Very Preterm BirthCALINNCT04380051
Evaluation of a Sensory-tonic Stimulation on Development of Parent-infant Interactions and Social Cognition in Very Premature Children
A study testing sensory-tonic stimulation and skin-to-skin contact in people with Very Preterm Birth, run by CHU de Reims at 1 site in France.
Trial summary
Attachment is built primarily on the first interactions of the first 9 months of a baby's life. These first interactions and their effects of stress, pleasure and displeasure are retained to establish some of the baby's attachment behaviours and future relationships with others. Read more about this study
- Who is it for?
- Ages Up to 1 day
- Conditions the study is for
- Very Preterm Birth
- What is being tested?
- sensory-tonic stimulation and skin-to-skin contact
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jan 2023to 19 Jan 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Up to 1 day
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- very preterm child (born before 32 weeks of amenorrhoea)
- parents agreeing to participate to the study
Who cannot join
- child born before 25 weeks of amenorrhoea
- child with a birth weight less than 600 grams
- child with congenital malformation
- child with hemodynamic instability
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Chu Reims
Reims, 51092
Damien JOLLY, 326788472 ext. 33, djolly@chu-reims.fr
About this study
Official title: Evaluation of a Sensory-tonic Stimulation on Development of Parent-infant Interaction and Social Cognition in Very Premature Children
Attachment is built primarily on the first interactions of the first 9 months of a baby's life. These first interactions and their effects of stress, pleasure and displeasure are retained to establish some of the baby's attachment behaviours and future relationships with others.
Extreme prematurity strongly modify these first interactions between parents and child. Very preterm child is separated from his parents and is placed in a stressful, technical and potentially painful environment.
Early interventions stimulate neuroplasticity and can positively affect the neurological development of very preterm infant. Tactile stimuli such as skin-to-skin contact and massages carried out by parents can be pleasant experiences that can support early interactions between parents and child.
Read the detailed description
The aim of the study is to evaluate impact of a sensory-tonic stimulation on development of parent-infant interaction and on social cognition in very premature children.
- Conditions
- Very Preterm Birth
- Being tested
- sensory-tonic stimulation, skin-to-skin contact
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sensory-tonic stimulationBehavioural
sensory-tonic stimulation done by the parents to the child, five times a week during 15 minutes at each time
skin-to-skin contactBehavioural
skin-to-skin contact left free for parents
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 : skin-to-skin contact associated with a sensory-tonic s | Experimental | skin-to-skin contact left free for parents associated with a sensory-tonic stimulation five times a week during 15 minutes at each time Receives: Behavioral: sensory-tonic stimulation; Behavioral: skin-to-skin contact |
| Arm 2 : skin-to-skin contact only | Active comparator | skin-to-skin contact left free for parents Receives: Behavioral: skin-to-skin contact |
What is being measured
The primary outcome is the main question the study is designed to answer.
interactions between parents and child
Two free play sequences of 15 minutes will be filmed. The Coding Interactive Behavior (CIB; Feldman, 1998) contains 43 items (22 relating to parents, 16 relating to child and 5 related to parent-child dyad. Each item is rated from 1 (a little) to 5 (a lot). The Coding Interactive Behavior has 6 dimensions. The dimension "social commitment of the child" will be the primary outcome for this study.
Measured: 12 months
Secondary outcomes (1)
Social cognition / Theory of mind
small stories involving the thinking and feelings of character
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2020
- Study start19 Jan 2023
- Primary completion19 Jan 2027 (estimated)
- Study completion19 Jan 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Very Preterm BirthStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- participants are assigned to one of two or more groups in parallel for the duration of the study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04380051
- Sponsor's protocol ID
- PR20064*
- Acronym
- CALIN
- Status last verified
- Feb 2026
- First submitted
- 5 May 2020
- Last updated
- 19 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Guittard C, Novo A, Eutrope J, Gower C, Barbe C, Bednarek N, Rolland AC, Caillies S, Loron G. Protocol for a prospective multicenter longitudinal randomized controlled trial (CALIN) of sensory-tonic stimulation to foster parent child interactions and social cognition in very premature infants. Front Pediatr. 2023 Jan 16;10:913396. doi: 10.3389/fped.2022.913396. eCollection 2022.
