Assessment of the Mental State of Parents of Premature Children and Impact on Neurodevelopment of the Child

NCT ID: NCT04827225

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

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-26

Study Completion Date

2026-08-26

Brief Summary

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The objective of the study is to assess the psychic profile of parents of children born prematurely

Detailed Description

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Prematurity affects aroound 1 in 10 children worlwide. Many studies have shown the role of prematurity in the development of depression, anxiety, post-traumatic stress disorder, mother-to-child attachment disorders, but few studies have sought to assess the evolution of this profile over time as well as to assess all of the parents' psychic dimensions.

The investigators currently have little knowledge of risk factors (psychological or psychiatric history, follow-up undertaken, treatments implemented, etc.) that may favor the occurrence of postpartum mental disorders (anxiety, depression, post-traumatic stress disorder ).

The investigators will thus seek to identify them. Prematurity can have a negative impact on the parents' psychic experience in the postpartum period. However, few studies have examined the evolution over time of the parental psychic profile and its possible repercussions on the child in terms of attachment and becoming neurodevelopmental. Finally, the majority of studies dealing with these subjects concern only mothers.Tthe investigators will endeavor here to also take into account the fathers.

Conditions

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Parent-Child Relations

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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PoPPY Group

Mother, Father and child born prematurely

questionnaires

Intervention Type BEHAVIORAL

Questionnaires (EPDS, HADS, PPQ, MIBS, etc.) will have to be completed by the parents at different stages of their child's development (38 weeks of amenorrhea, 3 months and 24 months).

Interventions

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questionnaires

Questionnaires (EPDS, HADS, PPQ, MIBS, etc.) will have to be completed by the parents at different stages of their child's development (38 weeks of amenorrhea, 3 months and 24 months).

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

Parents whose child meets the following criteria:

* Singleton child
* Child aged up to 40 weeks of amenorrhea of age corrected at the time of inclusion
* Premature child as defined below:

* Born at a term less than or equal to 34 weeks of amenorrhea And or
* weighing 1500g or less at birth
* Hospitalized in the neonatology department of the Angers University Hospital
* Child included in Réseau Grandir Ensemble (RGE) in Pays de la Loire
* Informed consent form signed by both parents for their participation and the collection of data from the RGE for the child


* Parents not fluent in the French language, implying not being able to complete the various questionnaires
* Parents including the child :

* Is from a twin pregnancy or more
* Has polymalformative syndrome or chromosomal abnormalities

Exclusion Criteria

\- Death of the child or one of the parents during follow-up
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

Locations

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CHU Angers

Angers, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Géraldine GASCOIN, PU-PH

Role: CONTACT

02 41 35 44 07

Elsa BERARDI

Role: CONTACT

02 41 35 61 79

Facility Contacts

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Géraldine GASCOIN, PU-PH

Role: primary

02 41 35 44 07

Elsa BERARDI

Role: backup

02 41 35 61 79

Other Identifiers

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49RC20_0132

Identifier Type: -

Identifier Source: org_study_id

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