Preterm ChildrenTERM-COGNCT03007095
Preterm Birth and Social Cognition
A study testing Evaluation of the children's social cognitive development in people with Preterm Children, run by CHU de Reims at 1 site in France.
Trial summary
The study aims at investigating social cognition outcomes of children born prematurely. Social cognition can be briefly defined as a process which underlines people's social and emotional behaviors. There are behavioral and cognitive evidences indicating that preterm children have executive dysfunctions. Read more about this study
- Who is it for?
- Ages 6 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Preterm Children
- What is being tested?
- Evaluation of the children's social cognitive development
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jul 2017to 31 Aug 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 6 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Preterm children:
- Girls or boys born before 37 weeks of gestational age.
- Aged between 7 to 10 years-old
- At school
- Term children:
- Girls or boys born after 37 weeks of gestational age.
- Aged between 6 and 10 years-old: 6 year-olds were included for the mental age matching with preterm children.
- At school
Who cannot join
- Children :
- Child with a intrauterine growth failure
- Child from multiple births
- Child with organic malformation
- Child with a genetic anomaly
- Child with a neuromoteur pathology
Show all 12Show fewer
- Child with a global developmental delay (Intellectual quotient inferior to 80).
- Parents :
- Minor parent (less than 18 year old)
- Parent with an intellectual disability
- Parent with a psychotic syndrome
- Parent who does not understand French
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preterm Birth and Social Cognition: of the Executive Functions and Parental Anxiety's Stakes
The study aims at investigating social cognition outcomes of children born prematurely. Social cognition can be briefly defined as a process which underlines people's social and emotional behaviors. There are behavioral and cognitive evidences indicating that preterm children have executive dysfunctions. Executive functions refer to multiple cognitive processes that contribute to human higher order abilities, such as purposeful and future-orientated behavior. The literature regarding development of term born children indicates that executive functions are linked to the emergence of social cognition. Then, the investigators asked if children born prematurely, as they commonly present executive dysfunctions, would show an atypical development of social cognition. Additionally, as it has been shown that parental anxiety is a key factor of preterm children development, the investigators assumed that it should play a role in social cognition outcomes.
Read the detailed description
The present study examines the social cognition development of very preterm children at 7 to 10 years old. In the literature, there has yet to be any research on social cognition of children born prematurely while preterm children are usually described as having difficulties in social relations. The main hypothesis is that preterm children would present a deficit or a delay in the social cognition development in comparison with that of matched term children, and that this deficit or delay should be explained by executive dysfunctions and parental anxiety.
Social cognition can be defined as the ability to understand the mind of other people and more specifically to perceive emotion, to have empathy, to attribute false-belief, to understand intended meaning, among others. In this study, the investigators will mainly focus on the ability of 80 very preterm children to understand the mind of others, well known as theory of mind in the literature, thanks to small stories involving the thinking and feelings of characters.
The executive functioning, which refers to multiple processes underlying human higher order abilities, will be assessed thanks to standardized neuropsychological tests. In this study, the investigators will focus on the three main well known executive functions: inhibition, working memory and shifting. They expect, consistently with the literature, that preterm children will have executive dysfunctions, and that these will be linked to children theory of mind abilities.
Finally, given that parental anxiety affects child development, the investigators plan to assess some psychological features of children's parents in our study, such the level of parental anxiety. They assume that this level will also be linked to theory of mind abilities of children.
- Conditions
- Preterm Children
- Being tested
- Evaluation of the children's social cognitive development
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of the children's social cognitive developmentBehavioural
standardized neuropsychological tests
| Study group | Role | What they receive |
|---|---|---|
| preterm children | Experimental | Not described Receives: Behavioral: Evaluation of the children's social cognitive development |
| term children | Active comparator | Not described Receives: Behavioral: Evaluation of the children's social cognitive development |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social cognition / Theory of mind
small stories involving the thoughts and feelings of characters
Measured: Day 0
working memory
Executives functions
Measured: Day 0
shifting
Executives functions
Measured: Day 0
Trait Anxiety Inventory
Parent's psychological features
Measured: Day 0
Beck Depression Inventory
Parent's psychological features
Measured: Day 0
Social Support Questionnaire
Parent's psychological features
Measured: Day 0
Trauma
Parent's psychological features
Measured: Day 0
Parental Stress Index
Parent's psychological features
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2017 (estimated)
- Study start20 Jul 2017
- Primary completion19 Jul 2023
- Study completion31 Aug 2023
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 Preterm ChildrenStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03007095
- Sponsor's protocol ID
- PO16068*
- Acronym
- TERM-COG
- Status last verified
- Oct 2023
- First submitted
- 27 Dec 2016
- Last updated
- 21 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Eutrope J, Novo A, Barbe C, Loron G, Rolland AC, Caillies S. Impact of Executive Functions and Parental Anxiety on the Development of Social Cognition in Premature Children: A Cross-Sectional Case-Control Protocol. Front Psychiatry. 2021 Sep 9;12:484571. doi: 10.3389/fpsyt.2021.484571. eCollection 2021.
