E-health-supported Diagnostic and Intervention in Preterm Born Children and Their Families (NeoUp2)

University Hospital Tuebingen

Status: Enrolling

Conditions: Preterm Birth

Treatments: Other: Treatment as usual-Group (TAU); Other: Intervention Group (APP)

Study type: Interventional

Funder types: Other

Identifiers

NCT06939192

652/2023BO2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 28 to 34 weeks old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Premature babies born at the UKT,
• Gestational age 28-34 weeks,
• Mother: age ≥ 18 years,
• agreement to participate in this study and signing of a consent form,
• sufficient knowledge of German,
• internet access

Exclusion criteria

• Premature babies < 28th or >34th week of pregnancy,
• at least one of the children has serious diseases of the nervous system or obvious symptoms of a nervous disease,
• at least one of the children has serious congenital diseases or suffers from malformations,
• Mother: Lack of access to a smartphone/tablet,
• no internet access,
• insufficient knowledge of German

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Intervention Group (APP)

Experimental group

Description:

The participants in the intervention group will be equipped with an app after inclusion in the study. The app contains specific information for parents with premature babies, a contact form for experts and questions about the child's development every 14 days.

Treatment:

Other: Intervention Group (APP)

Treatment as usual Group (TAU)

Active Comparator group

Description:

Participants in the treatment as usual group do not receive an app after inclusion in the study. They can contact their pediatrician if they have any questions.

Treatment:

Other: Treatment as usual-Group (TAU)