Cerebral Physiology of NOWS (NCT07610746) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Cerebral Physiology of NOWS
46 participantsStarted 2026-06
Plain-language summary
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.
Who can participate
Age range
1 Day
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Daily measurements of cerebral oxygenation
Timeframe: 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
2
Daily measurements of cerebral blood flow
Timeframe: 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
3
Daily measurements of cerebral oxygen consumption
Timeframe: 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