NCT07610746 · Indiana University
Cerebral Physiology of NOWS
(NIRS for NOWS)
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
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).
Primary outcome measures
Daily measurements of cerebral oxygenation
Time frame: 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.
Daily measurements of cerebral blood flow
Time frame: 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.
Daily measurements of cerebral oxygen consumption
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Indianapolis, Indiana
Collaborators
Indiana Clinical and Translational Sciences Institute, National Institute on Drug Abuse (NIDA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 19, 2026 · Source of record for eligibility and locations