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Cerebral Physiology of NOWS

RecruitingNA

Sponsor: Indiana University

Conditions: Neonatal Opioid Withdrawal, Neonatal Opioid Withdrawal Syndrome, Opioid Use Disorder, Intrauterine Exposure

Interventions: FD-NIRS and DCS

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: — to 1 Day

Healthy volunteers: Yes

Study type: INTERVENTIONAL

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

Locations (1)

Indianapolis, Indiana, United States