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Cerebral Physiology of NOWS

Indiana University · with Indiana Clinical and Translational Sciences Institute, National Institute on Drug Abuse (NIDA) · NCT07610746

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Up to age 0 mo · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
46
US sites recruiting
1
Study start
August 11, 2026
Record last updated
August 19, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: FD-NIRS and DCS

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

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • Indiana University - Riley Hospital for Children

    Indianapolis, IN 46202

    Site contact: Anna Thomas · 317-908-1096 · aeschwar@iu.edu

Study contacts (from the official record)

  • Anna Thomas, MD · 3179081096 · aeschwar@iu.edu
  • Hannah Rykovich, RN · 3174740725 · hsrakow@iu.edu
All healthy volunteers studies in Indiana →
Cerebral Physiology of NOWS (NCT07610746) | Bored Studies