Preterm Birth and Social Cognition (TERM-COG)

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.

Study Overview

• Status: Completed
• Conditions: Preterm Children
• Intervention / Treatment: Behavioral: Evaluation of the children's social cognitive development

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 Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Reims, France, 51092
    • CHU Reims

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 10 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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
  • 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: preterm children	Behavioral: Evaluation of the children's social cognitive development; standardized neuropsychological tests
Active Comparator: term children	Behavioral: Evaluation of the children's social cognitive development; standardized neuropsychological tests

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Social cognition / Theory of mind	small stories involving the thoughts and feelings of characters	Day 0
working memory	Executives functions	Day 0
shifting	Executives functions	Day 0
Trait Anxiety Inventory	Parent's psychological features	Day 0
Beck Depression Inventory	Parent's psychological features	Day 0
Social Support Questionnaire	Parent's psychological features	Day 0
Trauma	Parent's psychological features	Day 0
Parental Stress Index	Parent's psychological features	Day 0

Collaborators and Investigators

• Sponsor: CHU de Reims

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2017
• Primary Completion (Actual): July 19, 2023
• Study Completion (Actual): August 31, 2023

Study Registration Dates

• First Submitted: December 27, 2016
• First Submitted That Met QC Criteria: December 29, 2016
• First Posted (Estimated): January 2, 2017

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 19, 2026
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth
• Other Study ID Numbers: PO16068*

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No