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Maternal voice may dampen pain signals in preterm Babies' brains

NCT ID NCT05404594

Knowledge-focused Sponsor: University Hospital, Strasbourg, France Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 25, 2026 · Last updated Aug 26, 2026 · Updated 1 time

Summary

This study investigates whether a mother's voice can reduce pain in very preterm infants during a routine blood draw. Researchers will measure brain activity in response to the procedure, comparing when the mother talks or sings to when she is absent. The goal is to better understand how pain pathways develop in preterm babies and whether simple, non-drug comfort measures can help.

What this could mean

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

Active substance
Maternal vocal contact (talking or singing) during venipuncture
What this could lead to
If effective, this could lead to simple, non-drug ways to reduce pain in preterm infants during medical procedures, potentially improving their brain development and well-being.
What could go wrong
This is an early-stage study with a small number of participants, so results may not be conclusive. The effect of maternal voice may vary among infants, and the study focuses on measuring brain responses rather than long-term outcomes.

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 80 people

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

Started

Jul 2019

Expected to finish

Dec 2026

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * Experimental group: VPIs of gestational age less than or equal to 33 weeks on the day of birth and hospitalized in the neonatal intermediate care unit or the neonatal intensive care unit of the Neonatal department of the Hautepierre Hospital (Strasbourg University Hospital) * Control group: Healthy full-term babies (\> 37 weeks gestational age) hospitalized in the maternity ward of Strasbourg University Hospital * Consent obtained from both parents * Subject affiliated to a social health insurance plan. Exclusion Criteria: * \- Any malformation known before inclusion * Cerebral lesions discovered on cerebral ultrasound performed as part of the standard management of newborns (Intra-Ventricular Hemorrhages of grade III or IV of the Papile classification, Periventricular Leucomalacia) * Unstable clinical status according to the investigator's judgment * Expected transfer of the child to another hospital before the term of 40 weeks PMAs.

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Conditions

The condition(s) this trial relates to.

Coitus Pain, Procedural Premature Birth

As listed by the trial registrant

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

Pre-term Procedural pain Venipuncture

Contacts and locations

Locations

  • Service de Pédiatrie - Hôpital d'Hautepierre

    Strasbourg, 67000, France

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