Premature InfantSynchroPremaNCT03114644
Reading Stories to Premature Babies Reinforces Mother-baby Synchronies?
A study testing Physiologically evaluate the impact of reading history on the mother-baby synchronies in a context of premature birth requiring hospitalization in neonatal medicine. in people with Premature Infant and Mother-Baby Synchrony, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Observations of the early interactions between the infant and his parents highlighted the existence of rhythmic and reciprocal communications that serve as a basis for the mother-baby relationship and the emotional and cognitive development of the baby. Read more about this study
- Who is it for?
- Ages 25 to 37 weeks
- Conditions the study is for
- Premature Infant, Mother-Baby Synchrony
- What is being tested?
- Physiologically evaluate the impact of reading history on the mother-baby synchronies in a context of premature birth requiring hospitalization in neonatal medicine.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteFrance
- Study dates
- 16 Jan 2017to 29 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 37 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- A premature birth between 27 and 37 SA
- At the time of the transfers, the latter must be hospitalized in intensive care and extubated
Who cannot join
- For the baby:
- an unstable medical condition
- Serious somatic complications
- genetic or neurological diseases
- a twin.
- For the mother:
Show all 10Show fewer
- an impossibility to understand and speak the French language
- a mental or cognitive pathology
- an addiction to alcohol or other psychoactive substances
- persons under guardianship or curatorship or deprived of their liberty by a judicial or administrative decision
Trial locations and contacts
1 site in 1 country.
About this study
Observations of the early interactions between the infant and his parents highlighted the existence of rhythmic and reciprocal communications that serve as a basis for the mother-baby relationship and the emotional and cognitive development of the baby.
Read the detailed description
Observations of the early interactions between the infant and his parents highlighted the existence of rhythmic and reciprocal communications that serve as a basis for the mother-baby relationship and the emotional and cognitive development of the baby. In this study, the investigator proposes to focus on premature births (before 37 years) because prematurity disrupts the synchronization of these mother-baby communication. For several years, reading of stories and nursery rhymes has been used by the liaison child psychiatry team in the neonatal medicine and pediatric intensive care unit of the University Hospital of Amiens, as a therapeutic mediation tool allowing And support for parent-child interactions. Thus, it is desirable to explore the impact of reading stories and rhymes on mother-baby synchronies. The study is innovative because it simultaneously explores several fields: physiological, neuroendocrine, cognitive and psychic. A pilot study carried out in 2013 showed the feasibility of this exploration in the three protagonists of the interaction: mother, preterm baby and reader.
- Conditions
- Premature Infant, Mother-Baby Synchrony
- Being tested
- Physiologically evaluate the impact of reading history on the mother-baby synchronies in a context of premature birth requiring hospitalization in neonatal medicine.
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiologically evaluate the impact of reading history on the mother-baby synchronies in a context of premature birth requiring hospitalization in neonatal medicine.Other
Physiologically evaluate the impact of reading history on the mother-baby synchronies in a context of premature birth requiring hospitalization in neonatal medicine.
| Study group | Role | What they receive |
|---|---|---|
| Babies born prematurely between 27 and 37 SA | Other | Not described Receives: Other: Physiologically evaluate the impact of reading history on the mother-baby synchronies in a context of premature birth requiring hospitalization in neonatal medicine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of cardio-respiratory synchronies and vagal tone
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start16 Jan 2017
- Primary completion29 Dec 2023
- Study completion29 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature InfantStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03114644
- Sponsor's protocol ID
- PI2014_843_0010
- Acronym
- SynchroPrema
- Status last verified
- Jun 2026
- First submitted
- 5 Apr 2017
- Last updated
- 11 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reading Stories to Premature Babies Reinforces Mother-baby Synchronies?
- ClinicalTrials.gov ID
- NCT03114644
- Acronym / sponsor ID
- SynchroPrema / PI2014_843_0010
- Conditions
- Premature Infant, Mother-Baby Synchrony
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 16 Jan 2017 (actual)
- Primary completion
- 29 Dec 2023 (actual)
- Study completion
- 29 Dec 2023 (actual)
- First posted
- 14 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Observations of the early interactions between the infant and his parents highlighted the existence of rhythmic and reciprocal communications that serve as a basis for the mother-baby relationship and the emotional and cognitive development of the baby.
Detailed description
Observations of the early interactions between the infant and his parents highlighted the existence of rhythmic and reciprocal communications that serve as a basis for the mother-baby relationship and the emotional and cognitive development of the baby. In this study, the investigator proposes to focus on premature births (before 37 years) because prematurity disrupts the synchronization of these mother-baby communication. For several years, reading of stories and nursery rhymes has been used by the liaison child psychiatry team in the neonatal medicine and pediatric intensive care unit of the University Hospital of Amiens, as a therapeutic mediation tool allowing And support for parent-child interactions. Thus, it is desirable to explore the impact of reading stories and rhymes on mother-baby synchronies. The study is innovative because it simultaneously explores several fields: physiological, neuroendocrine, cognitive and psychic. A pilot study carried out in 2013 showed the feasibility of this exploration in the three protagonists of the interaction: mother, preterm baby and reader.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Babies born prematurely between 27 and 37 SA | Other | Other: Physiologically evaluate the impact of reading history on the mother-baby synchronies in a context of premature birth requiring hospitalization in neonatal medicine. |
Who may qualify
- Ages
- 25 to 37 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- A premature birth between 27 and 37 SA
- At the time of the transfers, the latter must be hospitalized in intensive care and extubated
Key exclusion criteria (10 listed)
- an unstable medical condition
- Serious somatic complications
- genetic or neurological diseases
- a twin.
- an impossibility to understand and speak the French language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physiologically evaluate the impact of reading history on the mother-baby synchronies in a context of premature birth requiring hospitalization in neonatal medicine.Physiologically evaluate the impact of reading history on the mother-baby synchronies in a context of premature birth requiring hospitalization in neonatal medicine. | Other | Babies born prematurely between 27 and 37 SA |
Primary outcome
Analysis of cardio-respiratory synchronies and vagal tone
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiologically evaluate the impact of reading history on the mother-baby synchronies in a context of premature birth requiring hospitalization in neonatal medicine. in people with Premature Infant and Mother-Baby Synchrony, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of cardio-respiratory synchronies and vagal tone (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.