Assessing the mental state of parents with premature children
Assessment of the Mental State of Parents of Premature Children and Impact on Neurodevelopment of the Child (Parents Psychic Preterm)
University Hospital, Angers · NCT04827225
This study looks at the mental health of parents with premature babies to see how their feelings might change over time and affect their child's development.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Sex | All |
| Sponsor | University Hospital, Angers (other gov) |
| Locations | 1 site (Angers) |
| Trial ID | NCT04827225 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the psychological profiles of parents whose children are born prematurely, focusing on both mothers and fathers. It seeks to identify risk factors that may contribute to postpartum mental disorders such as anxiety, depression, and post-traumatic stress disorder. By utilizing questionnaires, the study will assess the evolution of parental mental health over time and its potential impact on the child's neurodevelopment and attachment. The research is conducted at the Angers University Hospital, targeting parents of premature infants hospitalized in their neonatology department.
Who should consider this trial
Good fit: Ideal candidates for this study are parents of singleton premature infants who are hospitalized in the neonatology department and can provide informed consent.
Not a fit: Parents of twins or multiple births, or those whose children have significant medical conditions, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the mental health needs of parents of premature children, leading to better support and interventions.
How similar studies have performed: While there is existing research on the mental health of parents of premature infants, this study's comprehensive approach to include both parents and assess the evolution of their mental state over time is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Angers
- CHU Angers — Angers, France (RECRUITING)
Study contacts
- Study coordinator: Géraldine GASCOIN, PU-PH
- Email: gegascoin@chu-angers.fr
- Phone: 02 41 35 44 07
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Parent-Child Relations, prematurity, psychic state