NCT06345664

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: University Hospital Tuebingen · Academic / Other
• Sex: All
• Age: 2 Years – 10 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
OTHER	Diagnostics and intervention recommendations	All families get the same diagnostics and receive individual treatment recommendations.

Timeline

• Start date: 2023-03-01
• Primary completion: 2025-05-01
• Completion: 2025-05-01
• First posted: 2024-04-03
• Last updated: 2025-03-19

Locations

1 site across 1 country: Germany