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

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: Active, not recruiting
• Conditions: Preterm Birth
• Intervention / Treatment: Other: Diagnostics and intervention recommendations

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: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Bayley Scales of Infant and Toddler Development	IQ testing	Baseline
Wechsler Intelligence Scale for Children (WISC-V)	IQ testing	Baseline
Children's Sleep Habit Questionnaire (CSHQ-DE 4-10)	Screening of sleeping behaviour	Baseline and 36-38 weeks after baseline
Sleep Self Report (SSR)	Screening of sleeping behaviour	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)	Baseline and 36-38 weeks after baseline
Child Behavior Checklist (CBCL)	Screening for mental illness	Baseline and 36-38 weeks after baseline
Youth Self Report (YSR)	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)	Screening for mental illness	Baseline and 36-38 weeks after baseline
KIDSCREEN-27 (The KIDSCREEN)	Health related quality of life	Baseline and 36-38 weeks after baseline
Parent's Stress Inventory (EBI)	Load as parents and relationship to the child	Baseline and 36-38 weeks after baseline
App-questions	Questions reflecting the questionnaires	Baseline and 36-38 weeks after baseline
Postexperimental questionnaire	Evaluation of the study	36-38 weeks after baseline

Secondary Outcome Measures

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

• Sponsor: University Hospital Tuebingen
• Investigators: 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

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: February 27, 2024
• First Submitted That Met QC Criteria: March 26, 2024
• First Posted (Actual): April 3, 2024

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 3, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: development; ehealth; interdisciplinary care; preterm born children; somatic and mental problems
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Premature Birth
• Other Study ID 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