana University
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 28208
- 1R21DA063767-01 (Grant/umowa NIH USA)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
produkt wyprodukowany i wyeksportowany z USA
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