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New score could predict which CMV-Infected newborns will face hearing loss

NCT ID NCT01923636

Knowledge-focused Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study looked at 254 newborns with congenital cytomegalovirus (CMV) infection to find early signs that predict hearing loss or other brain-related problems at age 1. Researchers used clinical exams, brain scans, and lab tests to build a scoring system. The goal is to help doctors identify high-risk babies early and guide follow-up care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to a reliable way to predict which newborns with congenital CMV will develop hearing loss or other problems, helping doctors decide on early treatment.
What could go wrong
This is an observational study, not a treatment trial. The score may not be accurate enough for all babies, and results may not apply to different populations.

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

254 people

The number who actually took part.

Started

Sep 2013

Finished

May 2022

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

1 day to 1 month

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: Main objective: Neonate less than 1 month with congenital CMV infection at birth objectified by the detection of CMV in a urine sample, in saliva or blood (fresh or Guthrie card) obtained in the first 10 days life * Whose parents accept regular monitoring by the paediatrician investigator * For which a medical examination has been made * Affiliated with a social security system * And whose mother has given its written consent to the participation of their child to study Exclusion Criteria: \- Children participating in an interventional study

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Conditions

The condition(s) this trial relates to.

cytomegalovirus infection fetal cytomegalovirus syndrome

As listed by the trial registrant

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

Congenital cytomegalovirus infection

Contacts and locations

Locations

  • Hôpital Necker Enfants Malades

    Paris, 75015, France

More trials for these conditions

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