Preterm Birth and Social Cognition

NCT03007095 | Completed

• 1 other identifier: PO16068*
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Preterm Children

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (2)

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

Interventions

Evaluation of the children's social cognitive development BEHAVIORAL

standardized neuropsychological tests

preterm children; term children

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Chu Reims

Reims, 51092, France

Location

Related Publications (1)

• 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.

  PMID: 34566706 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2016
• First Posted: January 2, 2017
• Study Start: July 20, 2017
• Primary Completion: July 19, 2023
• Study Completion: August 31, 2023
• Last Updated: January 21, 2026

Record last verified: 2023-10

Locations

FR (1)