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

NCT ID: NCT06345664

Last Updated: 2025-03-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2025-05-31

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

Conditions

Preterm Birth

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Diagnostic assessments and intervention

All families get a diagnostics and intervention recommendations.

Group Type: OTHER

Diagnostics and intervention recommendations

Intervention Type: OTHER

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

Interventions

Diagnostics and intervention recommendations

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

Intervention Type: OTHER

Other Intervention Names

Differentiated diagnostics and treatment recommendations

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital Tuebingen

OTHER

Sponsor Role: lead

Responsible Party

PD Dr. Annette Conzelmann

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Annette Conzelmann, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Tuebingen

Axel Franz, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Tuebingen

Mirja Quante, Dr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Tuebingen

Ándrea Bevot, Dr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Tuebingen

Tobias Renner, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Tuebingen

Locations

University Hospital Tuebingen

Tübingen, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Annette Conzelmann, Prof. Dr.

Role: CONTACT

annette.conzelmann@med.uni-tuebingen.de

004970712987513

Facility Contacts

Annette Conzelmann, Prof. Dr.

Role: primary

Other Identifiers

548/2022BO1

Identifier Type: -

Identifier Source: org_study_id