Interdisciplinary E-health Based Follow-up of Preterm Born Children (NeoUp)

June 3, 2026 updated by: PD Dr. Annette Conzelmann, University Hospital Tuebingen

Interdisciplinary, E-health Based, Multimodal Follow-up of Somatic, Sleep-related and Psychological Symptoms of Very Immature Preterm Born Babies in Different Age Groups for the Further Development of Previous Care Structures

The aim of the study is to assess mental and somatic symptoms of preterm born children at the ages of 2, 5 and 10 by a multidisciplinary team and to evaluate an app that screens for these symptoms. Furthermore, there will be an evaluation of an intervention by our multidisciplinary team that provides recommendations for further treatment and diagnostic procedures of the children.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not 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

  • At first, there will be focus groups with experts and affected families to finalize and optimize the study procedure. After that, 90 children will be recruited (ages 2, 5 and 10)
  • T0: App-questions for the children at the ages of 5 and 10 and the parents of all children to mental, somatic and sleep problems of the children and well-being of the parents, sleep tracking and recording of a sleep sequence of the children; differentiated examinations and questionnaires to mental and somatic problems of the children by interdisciplinary study team
  • Interdisciplinary study team meeting to generate recommendations for the families
  • Interdisciplinary study team recommendations for the families
  • T1: Comparable to T0 but only measurements that were assessed with questionnaires/at home plus post-experimental questionnaire
  • Focus groups with participating families and the study team experts for evaluation of the study procedure and intervention

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.
90

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 Locations

  • Germany
      • Tübingen, Germany, 72076
        • University Hospital Tuebingen

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:

  • female and male preterm born children (<32 week of pregnancy) that are treated at the clinic in Tübingen and their parents
  • Existence of systematical neonatal data and consent of the care person to use this data
  • Existence of the data of the 2 year regular follow-up (for the 5 and 10 year olds)

Exclusion Criteria:

  • lack of access to a mobile phone/tablet including internet access
  • insufficient knowledge of the German language of both parents

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: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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.
Other: Diagnostic assessments and intervention
All families get a diagnostics and intervention recommendations.
Other: Diagnostics and intervention recommendations
All families get the same diagnostics and receive individual treatment recommendations.
Other Names:
  • Differentiated diagnostics and treatment recommendations

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
Bayley Scales of Infant and Toddler Development
Time Frame: Baseline
IQ testing
Baseline
Wechsler Intelligence Scale for Children (WISC-V)
Time Frame: Baseline
IQ testing
Baseline
Children's Sleep Habit Questionnaire (CSHQ-DE 4-10)
Time Frame: Baseline and 36-38 weeks after baseline
Screening of sleeping behaviour
Baseline and 36-38 weeks after baseline
Sleep Self Report (SSR)
Time Frame: Baseline and 36-38 weeks after baseline
Screening of sleeping behaviour
Baseline and 36-38 weeks after baseline
Somatics
Time Frame: Baseline and 36-38 weeks after baseline
Questions to somatic symptoms (diagnoses, inpatient stays, medication, early support) physical therapy, hearing impairment or visual disturbance, pulmonary symptoms, seizure disorders, health related quality of life, body weight, size)
Baseline and 36-38 weeks after baseline
Child Behavior Checklist (CBCL)
Time Frame: Baseline and 36-38 weeks after baseline
Screening for mental illness
Baseline and 36-38 weeks after baseline
Youth Self Report (YSR)
Time Frame: Baseline and 36-38 weeks after baseline
Screening for mental illness
Baseline and 36-38 weeks after baseline
Diagnostic-system for mental illness for children and adolescents - III (DISYPS-III SCREEN FBB and SBB)
Time Frame: Baseline and 36-38 weeks after baseline
Screening for mental illness
Baseline and 36-38 weeks after baseline
KIDSCREEN-27 (The KIDSCREEN)
Time Frame: Baseline and 36-38 weeks after baseline
Health related quality of life
Baseline and 36-38 weeks after baseline
Parent's Stress Inventory (EBI)
Time Frame: Baseline and 36-38 weeks after baseline
Load as parents and relationship to the child
Baseline and 36-38 weeks after baseline
App-questions
Time Frame: Baseline and 36-38 weeks after baseline
Questions reflecting the questionnaires
Baseline and 36-38 weeks after baseline
Postexperimental questionnaire
Time Frame: 36-38 weeks after baseline
Evaluation of the study
36-38 weeks after baseline

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: Baseline
age, gender, ethnicity, perinatal data from previous study participation
Baseline
Actigraphy measurement
Time Frame: Baseline
Device that the children are wearing at their wrists
Baseline
Video of a sleeping sequence
Time Frame: Baseline
The parents are taking a short video sequence of their sleeping child
Baseline
Sleep cartoon for children
Time Frame: Baseline and 36-38 weeks after baseline
Cartoon sleep behavior
Baseline and 36-38 weeks after baseline
Kiddie-Sads-Present and Lifetime Version (K-SADS PL)
Time Frame: Baseline
Screening mental Illness
Baseline
Self efficacy dealing with social situations (WIRKSOZ)
Time Frame: Baseline and 36-38 weeks after baseline
Self-efficacy measurement for social situations in children
Baseline and 36-38 weeks after baseline
Group interviews
Time Frame: Baseline and 36-38 weeks after baseline
Group interviews with experts and families to get feedback about the study procedure and needs
Baseline and 36-38 weeks after baseline

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., University Hospital Tuebingen
  • Principal Investigator: Axel Franz, Prof. Dr., University Hospital Tuebingen
  • Principal Investigator: Mirja Quante, Dr., University Hospital Tuebingen
  • Principal Investigator: Ándrea Bevot, Dr., University Hospital Tuebingen
  • Principal Investigator: Tobias Renner, Prof. Dr., University Hospital Tuebingen

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.
March 1, 2023

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 1, 2026

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 1, 2026

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).
February 27, 2024

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.
March 26, 2024

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 3, 2024

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 4, 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 3, 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.
  • 548/2022BO1

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

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings