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NCT Number: NCT06345664

Interdisciplinary E-health Based Follow-up of Preterm Born Children

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

2 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Tuebingen

Tübingen, 72076, Germany

About this study

  • 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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diagnostics and intervention recommendations

Other

All families get the same diagnostics and receive individual treatment recommendations.

Other names: Differentiated diagnostics and treatment recommendations

Primary outcomes

  1. Bayley Scales of Infant and Toddler Development

    Time frame: Baseline

    IQ testing

  2. Wechsler Intelligence Scale for Children (WISC-V)

    Time frame: Baseline

    IQ testing

  3. Children's Sleep Habit Questionnaire (CSHQ-DE 4-10)

    Time frame: Baseline and 36-38 weeks after baseline

    Screening of sleeping behaviour

  4. Sleep Self Report (SSR)

    Time frame: Baseline and 36-38 weeks after baseline

    Screening of sleeping behaviour

  5. 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)

  6. Child Behavior Checklist (CBCL)

    Time frame: Baseline and 36-38 weeks after baseline

    Screening for mental illness

  7. Youth Self Report (YSR)

    Time frame: Baseline and 36-38 weeks after baseline

    Screening for mental illness

  8. 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

  9. KIDSCREEN-27 (The KIDSCREEN)

    Time frame: Baseline and 36-38 weeks after baseline

    Health related quality of life

  10. Parent's Stress Inventory (EBI)

    Time frame: Baseline and 36-38 weeks after baseline

    Load as parents and relationship to the child

  11. App-questions

    Time frame: Baseline and 36-38 weeks after baseline

    Questions reflecting the questionnaires

  12. Postexperimental questionnaire

    Time frame: 36-38 weeks after baseline

    Evaluation of the study

Secondary outcomes

  1. Demographic data

    Time frame: Baseline

    age, gender, ethnicity, perinatal data from previous study participation

  2. Actigraphy measurement

    Time frame: Baseline

    Device that the children are wearing at their wrists

  3. Video of a sleeping sequence

    Time frame: Baseline

    The parents are taking a short video sequence of their sleeping child

  4. Sleep cartoon for children

    Time frame: Baseline and 36-38 weeks after baseline

    Cartoon sleep behavior

  5. Kiddie-Sads-Present and Lifetime Version (K-SADS PL)

    Time frame: Baseline

    Screening mental Illness

  6. Self efficacy dealing with social situations (WIRKSOZ)

    Time frame: Baseline and 36-38 weeks after baseline

    Self-efficacy measurement for social situations in children

  7. 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

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Official study 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

Acronym: NeoUp

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 3, 2024
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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