Interdisciplinary E-health Based Follow-up of Preterm Born Children (NeoUp)

University Hospital Tuebingen

Status: Enrolling

Conditions: Preterm Birth

Treatments: Other: Diagnostics and intervention recommendations

Study type: Interventional

Funder types: Other

Identifiers

NCT06345664

548/2022BO1

Details and patient eligibility

About

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.

Full 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

Enrollment: 90 estimated patients

Sex: All

Ages: 2 to 10 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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90 participants in 1 patient group

Diagnostic assessments and intervention

Other group

Description:

All families get a diagnostics and intervention recommendations.

Treatment:

Other: Diagnostics and intervention recommendations