Massage and singing: which helps preemies develop better?
NCT ID NCT07261046
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares two early interventions for premature infants: ATVV (a combination of massage, talking, eye contact, and gentle rocking) versus parents singing softly. Researchers will enroll 90 babies born between 30-34 weeks and track their motor and cognitive skills at 6 months. The goal is to see which approach better supports healthy development.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ATVV (Auditory, Tactile, Visual and Vestibular stimulation) and parental singing
- What this could lead to
- If ATVV works better than singing, it could offer a simple, drug-free way to improve motor and cognitive development in premature babies.
- What could go wrong
- This is a small, early-stage study with only 90 infants, so results may not apply to all preemies. The benefits might be small or not last long-term.
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
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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
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About 90 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2025
An estimate. Start dates often move.
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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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
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0 to 4 weeks
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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: 1. For premature infants: birth between 30 and 34 weeks of gestation plus 6 days, and weighing more than 1800 g at the start of the trial. 2. For full-term infants: pregnancy and birth without complications at or after 37 weeks of gestation, with an Apgar score ≥7 at 10 minutes after birth. 3. For parents or legal guardians: * Parents over the age of 18 * Parent agreeing to be filmed with their infant (parent who will be responsible for the treatment) * Parents capable of understanding the information document * Parent affiliated with or beneficiary of the French social security system * Parents who have been informed and have freely given their informed written consent no later than the day of inclusion. Exclusion Criteria: 1. For premature infants: * Birth before 30 weeks of gestation * Weight less than 1800 g at the start of the trial * Morbidities related to prematurity (necrotizing enterocolitis, cerebral parenchymal damage, stage III and IV intraventricular hemorrhages) * Presence of a congenital malformation or chromosomal abnormality * Known sensory, motor, or central nervous system impairment * Patient receiving non-invasive ventilation at 34 weeks gestational age (CPAP and high-flow nasal cannula) 2. For full-term infants: * Birth before 37 weeks gestation * Birth with complications 3. For the parent providing the treatment and the infant: * Presence of a known sensory, motor, or central nervous system impairment * Presence of a congenital condition * Presence of psychological distress in the parent 4. For both parents: * Under guardianship, conservatorship, or legal protection * Situation of extreme psychosocial instability and/or mention of domestic and/or intra-family violence * Illicit drug or alcohol use by the mother during the perinatal period * Participant is in another study with an ongoing exclusion period during inclusion * Involuntary hospitalization
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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Clinique Bouchard
Marseille, France
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Hopital Saint-Joseph
Marseille, France
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