Clinical trial NCT04827225: Assessment of the Mental State of Parents of Premature Children and Impact on Neurodevelopment of the Child
Official title: Assessment of the Mental State of Parents of Premature Children and Impact on Neurodevelopment of the Child (Parents Psychic Preterm)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Parent-Child Relations
Keywords: prematurity
psychic state
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2021-04-01
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children born prematurely hospitalizes in the neonatalogy department of the Angers University Hospital and included in the cohort 'Réseau Grandir Ensemble en Pays de la Loire'.

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.

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:

* 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

Primary outcomes:
measure: Assessing the psychic profile of parents of children born prematurely
timeFrame: At 38 weeks of amenorrhea (+/- 2 weeks)
measure: Assessing the psychic profile of parents of children born prematurely
timeFrame: At 38 weeks of amenorrhea (+/- 2 weeks)
measure: Assessing the psychic profile of parents of children born prematurely
timeFrame: At 38 weeks of amenorrhea (+/- 2 weeks)
Secondary outcomes:
measure: Study the evolution of parents' psychic profile over time
timeFrame: At 3 months corrected age and at 24 months corrected age
measure: Study the evolution of parents' psychic profile over time
timeFrame: At 3 months corrected age and at 24 months corrected age
measure: Study the evolution of parents' psychic profile over time
timeFrame: At 3 months corrected age and at 24 months corrected age
measure: Investigate the presence of peritraumatic dissociation experiments
timeFrame: At 38 weeks of amenorrhea (+/- 2 weeks)
measure: Assess the mother's attachment to her child
timeFrame: At 38 weeks of amenorrhea and 3 months corrected age of the child
measure: Assess the parental stress
timeFrame: At 24 months corrected age
measure: study perinatal or prenatal psychological and psychiatric factors associated with depression, anxiety and post traumatic stress
timeFrame: at 38 weeks of amenorrhea (+/- 2 weeks), and 3 months corrected age and at 24 months corrected age
measure: Study the impact of the parental psychic profile on the neurological development of the child
timeFrame: At 24 months corrected age
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
Study officials:
References: