Early Detection of Neonatal Opioid Withdrawal Syndrome Using a Novel Cerebral Monitor

Brain Blood Flow and Oxygenation in Infants Exposed to Opioids

A
Anna Elizabeth Thomas

Primary Investigator

Enrolling By Invitation
37 weeks or above
All
Phase N/A
20 participants needed
1 Location

Brief description of study

This study is being conducted to investigate whether blood flow and/or oxygenation in the brain of babies exposed to opioids during pregnancy can predict the severity of neonatal opioid withdrawal symptoms (NOWS). This study will use a novel, safe, non-invasive brain monitoring device to measure blood flow and oxygen levels in newborns who were exposed to opioids during pregnancy.

THIS STUDY IS ENROLLING BY INVITATION ONLY - Potential participants will be identified through routine review of postpartum/maternity, newborn nursery, and NICU census lists at Riley Hospital Maternity Tower and Eskenazi Health Hospital to determine preliminary eligibility. Eligible mothers of infants with prenatal opioid exposure and mothers of control infants will be approached by trained study personnel, who will explain the study and provide the opportunity to ask questions. Mother's who would like their infant(s) to participate will be consented in person in a private setting or by flexible consenting procedures.

Detailed description of study

To characterize early cerebral physiology in neonates with POE and examine their predictive value for early identification of NOWS. Research procedures will take place in the well newborn nurseries and neonatal intensive care units at Riley Hospital Maternity Tower and Eskenazi Health Hospital. Potential participants will be identified through routine review of unit census lists, and recruitment and informed consent discussions will occur in private patient rooms or other quiet, private areas to protect family privacy. If the mother is not available at the hospital, initial introduction of the study may occur via phone call. To capture the dynamic changes in cerebral physiology during the course of pharmacotherapy, we will take FD-NIRS/DCS measurements at the following time points:
1.    Pre-treatment measurement within 24 hours of initiating treatment to establish a baseline for SO2, CBF, and CMRO2. 
2.    Measurements within 24 hours of stabilization after starting pharmacologic treatment.
3.    Post-treatment measurement within 24-48 hours of completing treatment.                  
We will ensure that the FD-NIRS/DCS measurements do not delay pharmacotherapy or clinical management at any time. Individuals with poor quality data or who drop out of the study will be replaced to achieve six adequate datasets for this aim.Study procedures, including non-invasive bedside optical measurements, will be performed in the infant’s hospital room or in the unit treatment room during routine care.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Prenatal opioid exposureprenatal opioid exposure, Neonatal opioid withdrawal symptoms (NOWS), Riley
  • Age: 37 weeks or above
  • Gender: All

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
o    >19 years of age
o    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
o    >19 years of age

Exclusion Criteria
•    Infants with prenatal opioid exposure
    APGAR score at 5 min     Any major congenital malformations or genetic syndromes
    Need for positive pressure ventilation in the delivery room 
•    Control infants
    APGAR score at 5 min     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
o    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
o    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)
o    Tobacco, SSRI or any opioid use during pregnancy

This study investigates how blood flow and oxygen levels in the brains of babies exposed to opioids during pregnancy might predict the severity of neonatal opioid withdrawal symptoms (NOWS). The purpose of this study is to use a safe, non-invasive brain monitoring device to measure these factors in newborns who were exposed to opioids before birth.

The study procedures involve measuring blood flow and oxygen levels using a special device that does not hurt the baby. These measurements will be taken at different times: before treatment, after starting treatment, and after treatment ends. The measurements are done in the baby’s hospital room during regular care and will not delay any medical treatments.

  • Who can participate: Infants exposed to opioids before birth, born at or near full term, and weighing over 2 kg can participate. Control infants with similar birth conditions but no opioid exposure are eligible, while exclusions include major congenital issues or certain medical interventions at birth.
  • Study details: Participants will undergo non-invasive measurements of brain blood flow and oxygen levels using a special device. These measurements will occur during regular hospital care and will not interfere with medical treatments.
Updated on 18 May 2026. Study ID: PNEO-NIH-NIRS-FOR-NOWS, 28208
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only