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Clinical Trials/NCT04827225
NCT04827225
Active, not recruiting
Not Applicable

Assessment of the Mental State of Parents of Premature Children and Impact on Neurodevelopment of the Child (Parents Psychic Preterm)

University Hospital, Angers2 sites in 1 country300 target enrollmentOctober 26, 2020

Overview

Phase
Not Applicable
Intervention
questionnaires
Conditions
Parent-Child Relations
Sponsor
University Hospital, Angers
Enrollment
300
Locations
2
Primary Endpoint
Assessing the psychic profile of parents of children born prematurely
Status
Active, not recruiting
Last Updated
last month

Overview

Brief Summary

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

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
October 26, 2020
End Date
August 26, 2026
Last Updated
last month
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Angers
Responsible Party
Sponsor

Eligibility Criteria

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
  • Non-inclusion Criteria:

Exclusion Criteria

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

Arms & Interventions

PoPPY Group

Mother, Father and child born prematurely

Intervention: questionnaires

Outcomes

Primary Outcomes

Assessing the psychic profile of parents of children born prematurely

Time Frame: At 38 weeks of amenorrhea (+/- 2 weeks)

The psychic profile of the parents will be evaluated from the score obtained in the following autoquestionnaire : \- parental depression (Edinburgh Postnatal Depression Scale (EPDS)), a score greater than or equal to 10 is in favour of parental depression

Secondary Outcomes

  • Assess the parental stress(At 24 months corrected age)
  • Investigate the presence of peritraumatic dissociation experiments(At 38 weeks of amenorrhea (+/- 2 weeks))
  • Study the impact of the parental psychic profile on the neurological development of the child(At 24 months corrected age)
  • Assess the mother's attachment to her child(At 38 weeks of amenorrhea and 3 months corrected age of the child)
  • study perinatal or prenatal psychological and psychiatric factors associated with depression, anxiety and post traumatic stress(at 38 weeks of amenorrhea (+/- 2 weeks), and 3 months corrected age and at 24 months corrected age)
  • Study the evolution of parents' psychic profile over time(At 3 months corrected age and at 24 months corrected age)

Study Sites (2)

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