Recruiting

Observational Study

Sponsor:

Indiana University

Code:

NCT07610746

Conditions

Neonatal Opioid Withdrawal

Neonatal Opioid Withdrawal Syndrome

Opioid Use Disorder

Intrauterine Exposure

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

Interventions

FD-NIRS and DCS

Study Details

Brief summary:

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.

Conditions

Neonatal Opioid Withdrawal

Neonatal Opioid Withdrawal Syndrome

Opioid Use Disorder

Intrauterine Exposure

Study ID

NCT07610746

Start date

Aug 11, 2026

Status verified date

Aug, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

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

Study Design

Enrollment

46 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Prenatal opioid exposure (POE)

A total of 20 newborns with prenatal opioid exposure will have daily bedside FD-NIRS/DCS measurements of cerebral oxygen saturation (SO₂), cerebral blood flow (CBF), and cerebral metabolic rate of oxygen consumption (CMRO₂).

experimental: Healthy control

A total of 20 healthy age-matched newborns will have daily bedside FD-NIRS/DCS measurements of cerebral oxygen saturation (SO₂), cerebral blood flow (CBF), and cerebral metabolic rate of oxygen consumption (CMRO₂).

experimental: Pharmacologic Treatment

A group of 6 newborns with POE who are treated pharmacologically for severe neonatal opioid withdrawal syndrome will have daily bedside FD-NIRS/DCS measurements of cerebral oxygen saturation (SO₂), cerebral blood flow (CBF), and cerebral metabolic rate of oxygen consumption (CMRO₂).

Interventions

FD-NIRS and DCS

The investigators will use a novel optical-based device that combines two advanced NIRS techniques, frequency-domain NIRS (FD-NIRS) and diffuse correlation spectroscopy (DCS), to quantify regional cerebral oxygenation (SO2), cerebral blood flow (CBF) and cerebral oxygen consumption (CMRO2).

Primary outcome measure

  • Daily measurements of cerebral oxygenation [ Time Frame: From birth up to 5 days of life for the control and POE infants; from birth to study completion, an average of 14 days, for pharmacologically-treated infants ]
  • Daily measurements of cerebral blood flow [ Time Frame: From birth up to 5 days of life for the control and POE infants; from birth to study completion, an average of 14 days, for pharmacologically-treated infants ]
  • Daily measurements of cerebral oxygen consumption [ Time Frame: From birth up to 5 days of life for the control and POE infants; from birth to study completion, an average of 14 days, for pharmacologically-treated infants ]

Central Contacts and Locations

Central contacts

Anna Thomas, MD

3179081096aeschwar@iu.edu

Hannah Rykovich, RN

3174740725hsrakow@iu.edu

Locations

Indiana University - Riley Hospital for Children

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Anna Thomas

317-908-1096aeschwar@iu.edu

Principal Investigator:

Anna Thomas, MD

More Information

Sponsor

Indiana University

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Keywords

  • neonatal opioid withdrawal syndrome
  • near infrared spectroscopy
  • diffuse correlation spectroscopy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Indiana University on 2026-08-19.