An observational study in Parent-Child Relations, sponsored by University Hospital, Angers. Active, not recruiting at 2 sites in France. Per ClinicalTrials.gov, last updated 2026-03-04.
Sponsored by University Hospital, Angers · Observational
The objective of the study is to assess the psychic profile of parents of children born prematurely
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.
2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.
This study's planned enrollment of 300 is above the median of 112 across 777 observational studies indexed under Premature Birth.
Browse Premature Birth studies →University Hospital, Angers is the lead sponsor of 464 studies on the registry; 116 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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'.
Parents whose child meets the following criteria:
Premature child as defined below:
Non-inclusion Criteria:
Parents including the child :
Exclusion Criteria:
- Death of the child or one of the parents during follow-up
Mother, Father and child born prematurely
Behavioral: 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).
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
Time frame: 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
Time frame: 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
Time frame: At 38 weeks of amenorrhea (+/- 2 weeks)
Study the evolution of parents' psychic profile over time
Use of the same tools and criteria as at 38 weeks of amenorrhea (parental depression : score EPDS ≥ 10)
Time frame: At 3 months corrected age and at 24 months corrected age
Study the evolution of parents' psychic profile over time
Use of the same tools and criteria as at 38 weeks of amenorrhea (parental anxiety HADS ≥11)
Time frame: At 3 months corrected age and at 24 months corrected age
Study the evolution of parents' psychic profile over time
Use of the same tools and criteria as at 38 WA (posttraumatic stress parental : PPQ ≥ 6)
Time frame: At 3 months corrected age and at 24 months corrected age
Investigate the presence of peritraumatic dissociation experiments
A score greater than 15 from the PDEQ (Peritraumatic Dissociative Experiences Questionnaire) is considered a score in favour of a significant traumatic dissociation. Minimum scale value : 10, full scale value : 50. Abnormal if greater than or equal to 15.
Time frame: At 38 weeks of amenorrhea (+/- 2 weeks)
Assess the mother's attachment to her child
A score equal to or greater than 2 from the MIBS questionnaire (Mother To Infant Bonding Scale) highlights mother-child disorders. This questionnaire is given only to the mother. Minimum scale value : 0, full scale value : 24. Abnormal if greater than or equal to 2.
Time frame: At 38 weeks of amenorrhea and 3 months corrected age of the child
Assess the parental stress
A PSI (Parenting Stress Index) high score (percentile rank greater than or equal to 85) is considered a score in favour af a parental stress. Minimum scale value : 0, full scale value : 180. Abnormal if greater than or equal to 85.
Time frame: At 24 months corrected age
study perinatal or prenatal psychological and psychiatric factors associated with depression, anxiety and post traumatic stress
these factors are studied by assessing whether or not there is a psychological and / or psychiatric history, medical-psychological follow-up, treatments taken.
Time frame: at 38 weeks of amenorrhea (+/- 2 weeks), and 3 months corrected age and at 24 months corrected age
Study the impact of the parental psychic profile on the neurological development of the child
A ASQ (Ages Stages Questionnaire) score less than 185 is considered not optimal. The other data collected during the evaluation of the 24 months of age corrected as part of the Réseau Grandir Ensemble (RGE) will be used for the evaluation of neurological development. These data make it possible to classify children's development into optimal or non-optimal according to a rating system which has been defined by the network's scientific council.The impact of the parental psychic profile (at 38 WA +/- 2 weeks, at 3 months and at 24 months of their child's corrected age) on neurological development will be evaluated by Odds Ratios (ORs): ORs measuring the association between the parental psychic profile and the non-optimal ASQ score, ORs measuring the association between the parental psychic profile and the non-optimal development category according to the RGE rating.
Time frame: At 24 months corrected age
This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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University Hospital, Angers