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

NCT06939192 | Recruiting

• 1 other identifier: 652/2023BO2
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Birth

Keywords

Preterm birth; E-health; Risk factors; Protective factors; Prevention

Outcome Measures

Primary Outcomes (3)

• Questionnaire on satisfaction, feasibility, needs (FB-NB)

  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.

  At month 4 (post-teatment, T1) and month 7 (follow-up, T2)

• Parent Stress Inventory (EBI)

  The EBI measures the extent of parental stress and contains 48 items that are assigned to 12 subscales. Answering on a Likert scale.

  At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).

• Crying, Feeding and Sleeping Questionnaire (SFS)

  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.

  At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).

Secondary Outcomes (15)

• Demographic data

  At baseline (before treatment, T0).

• Brief Symptom Inventory (BSI)

  At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).

• Brief Infant Sleep Questionnaire (BISQ)

  At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).

• Edinburgh Postnatal Depression Scale (EPDS)

  At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).

• Couple Conflict Questionnaire (PFB-K)

  At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).

Study Arms (2)

Intervention Group (APP)

EXPERIMENTAL

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.

Other: Intervention Group (APP)

Treatment as usual Group (TAU)

ACTIVE COMPARATOR

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.

Other: Treatment as usual-Group (TAU)

Interventions

Intervention Group (APP) OTHER

Combination of app-based information and diagnostic screening for parents of premature babies.

Intervention Group (APP)

Treatment as usual-Group (TAU) OTHER

No intervention. Treatment in the form of usual aftercare service is possible.

Treatment as usual Group (TAU)

Eligibility Criteria

• Age: 28 Weeks - 34 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

University Hospital Tuebingen

Tübingen, Baden-Wurttemberg, 72076, Germany

RECRUITING

MeSH Terms

Conditions

Premature Birth

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Annette Conzelmann, Prof. Dr.

  Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University of Tübingen

  PRINCIPAL INVESTIGATOR

• Annika K Alt

  Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University of Tübingen

  STUDY CHAIR

• Tobias J Renner, Prof. Dr.

  Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University of Tübingen

  PRINCIPAL INVESTIGATOR

• Axel Franz, Prof. Dr.

  Neonatology, University of Tübingen

  STUDY CHAIR

• Mirja Quante, Dr.

  Neonatology, University of Tübingen

  STUDY CHAIR

• Michaela Minarski, Dr.

  Neonatology, University of Tübingen

  STUDY CHAIR

• Johanna Löchner, Prof. Dr.

  Clinical Psychology, FAU Erlangen

  STUDY CHAIR

Central Study Contacts

Annette Conzelmann, Prof.Dr.

CONTACT

00497071/29-87513; annette.conzelmann@med.uni-tuebingen.de

Annette Conzelmann, Prof. Dr.

CONTACT

00497071/29-87513; annette.conzelmann@med.uni-tuebingen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Annette Conzelmann

Model Details: RCT

Study Record Dates

• First Submitted: March 14, 2025
• First Posted: April 22, 2025
• Study Start: January 31, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Any time before and after completion of the study for 10 years.
• Access Criteria: Upon request.

Locations

DE (1)