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Cerebral Physiology of NOWS
RecruitingHealthy volunteers welcome
Early Detection of Neonatal Opioid Withdrawal Syndrome Using a Novel Cerebral Monitor.
Who can join
1 Day · All sexes · Healthy volunteers welcome
Full eligibility criteria
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
About the study
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.
What is being tested
- FD-NIRS and DCS (device)
Sponsor: Indiana University · Participants: 46 · Started: Aug 11, 2026
Contact the study team
- Anna Thomas, MD · Phone: 3179081096
- Hannah Rykovich, RN · Phone: 3174740725
Official record on ClinicalTrials.gov — NCT07610746
Locations in the U.S.
| Indiana | Indiana University - Riley Hospital for Children, Indianapolis |
Conditions
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.