AttachMent Preterm in the Loire Infant Follow-up Team

NCT ID: NCT04304846

Last Updated: 2024-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-07

Study Completion Date

2027-01-06

Brief Summary

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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

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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).

Conditions

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Preterm Birth

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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AMPLIFy group

Mother, premature child and teacher will complete questionnaires and interviews on attachment, maternal stress and child behavior

Questionnaires and interviews

Intervention Type OTHER

List of questionnaires: ASQ, PSI, PPQ, SDQ, GSA and AMMI score obtained from mother during two separated interviews for the mother and the child at 3 and 5 years old

Interventions

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Questionnaires and interviews

List of questionnaires: ASQ, PSI, PPQ, SDQ, GSA and AMMI score obtained from mother during two separated interviews for the mother and the child at 3 and 5 years old

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Angers

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elise Riquin, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Angers

Géraldine Gascoin, MD

Role: STUDY_DIRECTOR

University Hospital of Angers

Locations

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University Hospital of Angers

Angers, , France

Site Status RECRUITING

University Hospital of Nantes

Nantes, , France

Site Status NOT_YET_RECRUITING

Countries

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France

Central Contacts

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Denise Jolivot, MD

Role: CONTACT

33-2-41-35-58-08

Sybille Lazareff, CRA

Role: CONTACT

33-2-41-35-33-42

Facility Contacts

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Géraldine Gascoin, MD

Role: primary

Elise Riquin, MD

Role: backup

Jean-Baptiste Muller, MD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 35903159 (View on PubMed)

Other Identifiers

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49RC19_0132

Identifier Type: -

Identifier Source: org_study_id

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