Cerebral Physiology of NOWS (NIRS for NOWS)
Early Detection of Neonatal Opioid Withdrawal Syndrome Using a Novel Cerebral Monitor.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Anna Thomas, MD
- 電話番号：3179081096
- メール：aeschwar@iu.edu
研究連絡先のバックアップ
- 名前：Hannah Rykovich, RN
- 電話番号：3174740725
- メール：hsrakow@iu.edu
研究場所
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Indiana
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Indianapolis、Indiana、アメリカ、46202
- 募集
- Indiana University - Riley Hospital for Children
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主任研究者：
- Anna Thomas, MD
-
コンタクト：
- Anna Thomas
- 電話番号：317-908-1096
- メール：aeschwar@iu.edu
-
-
参加基準
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：診断
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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|
実験的：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).
|
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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実験的：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).
|
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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Daily measurements of cerebral oxygenation
時間枠：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
時間枠：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
|
|
Daily measurements of cerebral oxygen consumption
時間枠：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
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Severity of neonatal opioid withdrawal
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
スポンサー
捜査官
- 主任研究者：Anna Thomas, MD、Indiana University
- 主任研究者：Silvina Ferradal, PhD、Indiana University
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 28208
- 1R21DA063767-01 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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