RecruitingNot Applicable

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

Germany120 participantsStarted 2024-01-31

Plain-language 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 children. The procedure is evaluated by a two-arm design with an experimental group and a TAU group.

Who can participate

Age range

28 Weeks – 34 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Questionnaire on satisfaction, feasibility, needs (FB-NB)

Timeframe: At month 4 (post-teatment, T1) and month 7 (follow-up, T2)

Parent Stress Inventory (EBI)

Timeframe: At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).

Crying, Feeding and Sleeping Questionnaire (SFS)

Timeframe: At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).

Trial details

NCT IDNCT06939192

SponsorUniversity Hospital Tuebingen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-31

Contact for this trial

Annette Conzelmann, Prof.Dr.

00497071/29-87513 annette.conzelmann@med.uni-tuebingen.de

View on ClinicalTrials.gov More Preterm Birth trials

Plain-language summary

Who can participate

Age range

28 Weeks – 34 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Questionnaire on satisfaction, feasibility, needs (FB-NB)

Timeframe: At month 4 (post-teatment, T1) and month 7 (follow-up, T2)

Parent Stress Inventory (EBI)

Timeframe: At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).

Crying, Feeding and Sleeping Questionnaire (SFS)

Timeframe: At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).