PubMed 36727004
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Sensory-tonic Stimulation on Development of Parent-infant Interaction and Social Cognition in Very Premature Children
- ClinicalTrials.gov ID
- NCT04380051
- Acronym / sponsor ID
- CALIN / PR20064*
- Conditions
- Very Preterm Birth
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 19 Jan 2023 (actual)
- Primary completion
- 19 Jan 2027 (estimated)
- Study completion
- 19 Jan 2033 (estimated)
- First posted
- 8 May 2020 (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.
Attachment is built primarily on the first interactions of the first 9 months of a baby's life. These first interactions and their effects of stress, pleasure and displeasure are retained to establish some of the baby's attachment behaviours and future relationships with others.
Extreme prematurity strongly modify these first interactions between parents and child. Very preterm child is separated from his parents and is placed in a stressful, technical and potentially painful environment.
Early interventions stimulate neuroplasticity and can positively affect the neurological development of very preterm infant. Tactile stimuli such as skin-to-skin contact and massages carried out by parents can be pleasant experiences that can support early interactions between parents and child.
Detailed description
The aim of the study is to evaluate impact of a sensory-tonic stimulation on development of parent-infant interaction and on social cognition in very premature children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- participants are assigned to one of two or more groups in parallel for the duration of the study
| Arm | Type | Receives |
|---|---|---|
| Arm 1 : skin-to-skin contact associated with a sensory-tonic s | Experimental | Behavioral: sensory-tonic stimulation, Behavioral: skin-to-skin contactskin-to-skin contact left free for parents associated with a sensory-tonic stimulation five times a week during 15 minutes at each time |
| Arm 2 : skin-to-skin contact only | Active comparator | Behavioral: skin-to-skin contactskin-to-skin contact left free for parents |
Who may qualify
- Ages
- Up to 1 day
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- very preterm child (born before 32 weeks of amenorrhoea)
- parents agreeing to participate to the study
Key exclusion criteria (4 listed)
- child born before 25 weeks of amenorrhoea
- child with a birth weight less than 600 grams
- child with congenital malformation
- child with hemodynamic instability
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 |
|---|---|---|
| sensory-tonic stimulationsensory-tonic stimulation done by the parents to the child, five times a week during 15 minutes at each time | Behavioural | Arm 1 : skin-to-skin contact associated with a sensory-tonic s |
| skin-to-skin contactskin-to-skin contact left free for parents | Behavioural | Arm 1 : skin-to-skin contact associated with a sensory-tonic s, Arm 2 : skin-to-skin contact only |
Primary outcome
interactions between parents and child
Time frame: 12 months
Two free play sequences of 15 minutes will be filmed. The Coding Interactive Behavior (CIB; Feldman, 1998) contains 43 items (22 relating to parents, 16 relating to child and 5 related to parent-child dyad. Each item is rated from 1 (a little) to 5 (a lot). The Coding Interactive Behavior has 6 dimensions. The dimension "social commitment of the child" will be the primary outcome for this study.
1 secondary outcome
Social cognition / Theory of mind
Time frame: 6 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Derived from this study: PubMed 36727004Guittard C, Novo A, Eutrope J, Gower C, Barbe C, Bednarek N, Rolland AC, Caillies S, Loron G. Protocol for a prospective multicenter longitudinal randomized controlled trial (CALIN) of sensory-tonic stimulation to foster parent child interactions and social cognition in very premature infants. Front Pediatr. 2023 Jan 16;10:913396. doi: 10.3389/fped.2022.913396. eCollection 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Very Preterm Birth
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Serial Brain MRI in Hospitalized Preterm Infants
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sensory-tonic stimulation and skin-to-skin contact in people with Very Preterm Birth, run by CHU de Reims 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 4 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: looking for participants now, as of the sponsor's last update on 19 Feb 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gauthier Loron (0326787878, gloron@chu-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
interactions between parents and child (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04380051, which also lists 1 linked publication.
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 19 Feb 2026.