Cerebral Physiology of NOWS
Starting soon · Not applicable
Conditions studied: Neonatal Opioid Withdrawal, Neonatal Opioid Withdrawal Syndrome, Opioid Use Disorder, Intrauterine Exposure
In brief
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.
Key facts
- Study ID
- NCT07610746
- Run by
- Indiana University
- People needed
- 46
- Starts
- 2026-06-01
- Expected to finish
- 2027-06-01
- Last updated by the study team
- 2026-06-05
Who can join
Age: any, up to 0. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Full record on ClinicalTrials.gov
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