E-health support for families of preterm born children
E-health-supported Recording of Psychological and Somatic Problems, Risk and Resilience Factors of Premature Born Infants and Their Families and Individualized, Interdisciplinary Stepped-care Approach
NA · University Hospital Tuebingen · NCT06939192
This study is testing whether an app can help families of premature babies by providing support and information to improve their care after leaving the hospital.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 28 Weeks to 34 Weeks |
| Sex | All |
| Sponsor | University Hospital Tuebingen (other) |
| Locations | 1 site (Tübingen, Baden-Wurttemberg) |
| Trial ID | NCT06939192 on ClinicalTrials.gov |
What this trial studies
This project focuses on improving the post-hospital care of families with premature babies by utilizing an app-based diagnostic and support approach. It aims to identify risk and protective factors affecting the psychological and physical outcomes of preterm infants and their families. The study involves a longitudinal design with an experimental group receiving the app intervention and a control group receiving treatment as usual. Participants will be monitored at multiple time points after hospital discharge to assess the effectiveness of the intervention and gather qualitative feedback through focus groups.
Who should consider this trial
Good fit: Ideal candidates include premature infants born between 28-34 weeks of gestation and their mothers who are at least 18 years old and can communicate in German.
Not a fit: Patients who are born before 28 weeks or after 34 weeks of gestation, or those with serious health issues, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the resilience and overall well-being of preterm born children and their families.
How similar studies have performed: Other studies have shown promise in using e-health interventions for similar populations, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Premature babies born at the UKT, * Gestational age 28-34 weeks, * Mother: age ≥ 18 years, * agreement to participate in this study and signing of a consent form, * sufficient knowledge of German, * internet access Exclusion Criteria: * Premature babies \< 28th or \>34th week of pregnancy, * at least one of the children has serious diseases of the nervous system or obvious symptoms of a nervous disease, * at least one of the children has serious congenital diseases or suffers from malformations, * Mother: Lack of access to a smartphone/tablet, * no internet access, * insufficient knowledge of German
Where this trial is running
Tübingen, Baden-Wurttemberg
- University Hospital Tuebingen — Tübingen, Baden-Wurttemberg, Germany (RECRUITING)
Study contacts
- Principal investigator: Annette Conzelmann, Prof. Dr. — Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University of Tübingen
- Study coordinator: Annette Conzelmann, Prof.Dr.
- Email: annette.conzelmann@med.uni-tuebingen.de
- Phone: 00497071/29-87513
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: Preterm Birth, Preterm birth, E-health, Risk factors, Protective factors, Prevention