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

NCT04827225 | Active Not Recruiting

• 1 other identifier: 49RC20_0132
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Parent-Child Relations

Keywords

prematurity; psychic state

Outcome Measures

Primary Outcomes (3)

• Assessing the psychic profile of parents of children born prematurely

  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

  At 38 weeks of amenorrhea (+/- 2 weeks)

• Assessing the psychic profile of parents of children born prematurely

  The psychic profile of the parents will be evaluated from the score obtained in the following autoquestionnaire : \- parental anxiety (Hospital Anxiety and Depression Scale (HADS)), a score greater than or equal to 11 of the sub-scale anxiety is in favor of a parental anxiety

  At 38 weeks of amenorrhea (+/- 2 weeks)

• Assessing the psychic profile of parents of children born prematurely

  The psychic profile of the parents will be evaluated from the score obtained in the following autoquestionnaire : \- posttraumatic stress parental ( Perinatal Posttraumatic Stress disorder Questionnaire (PPQ)), a score greater than or equal to 6 is in favour of posttraumatic parental stress

  At 38 weeks of amenorrhea (+/- 2 weeks)

Secondary Outcomes (8)

• Study the evolution of parents' psychic profile over time

  At 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 the evolution of parents' psychic profile over time

  At 3 months corrected age and at 24 months corrected age

• Investigate the presence of peritraumatic dissociation experiments

  At 38 weeks of amenorrhea (+/- 2 weeks)

• Assess the mother's attachment to her child

  At 38 weeks of amenorrhea and 3 months corrected age of the child

Study Arms (1)

PoPPY Group

Mother, Father and child born prematurely

Behavioral: questionnaires

Interventions

questionnaires 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).

PoPPY Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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'.

You may qualify if:

• Parents whose child meets the following criteria:
• Singleton child
• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (2)

CHU Angers

Angers, France

Location

CHU Toulouse

Toulouse, France

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2020
• First Posted: April 1, 2021
• Study Start: October 26, 2020
• Primary Completion: April 26, 2024
• Study Completion (Estimated): August 26, 2026
• Last Updated: March 4, 2026

Record last verified: 2026-03

Locations

FR (2)