Brain blood flow and oxygen use in newborns with prenatal opioid exposure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study uses a novel FD-NIRS/DCS device to measure regional brain oxygenation, blood flow, and metabolism in neonates with prenatal opioid exposure and matched controls. It aims to describe early brain physiology trajectories in the first days of life and relate these measurements to short-term clinical outcomes. The approach is non-invasive and builds on prior validation of the technology in infant populations. The study will enroll term or near-term infants with birth weights over 2 kg and will compare those with prenatal opioid exposure to unexposed controls, with data collected in the Riley Hospital for Children system in Indiana.

Why it matters

Who can join: the full rules

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

Where it's running

• Indiana University - Riley Hospital for Children
  Indianapolis, Indiana, United States Recruiting

Study contacts

• Principal investigator: Anna Thomas, MD — Indiana University
• Study coordinator: Anna Thomas, MD
• Email: aeschwar@iu.edu
• Phone: 3179081096

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.