Clinical trial NCT06345664: Interdisciplinary E-health Based Follow-up of Preterm Born Children
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Preterm Birth
Keywords: preterm born children
ehealth
development
somatic and mental problems
interdisciplinary care
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2024-04-03
Enrollment: 90
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_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

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

Primary outcomes:
measure: Bayley Scales of Infant and Toddler Development
timeFrame: Baseline
measure: Wechsler Intelligence Scale for Children (WISC-V)
timeFrame: Baseline
measure: Children's Sleep Habit Questionnaire (CSHQ-DE 4-10)
timeFrame: Baseline and 36-38 weeks after baseline
measure: Sleep Self Report (SSR)
timeFrame: Baseline and 36-38 weeks after baseline
measure: Somatics
timeFrame: Baseline and 36-38 weeks after baseline
measure: Child Behavior Checklist (CBCL)
timeFrame: Baseline and 36-38 weeks after baseline
measure: Youth Self Report (YSR)
timeFrame: Baseline and 36-38 weeks after baseline
measure: Diagnostic-system for mental illness for children and adolescents - III (DISYPS-III SCREEN FBB and SBB)
timeFrame: Baseline and 36-38 weeks after baseline
measure: KIDSCREEN-27 (The KIDSCREEN)
timeFrame: Baseline and 36-38 weeks after baseline
measure: Parent's Stress Inventory (EBI)
timeFrame: Baseline and 36-38 weeks after baseline
measure: App-questions
timeFrame: Baseline and 36-38 weeks after baseline
measure: Postexperimental questionnaire
timeFrame: 36-38 weeks after baseline
Secondary outcomes:
measure: Demographic data
timeFrame: Baseline
measure: Actigraphy measurement
timeFrame: Baseline
measure: Video of a sleeping sequence
timeFrame: Baseline
measure: Sleep cartoon for children
timeFrame: Baseline and 36-38 weeks after baseline
measure: Kiddie-Sads-Present and Lifetime Version (K-SADS PL)
timeFrame: Baseline
measure: Self efficacy dealing with social situations (WIRKSOZ)
timeFrame: Baseline and 36-38 weeks after baseline
measure: Group interviews
timeFrame: Baseline and 36-38 weeks after baseline
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: University Hospital Tuebingen
Study officials:
affiliation: University Hospital Tuebingen
name: Annette Conzelmann, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Tuebingen
name: Axel Franz, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Tuebingen
name: Mirja Quante, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Tuebingen
name: Ándrea Bevot, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Tuebingen
name: Tobias Renner, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: