Effects of preterm birth on parental anxiety and child cognition
Impact of Preterm Birth on Symptoms of Anxiety and Depression in Parents, and on the Precursors of Cognition, Including Social Cognition in Their Child
This study looks at how having a baby born early affects parents' anxiety and depression, and how these feelings might impact their child's thinking and social skills.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | CHU de Reims Academic / other |
| Locations | 1 site (Reims) |
| Trial ID | NCT05734768 on ClinicalTrials.gov |
What this trial studies
This observational study examines the impact of preterm birth on the mental health of parents, specifically focusing on symptoms of anxiety and depression. It also investigates how these factors may influence the cognitive development and social cognition of their children. The study includes both parents of preterm infants and parents of term infants to compare outcomes. Participants will be recruited from the maternity ward of the University Hospital of Reims within 72 hours after birth.
Who should consider this trial
Good fit: Ideal candidates include parents of infants born preterm between 32 and 36 weeks of gestation, as well as parents of term infants born at the same hospital.
Not a fit: Patients whose infants are born from multiple pregnancies or are hemodynamically unstable will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the psychological challenges faced by parents of preterm infants and inform interventions to support their mental health.
How similar studies have performed: Other studies have indicated that parental anxiety and depression are significant issues following preterm birth, suggesting that this approach is relevant and necessary.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Children and their parents will be included in the study in the exposed group if: * the infant is born preterm, i.e., between 32 weeks of amenorrhea (SA) and 36 SA + 6 days. * at the maternity ward of the University Hospital of Reims * the parents are older than 18 years. * parents are affiliated to a social insurance. * parents agreed to participate in the study, within 72 hours after birth Will be included in the study, in the non-exposed group, children and their parents, if: * the children is born at term, i.e., from 37 SA + 0 Days * at the maternity ward of the Reims University Hospital * parents are older than 18 years. * parents are affiliated to a social insurance. * parents agreed to participate in the study, within 72 hours after birth Exclusion Criteria: Will not be included in the study, children and their parents, if: * the infant is born from multiple pregnancy * the infant is hemodynamically unstable * the birth occured more than 72 hours ago * the infant is affected by congenital malformations * the infant is affected by severe brain lesion detected by transfontanellar ultrasound scan performed before inclusion (cystic leukomalacia, and stages III and IV of the Papille classification i.e. severe ventricular dilatation or intra-parenchymal hemorrhage) * separation from the parents and placement of the child is intended * child is born anounymously * parents with psychiatric disorders * if the mother is suffering from hemodynamic compromise * parents under guardianship * parents non-native speaking
Where this trial is running
Reims
- Chu Reims — Reims, France (Recruiting)
Study contacts
- Study coordinator: Julien EUTROPE
- Email: jeutrope@chu-reims.fr
- Phone: 3 26 78 94 76
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.