NCT06939192

E-health-supported Diagnostic and Intervention in Preterm Born Children and Their Families

E-health-supported Recording of Psychological and Somatic Problems, Risk and Resilience Factors of Premature Born Infants and Their Families and Individualized, Interdisciplinary Stepped-care Approach

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University Hospital Tuebingen · Academic / Other
• Sex: All
• Age: 28 Weeks – 34 Weeks
• Healthy volunteers: Accepted

Summary

The app-based diagnostic and support approach with a focus on mental and somatic symptoms is intended to strengthen the resilience of premature born children and families and to identify risk and resilience factors.The overall objective of the study is to improve the post-inpatient care of families with premature born children. The procedure is evaluated by a two-arm design with an experimental group and a TAU group.

Detailed description

The project aims to conduct a longitudinal study of premature babies and their parents from the time of hospital discharge in order to identify predictive factors for their psychological and physical outcomes and to provide individualized interdisciplinary diagnostic and treatment. The project helps to identify risk and protective factors and also takes a closer look at the interplay between the mind and body. This care approach is supported by an app that records symptoms and needs and also allows contact with the study team. The app also provides psychoeducational materials. The study was developed in collaboration with affected families and experts from the aftercare team. The concept will be evaluated by comparing the treatment group with a TAU group and by conducting measurements after hospital discharge, after 4 months, and again after 7 months, as well as through focus groups with study participants.

Conditions

• Preterm Birth

Interventions

Type	Name	Description
OTHER	Intervention Group (APP)	Combination of app-based information and diagnostic screening for parents of premature babies.
OTHER	Treatment as usual-Group (TAU)	No intervention. Treatment in the form of usual aftercare service is possible.

Timeline

• Start date: 2024-01-31
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2025-04-22
• Last updated: 2025-04-22

Locations

1 site across 1 country: Germany