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Recruiting NCT04304846

AttachMent Preterm in the Loire Infant Follow-up Team

Observational Preterm Birth

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Questionnaires and interviews.
Who it may be relevant to
Registry conditions: Preterm Birth. Basic parameters: 3 years — 6 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Attachment Representations of Children Born Prematurely in the Loire Infant Follow-up Team Cohort

Overview

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).

Interventions

  • Other 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

Primary outcome measures

  • Attachment Story Completion Task [Time frame: Three and five years after preterm birth]
Secondary outcome measures (6)
  • Attachment Multiple Model Interview (AMMI) [Time frame: Three and five years after preterm birth]
  • Parenting Stress Index (PSI) Scale [Time frame: Three and five years after preterm birth]
  • Post-traumatic stress disorder Questionnaire (PPQ) [Time frame: Three and five years after preterm birth]
  • Ages and Stages Questionnaires® (AQS) Questionnaires [Time frame: Three and five years after preterm birth]
  • Strengths and Difficulties Questionnaire (SDQ) [Time frame: Three and five years after preterm birth]
  • Global School Adaptation (GSA) Score [Time frame: Five years after preterm birth]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

France · 2 centers
  • University Hospital of Angers — Angers
  • University Hospital of Nantes — Nantes

Publications

  • 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. PMID 35903159

Identifiers

NCT: NCT04304846 · 49RC19_0132

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