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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

Sponsor: Indiana University · Participants: 46 · Started: Aug 11, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07610746

Locations in the U.S.

IndianaIndiana 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.