NCT06627140 Expected and Actual Preterm-Birth and Parental Distress: Impact on Children's Mental Health
| NCT ID | NCT06627140 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Goethe University |
| Condition | Preterm Birth |
| Study Type | OBSERVATIONAL |
| Enrollment | 250 participants |
| Start Date | 2024-07-08 |
| Primary Completion | 2024-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 250 participants in total. It began in 2024-07-08 with a primary completion date of 2024-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of the present study is the assessment of the mental health and cognitive development of children 6-11 years after premature or term birth. Impairments in children's' mental health are assessed focusing different disorders or problems (ADHD, Autism traits, Affective disorders, oppositional-aggressive behavior) and using both questionnaires and a clinical interview. Risk and protective factors will be analyzed, e.g., threat and/or actual premature birth compared to term birth, parents' mental health, positive coping, personality traits and social support in the peripartum period and afterwards, as well as medical parameters. The potential interaction of premature birth, medical complications, parental distress and children's mental health will be taken into consideration.
Eligibility Criteria
Children and their parents must have participated in the previous study. Inclusion criteria of the previous study regarding the parents were: * Pregnant women and their partners from the 24th week of gestation on * 18 years of age Exclusion criteria of the previous study were: * Psychiatric, mainly psychotic diseases * Drug abuse * Severe neurological disorders * Stillbirth
Contact & Investigator
Katharina Szota, PhD
PRINCIPAL INVESTIGATOR
Johann Wolfgang Goethe University, Philipps-University Marburg
Frequently Asked Questions
Who can join the NCT06627140 clinical trial?
This trial is open to participants of all sexes, studying Preterm Birth. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06627140 currently recruiting?
Yes, NCT06627140 is actively recruiting participants. Contact the research team at szota@uni-marburg.de for enrollment information.
Where is the NCT06627140 trial being conducted?
This trial is being conducted at Frankfurt am Main, Germany.
Who is sponsoring the NCT06627140 clinical trial?
NCT06627140 is sponsored by Goethe University. The principal investigator is Katharina Szota, PhD at Johann Wolfgang Goethe University, Philipps-University Marburg. The trial plans to enroll 250 participants.