Interdisciplinary, E-health Based, Multimodal Follow-up of Somatic, Sleep-related and Psychological Symptoms of Very Immature Preterm Born Babies in Different Age Groups for the Further Development of Previous Care Structures
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Preterm Birth
- Sponsor
- University Hospital Tuebingen
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Youth Self Report (YSR)
- Status
- Recruiting
- Last Updated
- last year
Overview
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
Investigators
PD Dr. Annette Conzelmann
Principal Investigator
University Hospital Tuebingen
Eligibility Criteria
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
Outcomes
Primary Outcomes
Youth Self Report (YSR)
Time Frame: Baseline and 36-38 weeks after baseline
Screening for mental illness
Bayley Scales of Infant and Toddler Development
Time Frame: Baseline
IQ testing
Sleep Self Report (SSR)
Time Frame: Baseline and 36-38 weeks after baseline
Screening of sleeping behaviour
Child Behavior Checklist (CBCL)
Time Frame: Baseline and 36-38 weeks after baseline
Screening for mental illness
Parent's Stress Inventory (EBI)
Time Frame: Baseline and 36-38 weeks after baseline
Load as parents and relationship to the child
KIDSCREEN-27 (The KIDSCREEN)
Time Frame: Baseline and 36-38 weeks after baseline
Health related quality of life
Wechsler Intelligence Scale for Children (WISC-V)
Time Frame: Baseline
IQ testing
Somatics
Time Frame: 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)
App-questions
Time Frame: Baseline and 36-38 weeks after baseline
Questions reflecting the questionnaires
Children's Sleep Habit Questionnaire (CSHQ-DE 4-10)
Time Frame: Baseline and 36-38 weeks after baseline
Screening of sleeping behaviour
Diagnostic-system for mental illness for children and adolescents - III (DISYPS-III SCREEN FBB and SBB)
Time Frame: Baseline and 36-38 weeks after baseline
Screening for mental illness
Postexperimental questionnaire
Time Frame: 36-38 weeks after baseline
Evaluation of the study
Secondary Outcomes
- Actigraphy measurement(Baseline)
- Sleep cartoon for children(Baseline and 36-38 weeks after baseline)
- Video of a sleeping sequence(Baseline)
- Demographic data(Baseline)
- Kiddie-Sads-Present and Lifetime Version (K-SADS PL)(Baseline)
- Self efficacy dealing with social situations (WIRKSOZ)(Baseline and 36-38 weeks after baseline)
- Group interviews(Baseline and 36-38 weeks after baseline)