Preterm Birth
Conditions
Keywords
preterm born children, ehealth, development, somatic and mental problems, interdisciplinary care
Brief summary
The aim of the study is to assess mental and somatic symptoms of preterm born children at the ages of 2, 5 and 10 by a multidisciplinary team and to evaluate an app that screens for these symptoms. Furthermore, there will be an evaluation of an intervention by our multidisciplinary team that provides recommendations for further treatment and diagnostic procedures of the children.
Detailed description
* At first, there will be focus groups with experts and affected families to finalize and optimize the study procedure. After that, 90 children will be recruited (ages 2, 5 and 10) * T0: App-questions for the children at the ages of 5 and 10 and the parents of all children to mental, somatic and sleep problems of the children and well-being of the parents, sleep tracking and recording of a sleep sequence of the children; differentiated examinations and questionnaires to mental and somatic problems of the children by interdisciplinary study team * Interdisciplinary study team meeting to generate recommendations for the families * Interdisciplinary study team recommendations for the families * T1: Comparable to T0 but only measurements that were assessed with questionnaires/at home plus post-experimental questionnaire * Focus groups with participating families and the study team experts for evaluation of the study procedure and intervention
Interventions
OTHERDiagnostics and intervention recommendations
All families get the same diagnostics and receive individual treatment recommendations.
Sponsors
University Hospital Tuebingen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 10 Years
Healthy volunteers
Yes
Inclusion criteria
* female and male preterm born children (\<32 week of pregnancy) that are treated at the clinic in Tübingen and their parents * Existence of systematical neonatal data and consent of the care person to use this data * Existence of the data of the 2 year regular follow-up (for the 5 and 10 year olds)
Exclusion criteria
* lack of access to a mobile phone/tablet including internet access * insufficient knowledge of the German language of both parents
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bayley Scales of Infant and Toddler Development | Baseline | IQ testing |
| Wechsler Intelligence Scale for Children (WISC-V) | Baseline | IQ testing |
| Children's Sleep Habit Questionnaire (CSHQ-DE 4-10) | Baseline and 36-38 weeks after baseline | Screening of sleeping behaviour |
| Sleep Self Report (SSR) | Baseline and 36-38 weeks after baseline | Screening of sleeping behaviour |
| Somatics | Baseline and 36-38 weeks after baseline | Questions to somatic symptoms (diagnoses, inpatient stays, medication, early support) physical therapy, hearing impairment or visual disturbance, pulmonary symptoms, seizure disorders, health related quality of life, body weight, size) |
| Child Behavior Checklist (CBCL) | Baseline and 36-38 weeks after baseline | Screening for mental illness |
| Youth Self Report (YSR) | Baseline and 36-38 weeks after baseline | Screening for mental illness |
| Diagnostic-system for mental illness for children and adolescents - III (DISYPS-III SCREEN FBB and SBB) | Baseline and 36-38 weeks after baseline | Screening for mental illness |
| KIDSCREEN-27 (The KIDSCREEN) | Baseline and 36-38 weeks after baseline | Health related quality of life |
| Parent's Stress Inventory (EBI) | Baseline and 36-38 weeks after baseline | Load as parents and relationship to the child |
| App-questions | Baseline and 36-38 weeks after baseline | Questions reflecting the questionnaires |
| Postexperimental questionnaire | 36-38 weeks after baseline | Evaluation of the study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Demographic data | Baseline | age, gender, ethnicity, perinatal data from previous study participation |
| Actigraphy measurement | Baseline | Device that the children are wearing at their wrists |
| Video of a sleeping sequence | Baseline | The parents are taking a short video sequence of their sleeping child |
| Sleep cartoon for children | Baseline and 36-38 weeks after baseline | Cartoon sleep behavior |
| Kiddie-Sads-Present and Lifetime Version (K-SADS PL) | Baseline | Screening mental Illness |
| Self efficacy dealing with social situations (WIRKSOZ) | Baseline and 36-38 weeks after baseline | Self-efficacy measurement for social situations in children |
| Group interviews | Baseline and 36-38 weeks after baseline | Group interviews with experts and families to get feedback about the study procedure and needs |
Countries
Germany
Contacts
PRINCIPAL_INVESTIGATORAnnette Conzelmann, Prof. Dr.
University Hospital Tuebingen
PRINCIPAL_INVESTIGATORAxel Franz, Prof. Dr.
University Hospital Tuebingen
PRINCIPAL_INVESTIGATORMirja Quante, Dr.
University Hospital Tuebingen
PRINCIPAL_INVESTIGATORÁndrea Bevot, Dr.
University Hospital Tuebingen
PRINCIPAL_INVESTIGATORTobias Renner, Prof. Dr.
University Hospital Tuebingen
Outcome results
None listed