Preterm BirthNeoUp2NCT06939192
E-health-supported Diagnostic and Intervention in Preterm Born Children and Their Families
A study testing Intervention Group (APP) and Treatment as usual-Group (TAU) in people with Preterm Birth, run by University Hospital Tuebingen at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 28 to 34 weeksHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth
- What is being tested?
- Intervention Group (APP) and Treatment as usual-Group (TAU)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- 31 Jan 2024to 31 Dec 2027
- 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 28 to 34 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Tuebingen
Tübingen, Baden-Wurttemberg, 72076
Annette Conzelmann, Prof. Dr., 00497071/29-87513, annette.conzelmann@med.uni-tuebingen.de
About this study
Official title: 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.
Read the 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.
- Conditions
- Preterm Birth
- Being tested
- Intervention Group (APP), Treatment as usual-Group (TAU)
- Keywords
- Preterm birth, E-health, Risk factors, Protective factors, Prevention
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention Group (APP)Other
Combination of app-based information and diagnostic screening for parents of premature babies.
Treatment as usual-Group (TAU)Other
No intervention. Treatment in the form of usual aftercare service is possible.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Treatment as usual-Group (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).
Secondary outcomes (15)
Demographic data
The questionnaire includes, among other things, the age, gender, ethnicity and socio-demographic data of the test subjects.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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).
Measured: At baseline (before treatment, T0), at month 4 (post-teatment, T1).
On-site clinical examination: Assessment of height in cm
Assessment of height in cm assessed by a neonatologist.
Measured: At baseline (before treatment, T0), at month 4 (post-teatment, T1).
On-site clinical examination: Assessment of weight in g
Assessment of weight in g by neonatgologist
Measured: At baseline (before treatment, T0), at month 4 (post-teatment, T1).
On-site clinical examination: Assessment of self-reported illnesses of the child
Assessment of partents' reports of illnesses of the child. Open answer format, no scale.
Measured: At baseline (before treatment, T0), at month 4 (post-teatment, T1).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start31 Jan 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 120 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, Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University of TübingenAnnika K Alt, Study chair, Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University of TübingenTobias J Renner, Prof. Dr., Principal investigator, Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University of TübingenAxel Franz, Prof. Dr., Study chair, Neonatology, University of TübingenMirja Quante, Dr., Study chair, Neonatology, University of TübingenMichaela Minarski, Dr., Study chair, Neonatology, University of TübingenJohanna Löchner, Prof. Dr., Study chair, Clinical Psychology, FAU Erlangen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06939192
- Sponsor's protocol ID
- 652/2023BO2
- Acronym
- NeoUp2
- Status last verified
- Jun 2026
- First submitted
- 14 Mar 2025
- Last updated
- 9 Jun 2026
- Results posted
- 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 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06939192
- Acronym / sponsor ID
- NeoUp2 / 652/2023BO2
- Conditions
- Preterm Birth
- Keywords
- Preterm birth, E-health, Risk factors, Protective factors, Prevention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 31 Jan 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 22 Apr 2025 (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 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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- RCT
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (APP) | Experimental | Other: 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. |
| Treatment as usual Group (TAU) | Active comparator | Other: 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. |
Who may qualify
- Ages
- 28 to 34 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (6 listed)
- 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,
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 |
|---|---|---|
| Intervention Group (APP)Combination of app-based information and diagnostic screening for parents of premature babies. | Other | Intervention Group (APP) |
| Treatment as usual-Group (TAU)No intervention. Treatment in the form of usual aftercare service is possible. | Other | Treatment as usual Group (TAU) |
Primary outcome
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.
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.
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.
15 secondary outcomes
Demographic data
Time frame: 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).
Brief Infant Sleep Questionnaire (BISQ)
Time frame: 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).
Couple Conflict Questionnaire (PFB-K)
Time frame: 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).
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).
Ages & Stages Questionnaire®: Third Edition (ASQ-3)
Time frame: 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).
App-questions
Time frame: 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).
Self-efficacy questionnaire (SWE)
Time frame: 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).
On-site clinical examination: Assessment of weight in g
Time frame: 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).
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 9 Jun 2026.
- Individual participant dataSharing planned: Yes. We share study material and statistical outputs.
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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.
Annette Conzelmann, Prof. Dr. principal investigator
Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University of Tübingen
Annika K Alt study chair
Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University of Tübingen
Tobias J Renner, Prof. Dr. principal investigator
Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University of Tübingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group (APP) and Treatment as usual-Group (TAU) 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 6 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 9 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?
Contact Annette Conzelmann, Prof.Dr. (00497071/29-87513, annette.conzelmann@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnaire on satisfaction, feasibility, needs (FB-NB) (time frame: At month 4 (post-teatment, T1) and month 7 (follow-up, T2)). The study lists 3 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 9 Jun 2026.