Preterm BirthNeoUpNCT06345664
Interdisciplinary E-health Based Follow-up of Preterm Born Children
A study testing Diagnostics and intervention recommendations in people with Preterm Birth, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth
- What is being tested?
- Diagnostics and intervention recommendations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteGermany
- Study dates
- 1 Mar 2023to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
Who cannot join
- lack of access to a mobile phone/tablet including internet access
- insufficient knowledge of the German language of both parents
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Preterm Birth
- Being tested
- Diagnostics and intervention recommendations
- Keywords
- preterm born children, ehealth, development, somatic and mental problems, interdisciplinary care
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostics and intervention recommendationsOther
Also called Differentiated diagnostics and treatment recommendations
All families get the same diagnostics and receive individual treatment recommendations.
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic assessments and intervention | Other | All families get a diagnostics and intervention recommendations. Receives: Other: Diagnostics and intervention recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bayley Scales of Infant and Toddler Development
IQ testing
Measured: Baseline
Wechsler Intelligence Scale for Children (WISC-V)
IQ testing
Measured: Baseline
Children's Sleep Habit Questionnaire (CSHQ-DE 4-10)
Screening of sleeping behaviour
Measured: Baseline and 36-38 weeks after baseline
Sleep Self Report (SSR)
Screening of sleeping behaviour
Measured: Baseline and 36-38 weeks after baseline
Somatics
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)
Measured: Baseline and 36-38 weeks after baseline
Child Behavior Checklist (CBCL)
Screening for mental illness
Measured: Baseline and 36-38 weeks after baseline
Youth Self Report (YSR)
Screening for mental illness
Measured: Baseline and 36-38 weeks after baseline
Diagnostic-system for mental illness for children and adolescents - III (DISYPS-III SCREEN FBB and SBB)
Screening for mental illness
Measured: Baseline and 36-38 weeks after baseline
KIDSCREEN-27 (The KIDSCREEN)
Health related quality of life
Measured: Baseline and 36-38 weeks after baseline
Parent's Stress Inventory (EBI)
Load as parents and relationship to the child
Measured: Baseline and 36-38 weeks after baseline
App-questions
Questions reflecting the questionnaires
Measured: Baseline and 36-38 weeks after baseline
Postexperimental questionnaire
Evaluation of the study
Measured: 36-38 weeks after baseline
Secondary outcomes (7)
Demographic data
age, gender, ethnicity, perinatal data from previous study participation
Measured: Baseline
Actigraphy measurement
Device that the children are wearing at their wrists
Measured: Baseline
Video of a sleeping sequence
The parents are taking a short video sequence of their sleeping child
Measured: Baseline
Sleep cartoon for children
Cartoon sleep behavior
Measured: Baseline and 36-38 weeks after baseline
Kiddie-Sads-Present and Lifetime Version (K-SADS PL)
Screening mental Illness
Measured: Baseline
Self efficacy dealing with social situations (WIRKSOZ)
Self-efficacy measurement for social situations in children
Measured: Baseline and 36-38 weeks after baseline
Group interviews
Group interviews with experts and families to get feedback about the study procedure and needs
Measured: Baseline and 36-38 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start1 Mar 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PD Dr. Annette Conzelmann, University Hospital Tuebingen
- Investigators
- Annette Conzelmann, Prof. Dr., Principal investigator, University Hospital TuebingenAxel Franz, Prof. Dr., Principal investigator, University Hospital TuebingenMirja Quante, Dr., Principal investigator, University Hospital TuebingenÁndrea Bevot, Dr., Principal investigator, University Hospital TuebingenTobias Renner, Prof. Dr., Principal investigator, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06345664
- Sponsor's protocol ID
- 548/2022BO1
- Acronym
- NeoUp
- Status last verified
- Jun 2026
- First submitted
- 27 Feb 2024
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We share study material and statistical outputs.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06345664
- Acronym / sponsor ID
- NeoUp / 548/2022BO1
- Conditions
- Preterm Birth
- Keywords
- preterm born children, ehealth, development, somatic and mental problems, interdisciplinary care
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 3 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic assessments and intervention | Other | Other: Diagnostics and intervention recommendationsAll families get a diagnostics and intervention recommendations. |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (2 listed)
- lack of access to a mobile phone/tablet including internet access
- insufficient knowledge of the German language of both parents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostics and intervention recommendationsAlso: Differentiated diagnostics and treatment recommendationsAll families get the same diagnostics and receive individual treatment recommendations. | Other | Diagnostic assessments and intervention |
Primary outcome
Bayley Scales of Infant and Toddler Development
Time frame: Baseline
IQ testing
Wechsler Intelligence Scale for Children (WISC-V)
Time frame: Baseline
IQ testing
Children's Sleep Habit Questionnaire (CSHQ-DE 4-10)
Time frame: Baseline and 36-38 weeks after baseline
Screening of sleeping behaviour
Sleep Self Report (SSR)
Time frame: Baseline and 36-38 weeks after baseline
Screening of sleeping behaviour
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)
Child Behavior Checklist (CBCL)
Time frame: Baseline and 36-38 weeks after baseline
Screening for mental illness
Youth Self Report (YSR)
Time frame: Baseline and 36-38 weeks after baseline
Screening for mental illness
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
KIDSCREEN-27 (The KIDSCREEN)
Time frame: Baseline and 36-38 weeks after baseline
Health related quality of life
Parent's Stress Inventory (EBI)
Time frame: Baseline and 36-38 weeks after baseline
Load as parents and relationship to the child
App-questions
Time frame: Baseline and 36-38 weeks after baseline
Questions reflecting the questionnaires
Postexperimental questionnaire
Time frame: 36-38 weeks after baseline
Evaluation of the study
7 secondary outcomes
Demographic data
Time frame: Baseline
Actigraphy measurement
Time frame: Baseline
Video of a sleeping sequence
Time frame: Baseline
Sleep cartoon for children
Time frame: Baseline and 36-38 weeks after baseline
Kiddie-Sads-Present and Lifetime Version (K-SADS PL)
Time frame: Baseline
Self efficacy dealing with social situations (WIRKSOZ)
Time frame: Baseline and 36-38 weeks after baseline
Group interviews
Time frame: Baseline and 36-38 weeks after baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: Yes. We share study material and statistical outputs.
Related trials for Preterm Birth
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annette Conzelmann, Prof. Dr. principal investigator
University Hospital Tuebingen
Axel Franz, Prof. Dr. principal investigator
University Hospital Tuebingen
Mirja Quante, Dr. principal investigator
University Hospital Tuebingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnostics and intervention recommendations in people with Preterm Birth, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bayley Scales of Infant and Toddler Development (time frame: Baseline). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.