Ignite Creation Date:
2025-12-24 @ 3:21 PM
Ignite Modification Date:
2025-12-26 @ 7:31 PM
Study NCT ID:
NCT06939192
Status:
RECRUITING
Last Update Posted:
2025-04-22
First Post:
2025-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
E-health-supported Diagnostic and Intervention in Preterm Born Children and Their Families
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'RCT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-14', 'studyFirstSubmitDate': '2025-03-14', 'studyFirstSubmitQcDate': '2025-04-14', 'lastUpdatePostDateStruct': {'date': '2025-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Questionnaire on satisfaction, feasibility, needs (FB-NB)', 'timeFrame': 'At month 4 (post-teatment, T1) and month 7 (follow-up, T2)', 'description': '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.'}, {'measure': 'Parent Stress Inventory (EBI)', 'timeFrame': 'At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).', 'description': 'The EBI measures the extent of parental stress and contains 48 items that are assigned to 12 subscales. Answering on a Likert scale.'}, {'measure': 'Crying, Feeding and Sleeping Questionnaire (SFS)', 'timeFrame': 'At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Demographic data', 'timeFrame': 'At baseline (before treatment, T0).', 'description': 'The questionnaire includes, among other things, the age, gender, ethnicity and socio-demographic data of the test subjects.'}, {'measure': 'Brief Symptom Inventory (BSI)', 'timeFrame': 'At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).', 'description': '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.'}, {'measure': 'Brief Infant Sleep Questionnaire (BISQ)', 'timeFrame': 'At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).', 'description': "The BISQ is a short and simple questionnaire about the child's sleep duration, nocturnal awakenings and methods of falling asleep."}, {'measure': 'Edinburgh Postnatal Depression Scale (EPDS)', 'timeFrame': 'At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).', 'description': 'The EPDS measures depression in the last 7 days with 10 items.'}, {'measure': 'Couple Conflict Questionnaire (PFB-K)', 'timeFrame': 'At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).', 'description': '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.'}, {'measure': 'Parent-Child Relationship Questionnaire (PBQ)', 'timeFrame': 'At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).', 'description': '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.'}, {'measure': 'Ulm Quality of Life Inventory for Parents (ULQIE)', 'timeFrame': 'At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).', 'description': '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).'}, {'measure': 'Ages & Stages Questionnaire®: Third Edition (ASQ-3)', 'timeFrame': 'At month 4 (post-teatment, T1) and month 7 (follow-up, T2).', 'description': '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.'}, {'measure': 'Focus groups', 'timeFrame': 'At baseline (before treatment, T0), after month 7 (follow-up, T1).', 'description': '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.'}, {'measure': 'App-questions', 'timeFrame': 'Every 14 days over a period of 4 months (baseline, T0 - post-treatment, T1).', 'description': "Questions about the child's and parents' state of health, well-being and perception of stress"}, {'measure': 'Questionnaire on health economics (HCU-Q)', 'timeFrame': 'At month 4 (post-teatment, T1) and month 7 (follow-up, T2).', 'description': "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."}, {'measure': 'Self-efficacy questionnaire (SWE)', 'timeFrame': 'At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).', 'description': "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)."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Preterm birth', 'E-health', 'Risk factors', 'Protective factors', 'Prevention'], 'conditions': ['Preterm Birth']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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, and again after 7 months, as well as through focus groups with study participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '34 Weeks', 'minimumAge': '28 Weeks', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Premature babies born at the UKT,\n* Gestational age 28-34 weeks,\n* Mother: age ≥ 18 years,\n* agreement to participate in this study and signing of a consent form,\n* sufficient knowledge of German,\n* internet access\n\nExclusion Criteria:\n\n* Premature babies \\< 28th or \\>34th week of pregnancy,\n* at least one of the children has serious diseases of the nervous system or obvious symptoms of a nervous disease,\n* at least one of the children has serious congenital diseases or suffers from malformations,\n* Mother: Lack of access to a smartphone/tablet,\n* no internet access,\n* insufficient knowledge of German'}, 'identificationModule': {'nctId': 'NCT06939192', 'acronym': 'NeoUp2', 'briefTitle': 'E-health-supported Diagnostic and Intervention in Preterm Born Children and Their Families', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Tuebingen'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '652/2023BO2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group (APP)', 'description': "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.", 'interventionNames': ['Other: Intervention Group (APP)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment as usual Group (TAU)', 'description': '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.', 'interventionNames': ['Other: Treatment as usual-Group (TAU)']}], 'interventions': [{'name': 'Intervention Group (APP)', 'type': 'OTHER', 'description': 'Combination of app-based information and diagnostic screening for parents of premature babies.', 'armGroupLabels': ['Intervention Group (APP)']}, {'name': 'Treatment as usual-Group (TAU)', 'type': 'OTHER', 'description': 'No intervention. Treatment in the form of usual aftercare service is possible.', 'armGroupLabels': ['Treatment as usual Group (TAU)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72076', 'city': 'Tübingen', 'state': 'Baden-Wurttemberg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Annette Conzelmann, Prof. Dr.', 'role': 'CONTACT', 'email': 'annette.conzelmann@med.uni-tuebingen.de', 'phone': '00497071/29-87513'}], 'facility': 'University Hospital Tuebingen', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}], 'centralContacts': [{'name': 'Annette Conzelmann, Prof.Dr.', 'role': 'CONTACT', 'email': 'annette.conzelmann@med.uni-tuebingen.de', 'phone': '00497071/29-87513'}, {'name': 'Annette Conzelmann, Prof. Dr.', 'role': 'CONTACT', 'email': 'annette.conzelmann@med.uni-tuebingen.de', 'phone': '00497071/29-87513'}], 'overallOfficials': [{'name': 'Annette Conzelmann, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University of Tübingen'}, {'name': 'Annika K Alt', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University of Tübingen'}, {'name': 'Tobias J Renner, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University of Tübingen'}, {'name': 'Axel Franz, Prof. Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'Neonatology, University of Tübingen'}, {'name': 'Mirja Quante, Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'Neonatology, University of Tübingen'}, {'name': 'Michaela Minarski, Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'Neonatology, University of Tübingen'}, {'name': 'Johanna Löchner, Prof. Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'Clinical Psychology, FAU Erlangen'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Any time before and after completion of the study for 10 years.', 'ipdSharing': 'YES', 'description': 'We share study material and statistical outputs.', 'accessCriteria': 'Upon request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Tuebingen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. Annette Conzelmann', 'investigatorFullName': 'PD Dr. Annette Conzelmann', 'investigatorAffiliation': 'University Hospital Tuebingen'}}}}