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New device could spot opioid withdrawal in newborns faster

NCT ID NCT07610746

Diagnosis Sponsor: Indiana University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 20, 2026 · Updated 2 times

Summary

This study will test a new, non-invasive device that measures blood flow and oxygen levels in the brains of newborn babies. Researchers will compare babies who were exposed to opioids before birth with those who were not. The goal is to see if the device can detect signs of opioid withdrawal earlier than current methods, helping doctors provide faster care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 46 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2026

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 1 day

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

neonatal abstinence syndrome opiate dependence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Intrauterine exposure Neonatal opioid withdrawal Neonatal opioid withdrawal syndrome Opioid use disorder

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Indiana University - Riley Hospital for Children

    RECRUITING

    Indianapolis, Indiana, 46202, United States

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Other studies related to the condition(s) this trial covers.