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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21DA063767-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Indiana Clinical and Translational Sciences Institute | OTHER |
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prenatal opioid exposure (POE) | Experimental | A total of 20 newborns with prenatal opioid exposure will have daily bedside FD-NIRS/DCS measurements of cerebral oxygen saturation (SOâ‚‚), cerebral blood flow (CBF), and cerebral metabolic rate of oxygen consumption (CMROâ‚‚). |
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| Healthy control | Experimental | A total of 20 healthy age-matched newborns will have daily bedside FD-NIRS/DCS measurements of cerebral oxygen saturation (SOâ‚‚), cerebral blood flow (CBF), and cerebral metabolic rate of oxygen consumption (CMROâ‚‚). |
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| Pharmacologic Treatment | Experimental | 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 (SOâ‚‚), cerebral blood flow (CBF), and cerebral metabolic rate of oxygen consumption (CMROâ‚‚). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FD-NIRS and DCS | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Daily measurements of cerebral oxygenation | 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 | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of neonatal opioid withdrawal | 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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Inclusion Criteria:
Infants with prenatal opioid exposure:
Control infants:
Mothers of infants with prenatal opioid exposure:
Mothers of control infants:
Exclusion Criteria:
Infants with prenatal opioid exposure:
Control infants:
Mothers of infants with prenatal opioid exposure:
Mothers of control infants:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anna Thomas, MD | Contact | 3179081096 | aeschwar@iu.edu | |
| Hannah Rykovich, RN | Contact | 3174740725 | hsrakow@iu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Anna Thomas, MD | Indiana University | Principal Investigator |
| Silvina Ferradal, PhD | Indiana University | Principal Investigator |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| From birth to study completion, an average of 14 days. |
| Length of hospital stay | Length of hospital stay in days. | Birth to hospital discharge, an average of 14 days. |
| Need for postnatal pharmacologic treatment | 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 | 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. |