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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Preterm Birth
• Intervention / Treatment: Other: Intervention Group (APP); Other: Treatment as usual-Group (TAU)

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Annette Conzelmann, Prof.Dr.; Phone Number: 00497071/29-87513; Email: annette.conzelmann@med.uni-tuebingen.de
• Study Contact Backup: Name: Annette Conzelmann, Prof. Dr.; Phone Number: 00497071/29-87513; Email: annette.conzelmann@med.uni-tuebingen.de

Study Locations

• Germany
  • Baden-Württemberg
    • Tuebingen, Baden-Württemberg, Germany, 72076
      • Recruiting
      • University Hospital Tuebingen
      • Contact: Annette Conzelmann, Prof. Dr.; Phone Number: 00497071/29-87513; Email: annette.conzelmann@med.uni-tuebingen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group (APP); 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); Combination of app-based information and diagnostic screening for parents of premature babies.
Active Comparator: Treatment as usual Group (TAU); 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); No intervention. Treatment in the form of usual aftercare service is possible.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic data	The questionnaire includes, among other things, the age, gender, ethnicity and socio-demographic data of the test subjects.	At baseline (before treatment, T0).
Brief Symptom Inventory (BSI)	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.	At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).
Brief Infant Sleep Questionnaire (BISQ)	The BISQ is a short and simple questionnaire about the child's sleep duration, nocturnal awakenings and methods of falling asleep.	At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).
Edinburgh Postnatal Depression Scale (EPDS)	The EPDS measures depression in the last 7 days with 10 items.	At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).
Couple Conflict Questionnaire (PFB-K)	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.	At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).
Parent-Child Relationship Questionnaire (PBQ)	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.	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)	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).	At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).
Ages & Stages Questionnaire®: Third Edition (ASQ-3)	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.	At month 4 (post-teatment, T1) and month 7 (follow-up, T2).
Focus groups	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.	At baseline (before treatment, T0), after month 7 (follow-up, T1).
App-questions	Questions about the child's and parents' state of health, well-being and perception of stress	Every 14 days over a period of 4 months (baseline, T0 - post-treatment, T1).
Questionnaire on health economics (HCU-Q)	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.	At month 4 (post-teatment, T1) and month 7 (follow-up, T2).
Self-efficacy questionnaire (SWE)	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).	At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).

Collaborators and Investigators

• Sponsor: University Hospital Tuebingen
• Investigators: Principal Investigator: Annette Conzelmann, Prof. Dr., Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University of Tübingen; Study Chair: Annika K Alt, Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University of Tübingen; Principal Investigator: Tobias J Renner, Prof. Dr., Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University of Tübingen; Study Chair: 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 record dates

Study Major Dates

• Study Start (Actual): January 31, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: March 14, 2025
• First Submitted That Met QC Criteria: April 14, 2025
• First Posted (Actual): April 22, 2025

Study Record Updates

• Last Update Posted (Actual): April 22, 2025
• Last Update Submitted That Met QC Criteria: April 14, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Prevention; Risk factors; E-health; Preterm birth; Protective factors
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Premature Birth
• Other Study ID Numbers: 652/2023BO2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We share study material and statistical outputs.
• IPD Sharing Time Frame: Any time before and after completion of the study for 10 years.
• IPD Sharing Access Criteria: Upon request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No