Clinical trial NCT04304846: AttachMent Preterm in the Loire Infant Follow-up Team
Official title: Attachment Representations of Children Born Prematurely in the Loire Infant Follow-up Team Cohort
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Preterm Birth
Keywords: Prematurity
Attachment
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2020-03-11
Enrollment: 90
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children born prematurely in the French region Pays de la Loire and included in the cohort 'Réseau Grandir Ensemble en Pays de la Loire'.

Brief summary: The purpose of this study is to describe the attachment representations of children born prematurely at age 3 and 5 with regard to their neurocognitive and behavioral development.

Detailed description: Whether they are born at term or prematurely, from birth, children seek contact with caregivers and establish privileged relationships with them. These attachment relationships are gradually established and, from the end of the first year, interindividual differences can be observed according to temperament, quality of interactions with adults and responses to children's needs for proximity and comfort.

Prematurity is a situation that can disrupt parent-child interactions. The physiological characteristics of the premature infant attenuate and distort his/her stress signals. Visual interactions are shorter, alertness is more labile and reactivity is less clear than that of babies born at term. In such situations of stress and trauma, maternal sensitivity and responsiveness can be affected. In addition, changes in the quality of mother-child interactions have been reported, with more controlling maternal behavior. This maternal trend has been associated with behavioral disorders in children, such as eating disorders or lack of interest in social communication. More frequent disruptions of maternal caregiving associated with relational withdrawal in the child have also been shown in the case of prematurity.

We hypothesize that the experience of establishing relationships with parents in a context of extreme prematurity can alter the development of secure attachment representations in the child and that maternal representations and their possible interactions with prematurity factors prevent or contribute to the development of insecure or disorganized attachment in the child. We also hypothesize that disorganized attachment representations are associated with somatic, environmental, affective, and neurodevelopmental complications (motor, cognitive and behavioral).

Eligibility criteria: Inclusion Criteria:

* Children born in the neonatal reanimation department of Angers and Nantes University Hospitals
* Extrem preterm infants (term of birth less than or equal to 28 weeks of amenorrhea)
* Children included in the regional monitoring network for vulnerable newborns (Réseau Grandir Ensemble en Pays de la Loire, RGE)
* Children with a follow-up consultation at age 3 scheduled as part of the classic RGE follow-up on the Angers and Nantes University Hospitals
* Informed consent dated and signed by the parents or the holder of the parental authority
* Affiliated to a Social Security scheme

Exclusion Criteria:

* Child with severe neurocognitive impairment or severe autism trait-type behavioral disorder in the 2-year RGE follow-up evaluation

Primary outcomes:
measure: Attachment Story Completion Task
timeFrame: Three and five years after preterm birth
Secondary outcomes:
measure: Attachment Multiple Model Interview (AMMI)
timeFrame: Three and five years after preterm birth
measure: Parenting Stress Index (PSI) Scale
timeFrame: Three and five years after preterm birth
measure: Post-traumatic stress disorder Questionnaire (PPQ)
timeFrame: Three and five years after preterm birth
measure: Ages and Stages Questionnaires® (AQS) Questionnaires
timeFrame: Three and five years after preterm birth
measure: Strengths and Difficulties Questionnaire (SDQ)
timeFrame: Three and five years after preterm birth
measure: Global School Adaptation (GSA) Score
timeFrame: Five years after preterm birth
Other outcomes:
Locations:
city: Angers
country: France
facility: University Hospital of Angers
city: Nantes
country: France
facility: University Hospital of Nantes
Study officials:
affiliation: University Hospital of Angers
name: Elise Riquin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Angers
name: Géraldine Gascoin, MD
role: STUDY_DIRECTOR
References:
citation: Riquin E, Sandnes R, Bacro F, Vinay A, Miljkovitch R, Rouger V, Rakotonjanahary J, Gascoin G, Muller JB. A Prospective Observational Study to Assess Attachment Representations With Regard to Neurocognitive and Behavioral Outcomes in Children Born Very Prematurely in the Loire Infant Follow-Up Team (LIFT Cohort). Front Pediatr. 2022 Jul 13;10:896103. doi: 10.3389/fped.2022.896103. eCollection 2022.