Interdisciplinary E-health Based Follow-up of Preterm Born Children

Preterm Birth Clinical Trial

— NeoUp  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06345664
• Other study ID #: 548/2022BO1
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: University Hospital Tuebingen
• Contact: Annette Conzelmann, Prof. Dr.
• Phone: 004970712987513
• Email: annette.conzelmann[@]med.uni-tuebingen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Preterm Birth

Intervention

Other:
• Diagnostics and intervention recommendations
All families get the same diagnostics and receive individual treatment recommendations.

Locations

Country	Name	City	State
Germany	University Hospital Tuebingen	Tuebingen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bayley Scales of Infant and Toddler Development	IQ testing	Baseline
Primary	Wechsler Intelligence Scale for Children (WISC-V)	IQ testing	Baseline
Primary	Children's Sleep Habit Questionnaire (CSHQ-DE 4-10)	Screening of sleeping behaviour	Baseline and 36-38 weeks after baseline
Primary	Sleep Self Report (SSR)	Screening of sleeping behaviour	Baseline and 36-38 weeks after baseline
Primary	Somatics	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)	Baseline and 36-38 weeks after baseline
Primary	Child Behavior Checklist (CBCL)	Screening for mental illness	Baseline and 36-38 weeks after baseline
Primary	Youth Self Report (YSR)	Screening for mental illness	Baseline and 36-38 weeks after baseline
Primary	Diagnostic-system for mental illness for children and adolescents - III (DISYPS-III SCREEN FBB and SBB)	Screening for mental illness	Baseline and 36-38 weeks after baseline
Primary	KIDSCREEN-27 (The KIDSCREEN)	Health related quality of life	Baseline and 36-38 weeks after baseline
Primary	Parent's Stress Inventory (EBI)	Load as parents and relationship to the child	Baseline and 36-38 weeks after baseline
Primary	App-questions	Questions reflecting the questionnaires	Baseline and 36-38 weeks after baseline
Primary	Postexperimental questionnaire	Evaluation of the study	36-38 weeks after baseline
Secondary	Demographic data	age, gender, ethnicity, perinatal data from previous study participation	Baseline
Secondary	Actigraphy measurement	Device that the children are wearing at their wrists	Baseline
Secondary	Video of a sleeping sequence	The parents are taking a short video sequence of their sleeping child	Baseline
Secondary	Sleep cartoon for children	Cartoon sleep behavior	Baseline and 36-38 weeks after baseline
Secondary	Kiddie-Sads-Present and Lifetime Version (K-SADS PL)	Screening mental Illness	Baseline
Secondary	Self efficacy dealing with social situations (WIRKSOZ)	Self-efficacy measurement for social situations in children	Baseline and 36-38 weeks after baseline
Secondary	Group interviews	Group interviews with experts and families to get feedback about the study procedure and needs	Baseline and 36-38 weeks after baseline