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Mom's voice and cuddles may soothe preemie pain during needle sticks

NCT ID NCT06200662

Symptom relief Sponsor: University Hospital, Strasbourg, France 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a mother's voice, touch, and care can reduce pain in very premature newborns during a common blood draw (venipuncture). 48 babies born before 32 weeks will be studied at one hospital. Researchers will compare pain scores when standard non-drug methods are used alone versus when the mother also provides comfort. The goal is to see if involving mothers can improve pain relief and support better brain development.

What this could mean

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

Active substance
maternal intervention (voice, touch, sugar solution, dummy, wrapping)
What this could lead to
If it works, this could offer a simple, drug-free way to reduce pain during blood draws in very premature babies, involving mothers directly in care.
What could go wrong
This is a small, early study with only 48 babies at one hospital. The effect may be small or not work for all preemies, and results may not apply to other hospitals or procedures.

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 48 people

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

Started

Feb 2024

Expected to finish

Feb 2028

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

32 to 34 weeks

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: * Very premature babies born before the gestational age (GA) of 32 weeks of amenorrhoea (SA) whose corrected age (CA) does not exceed 34 SA at the time of their participation. * NN requiring close biological monitoring by a PV. * Hospitalised in the NN medicine and intensive care unit at Strasbourg hospital. * Consent obtained from both holders of parental authority. * Person covered by a social health insurance scheme. Exclusion Criteria: * Any known malformation affecting one or more organs. * Cerebral lesions discovered o n cerebral ultrasound (intraventricular haemorrhage grade \> 2, periventricular leukomalacia). * Unstable clinical state as judged by the investigator and the medical team. * Transfer to another hospital centre expected before the end of the study period. * Mother: Minor. Deprived of liberty by judicial or administrative decision. Under legal protection. Severe psychological pathology. Drug addiction. Difficulty understanding and/or reading the language. French.

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As listed by the trial registrant

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

Premature newborns

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

  • Les Hôpitaux Universitaires

    RECRUITING

    Strasbourg, Bas-Rhin, 67091, France

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