E-health-supported Diagnostic and Intervention in Preterm Born Children and Their Families
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intervention Group (APP), Treatment as usual-Group (TAU).
- Who it may be relevant to
- Registry conditions: Preterm Birth. Basic parameters: 28 Weeks — 34 Weeks · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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 after estimated date of birth, and again after 2 months, as well as through focus groups with study participants.
Interventions
- 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.
Primary outcome measures
- Questionnaire on satisfaction, feasibility, needs (FB-NB) [Time frame: At month 4 (post-teatment, T1) and month 7 (follow-up, T2)]
- Parent Stress Inventory (EBI) [Time frame: At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).]
- Crying, Feeding and Sleeping Questionnaire (SFS) [Time frame: At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).]
Secondary outcome measures (12)
- Demographic data [Time frame: At baseline (before treatment, T0).]
- Brief Symptom Inventory (BSI) [Time frame: At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).]
- Brief Infant Sleep Questionnaire (BISQ) [Time frame: At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).]
- Edinburgh Postnatal Depression Scale (EPDS) [Time frame: At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).]
- Couple Conflict Questionnaire (PFB-K) [Time frame: At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).]
- Parent-Child Relationship Questionnaire (PBQ) [Time frame: At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).]
- Ulm Quality of Life Inventory for Parents (ULQIE) [Time frame: At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).]
- Ages & Stages Questionnaire®: Third Edition (ASQ-3) [Time frame: At month 4 (post-teatment, T1) and month 7 (follow-up, T2).]
- Focus groups [Time frame: At baseline (before treatment, T0), after month 7 (follow-up, T1).]
- App-questions [Time frame: Every 14 days over a period of 4 months (baseline, T0 - post-treatment, T1).]
- Questionnaire on health economics (HCU-Q) [Time frame: At month 4 (post-teatment, T1) and month 7 (follow-up, T2).]
- Self-efficacy questionnaire (SWE) [Time frame: At baseline (before treatment, T0), at month 4 (post-teatment, T1).]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Germany · 1 center
- University Hospital Tuebingen — Tübingen
Identifiers
NCT: NCT06939192 · 652/2023BO2