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

NCT06345664 | Active Not Recruiting

• 1 other identifier: 548/2022BO1
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Birth

Keywords

preterm born children; ehealth; development; somatic and mental problems; interdisciplinary care

Outcome Measures

Primary Outcomes (12)

• Bayley Scales of Infant and Toddler Development

  IQ testing

  Baseline

• Wechsler Intelligence Scale for Children (WISC-V)

  IQ testing

  Baseline

• Children's Sleep Habit Questionnaire (CSHQ-DE 4-10)

  Screening of sleeping behaviour

  Baseline and 36-38 weeks after baseline

• Sleep Self Report (SSR)

  Screening of sleeping behaviour

  Baseline and 36-38 weeks after baseline

• 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

• Child Behavior Checklist (CBCL)

  Screening for mental illness

  Baseline and 36-38 weeks after baseline

• Youth Self Report (YSR)

  Screening for mental illness

  Baseline and 36-38 weeks after baseline

• 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

• KIDSCREEN-27 (The KIDSCREEN)

  Health related quality of life

  Baseline and 36-38 weeks after baseline

• Parent's Stress Inventory (EBI)

  Load as parents and relationship to the child

  Baseline and 36-38 weeks after baseline

• App-questions

  Questions reflecting the questionnaires

  Baseline and 36-38 weeks after baseline

• Postexperimental questionnaire

  Evaluation of the study

  36-38 weeks after baseline

Secondary Outcomes (7)

• Demographic data

  Baseline

• Actigraphy measurement

  Baseline

• Video of a sleeping sequence

  Baseline

• Sleep cartoon for children

  Baseline and 36-38 weeks after baseline

• Kiddie-Sads-Present and Lifetime Version (K-SADS PL)

  Baseline

Study Arms (1)

Diagnostic assessments and intervention

OTHER

All families get a diagnostics and intervention recommendations.

Other: Diagnostics and intervention recommendations

Interventions

Diagnostics and intervention recommendations OTHER

All families get the same diagnostics and receive individual treatment recommendations.

Also known as: Differentiated diagnostics and treatment recommendations

Diagnostic assessments and intervention

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• lack of access to a mobile phone/tablet including internet access
• insufficient knowledge of the German language of both parents

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

University Hospital Tuebingen

Tübingen, 72076, Germany

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Annette Conzelmann, Prof. Dr.

  University Hospital Tuebingen

  PRINCIPAL INVESTIGATOR

• Axel Franz, Prof. Dr.

  University Hospital Tuebingen

  PRINCIPAL INVESTIGATOR

• Mirja Quante, Dr.

  University Hospital Tuebingen

  PRINCIPAL INVESTIGATOR

• Ándrea Bevot, Dr.

  University Hospital Tuebingen

  PRINCIPAL INVESTIGATOR

• Tobias Renner, Prof. Dr.

  University Hospital Tuebingen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: April 3, 2024
• Study Start: March 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 4, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Any time before and after completion of the study for 10 years.
• Access Criteria: Upon request.

Locations

DE (1)