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

Not Applicable

Recruiting

• Conditions: Preterm Birth

• Registration Number: NCT06939192
• Lead Sponsor: University Hospital Tuebingen

Brief 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.

Study Timeline

• Study Start: 2024-01-31
• Study First Submitted: 2025-03-14
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-14
• Last Update Submitted: 2025-04-14
• Study First Posted: 2025-04-22
• Last Update Posted: 2025-04-22
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Questionnaire on satisfaction, feasibility, needs (FB-NB)	At month 4 (post-teatment, T1) and month 7 (follow-up, T2)	After completion of the main study phase, the self-constructed questionnaire assesses satisfaction with the study concept and evaluates the feasibility of the study approach. Patients are asked to indicate their satisfaction using a Likert scale and can also note down any additional or modification requests in free text fields.
Crying, Feeding and Sleeping Questionnaire (SFS)	At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).	The questionnaire on regulatory disorders in childhood uses 54 questions to assess early childhood regulatory disorders in relation to crying, eating or sleeping. The response format is generally a 4-point scale from not at all to very much.
Parent Stress Inventory (EBI)	At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).	The EBI measures the extent of parental stress and contains 48 items that are assigned to 12 subscales. Answering on a Likert scale.

Secondary Outcome Measures

Name	Time	Method
Demographic data	At baseline (before treatment, T0).	The questionnaire includes, among other things, the age, gender, ethnicity and socio-demographic data of the test subjects.
Ages & Stages Questionnaire®: Third Edition (ASQ-3)	At month 4 (post-teatment, T1) and month 7 (follow-up, T2).	The questionnaire is a developmental screening tool that measures developmental progress in children aged 1 month to 5 ½ years. It comprises a total of 30 questions, 6 for each developmental area on child communication, fine and gross motor skills, problem solving and social behavior.
Focus groups	At baseline (before treatment, T0), after month 7 (follow-up, T1).	Conducting several focus groups with parents and professionals on the needs of post-inpatient care for parents with a premature baby. Survey of needs and feedback from the app group.
Brief Symptom Inventory (BSI)	At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).	The questionnaire is a short form of the SCL-90-R and measures the subjectively perceived impairment of a person through physical and psychological symptoms on nine scales (somatization, compulsiveness, insecurity in social contact, depressiveness, anxiety, aggressiveness / hostility, phobic anxiety, paranoid thinking, psychoticism) with 53 items, within a period of 7 days. Answering the questions on a Likert scale from 0 to 4.
Parent-Child Relationship Questionnaire (PBQ)	At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).	The PBQ is an instrument for assessing the quality of the postpartum relationship between mother and child. The questionnaire comprises 25 items and is answered on a Likert scale from 1 to 6.
Ulm Quality of Life Inventory for Parents (ULQIE)	At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).	The questionnaire comprises a total of 29 items on the well-being and quality of life of the parent, covering a period of one week, answered on a five-point Likert scale from 0 (never) to 5 (always).
Brief Infant Sleep Questionnaire (BISQ)	At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).	The BISQ is a short and simple questionnaire about the child's sleep duration, nocturnal awakenings and methods of falling asleep.
Edinburgh Postnatal Depression Scale (EPDS)	At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).	The EPDS measures depression in the last 7 days with 10 items.
Couple Conflict Questionnaire (PFB-K)	At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).	The partnership questionnaire measures the quality of the partnership with only 9 items in 3 subcategories (argumentative behavior, tenderness, communication), answered on a Likert scale.
Questionnaire on health economics (HCU-Q)	At month 4 (post-teatment, T1) and month 7 (follow-up, T2).	The translated questionnaire for measuring the use of healthcare services was developed based on the Health Care Utilization Questionnaire. Due to the young age of the children, some items were replaced. The questionnaire is intended to assess the families' respective use and utilization of medical and non-medical health care services.
App-questions	Every 14 days over a period of 4 months (baseline, T0 - post-treatment, T1).	Questions about the child's and parents' state of health, well-being and perception of stress
Self-efficacy questionnaire (SWE)	At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).	10 items on dealing with difficult situations and one's own perceived self-efficacy, answered on a scale from 1 (not true) to 4 (true).

Trial Locations

Locations (1)

University Hospital Tuebingen; 🇩🇪 Tuebingen, Baden-Württemberg, Germany