Parent-Child RelationsPoPPYNCT04827225
Assessment of the Mental State of Parents of Premature Children and Impact on Neurodevelopment of the Child
An observational study of Parent-Child Relations, run by University Hospital, Angers at 2 sites in France.
Trial summary
The objective of the study is to assess the psychic profile of parents of children born prematurely Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parent-Child Relations
- What is being tested?
- questionnaires
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 300 participants
- Where
- 2 sitesFrance
- Study dates
- 26 Oct 2020to 26 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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'.
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- Death of the child or one of the parents during follow-up
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Assessment of the Mental State of Parents of Premature Children and Impact on Neurodevelopment of the Child (Parents Psychic Preterm)
The objective of the study is to assess the psychic profile of parents of children born prematurely
Read the 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.
- Conditions
- Parent-Child Relations
- Being tested
- questionnaires
- Keywords
- prematurity, psychic state
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnairesBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| PoPPY Group | Mother, Father and child born prematurely Receives: Behavioral: questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: At 38 weeks of amenorrhea (+/- 2 weeks)
Secondary outcomes (8)
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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 24 months corrected age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start26 Oct 2020
- Primary completion26 Apr 2024
- Study completion26 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parent-Child RelationsStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04827225
- Sponsor's protocol ID
- 49RC20_0132
- Acronym
- PoPPY
- Status last verified
- Mar 2026
- First submitted
- 1 Sep 2020
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Mental State of Parents of Premature Children and Impact on Neurodevelopment of the Child (Parents Psychic Preterm)
- ClinicalTrials.gov ID
- NCT04827225
- Acronym / sponsor ID
- PoPPY / 49RC20_0132
- Conditions
- Parent-Child Relations
- Keywords
- prematurity, psychic state
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 26 Oct 2020 (actual)
- Primary completion
- 26 Apr 2024 (actual)
- Study completion
- 26 Aug 2026 (estimated)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PoPPY Group | – | Behavioral: questionnairesMother, Father and child born prematurely |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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'.
Key inclusion criteria (14 listed)
- Singleton child
- Child aged up to 40 weeks of amenorrhea of age corrected at the time of inclusion
- Premature child as defined below:
- Hospitalized in the neonatology department of the Angers University Hospital
- Child included in Réseau Grandir Ensemble (RGE) in Pays de la Loire
Key exclusion criteria (1 listed)
- Death of the child or one of the parents during follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnairesQuestionnaires (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). | Behavioural | PoPPY Group |
Primary outcome
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
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 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
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 : - posttraumatic stress parental ( Perinatal Posttraumatic Stress disorder Questionnaire (PPQ)), a score greater than or equal to 6 is in favour of posttraumatic parental stress
8 secondary outcomes
Study the evolution of parents' psychic profile over time
Time frame: At 3 months corrected age and at 24 months corrected age
Study the evolution of parents' psychic profile over time
Time frame: At 3 months corrected age and at 24 months corrected age
Study the evolution of parents' psychic profile over time
Time frame: At 3 months corrected age and at 24 months corrected age
Investigate the presence of peritraumatic dissociation experiments
Time frame: At 38 weeks of amenorrhea (+/- 2 weeks)
Assess the mother's attachment to her child
Time frame: At 38 weeks of amenorrhea and 3 months corrected age of the child
Assess the parental stress
Time frame: At 24 months corrected age
study perinatal or prenatal psychological and psychiatric factors associated with depression, anxiety and post traumatic stress
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
Time frame: At 24 months corrected age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parent-Child Relations, run by University Hospital, Angers at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing the psychic profile of parents of children born prematurely (time frame: At 38 weeks of amenorrhea (+/- 2 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.