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Cerebral Physiology of NOWS

NCT07610746 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2026-05-28

No results posted yet for this study

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

Interventions

DEVICE

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).

Sponsors & Collaborators

  • Indiana Clinical and Translational Sciences Institute

    collaborator OTHER

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Indiana University

    lead OTHER

Principal Investigators

  • Anna Thomas, MD · Indiana University

  • Silvina Ferradal, PhD · Indiana University

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
1 Day
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2027-04-30
Completion
2027-06-30
FDA Device
Yes

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07610746 on ClinicalTrials.gov