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

June 4, 2026 updated by: PD Dr. Annette Conzelmann, University Hospital Tuebingen

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Germany
    • Baden-Wurttemberg
      • Tübingen, Baden-Wurttemberg, Germany, 72076

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Questionnaire on satisfaction, feasibility, needs (FB-NB)
Time Frame: 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.
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).
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)
Time Frame: 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.
At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Demographic data
Time Frame: At baseline (before treatment, T0).
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)
Time Frame: 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.
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).
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)
Time Frame: 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.
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).
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)
Time Frame: 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.
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).
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)
Time Frame: 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.
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).
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
Time Frame: 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
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).
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)
Time Frame: At baseline (before treatment, T0), at month 4 (post-teatment, T1).
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).
On-site clinical examination: Assessment of height in cm
Time Frame: At baseline (before treatment, T0), at month 4 (post-teatment, T1).
Assessment of height in cm assessed by a neonatologist.
At baseline (before treatment, T0), at month 4 (post-teatment, T1).
On-site clinical examination: Assessment of weight in g
Time Frame: At baseline (before treatment, T0), at month 4 (post-teatment, T1).
Assessment of weight in g by neonatgologist
At baseline (before treatment, T0), at month 4 (post-teatment, T1).
On-site clinical examination: Assessment of self-reported illnesses of the child
Time Frame: At baseline (before treatment, T0), at month 4 (post-teatment, T1).
Assessment of partents' reports of illnesses of the child. Open answer format, no scale.
At baseline (before treatment, T0), at month 4 (post-teatment, T1).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital Tuebingen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 31, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 14, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 22, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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