PubMed 34566706
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preterm Birth and Social Cognition: of the Executive Functions and Parental Anxiety's Stakes
- ClinicalTrials.gov ID
- NCT03007095
- Acronym / sponsor ID
- TERM-COG / PO16068*
- Conditions
- Preterm Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 20 Jul 2017 (actual)
- Primary completion
- 19 Jul 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 2 Jan 2017 (estimated)
- 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.
The study aims at investigating social cognition outcomes of children born prematurely. Social cognition can be briefly defined as a process which underlines people's social and emotional behaviors. There are behavioral and cognitive evidences indicating that preterm children have executive dysfunctions. Executive functions refer to multiple cognitive processes that contribute to human higher order abilities, such as purposeful and future-orientated behavior. The literature regarding development of term born children indicates that executive functions are linked to the emergence of social cognition. Then, the investigators asked if children born prematurely, as they commonly present executive dysfunctions, would show an atypical development of social cognition. Additionally, as it has been shown that parental anxiety is a key factor of preterm children development, the investigators assumed that it should play a role in social cognition outcomes.
Detailed description
The present study examines the social cognition development of very preterm children at 7 to 10 years old. In the literature, there has yet to be any research on social cognition of children born prematurely while preterm children are usually described as having difficulties in social relations. The main hypothesis is that preterm children would present a deficit or a delay in the social cognition development in comparison with that of matched term children, and that this deficit or delay should be explained by executive dysfunctions and parental anxiety.
Social cognition can be defined as the ability to understand the mind of other people and more specifically to perceive emotion, to have empathy, to attribute false-belief, to understand intended meaning, among others. In this study, the investigators will mainly focus on the ability of 80 very preterm children to understand the mind of others, well known as theory of mind in the literature, thanks to small stories involving the thinking and feelings of characters.
The executive functioning, which refers to multiple processes underlying human higher order abilities, will be assessed thanks to standardized neuropsychological tests. In this study, the investigators will focus on the three main well known executive functions: inhibition, working memory and shifting. They expect, consistently with the literature, that preterm children will have executive dysfunctions, and that these will be linked to children theory of mind abilities.
Finally, given that parental anxiety affects child development, the investigators plan to assess some psychological features of children's parents in our study, such the level of parental anxiety. They assume that this level will also be linked to theory of mind abilities of children.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| preterm children | Experimental | Behavioral: Evaluation of the children's social cognitive development |
| term children | Active comparator | Behavioral: Evaluation of the children's social cognitive development |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Girls or boys born before 37 weeks of gestational age.
- Aged between 7 to 10 years-old
- At school
- Girls or boys born after 37 weeks of gestational age.
- Aged between 6 and 10 years-old: 6 year-olds were included for the mental age matching with preterm children.
Key exclusion criteria (12 listed)
- Children :
- Parents :
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 |
|---|---|---|
| Evaluation of the children's social cognitive developmentstandardized neuropsychological tests | Behavioural | preterm children, term children |
Primary outcome
Social cognition / Theory of mind
Time frame: Day 0
small stories involving the thoughts and feelings of characters
working memory
Time frame: Day 0
Executives functions
shifting
Time frame: Day 0
Executives functions
Trait Anxiety Inventory
Time frame: Day 0
Parent's psychological features
Beck Depression Inventory
Time frame: Day 0
Parent's psychological features
Social Support Questionnaire
Time frame: Day 0
Parent's psychological features
Trauma
Time frame: Day 0
Parent's psychological features
Parental Stress Index
Time frame: Day 0
Parent's psychological features
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 21 Jan 2026.
- Results publication: PubMed 34566706Eutrope J, Novo A, Barbe C, Loron G, Rolland AC, Caillies S. Impact of Executive Functions and Parental Anxiety on the Development of Social Cognition in Premature Children: A Cross-Sectional Case-Control Protocol. Front Psychiatry. 2021 Sep 9;12:484571. doi: 10.3389/fpsyt.2021.484571. eCollection 2021.
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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 Evaluation of the children's social cognitive development in people with Preterm Children, 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 8 inclusion and 12 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 21 Jan 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?
Social cognition / Theory of mind (time frame: Day 0). The study lists 8 primary outcomes in all. 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 NCT03007095, 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 21 Jan 2026.