Ignite Creation Date:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2026-01-02 @ 7:55 AM
Study NCT ID:
NCT05238168
Status:
UNKNOWN
Last Update Posted:
2022-04-19
First Post:
2022-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Digital Follow up of Preterm Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D007859', 'term': 'Learning Disabilities'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D006130', 'term': 'Growth Disorders'}], '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'}, {'id': 'D003147', 'term': 'Communication Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-11', 'studyFirstSubmitDate': '2022-02-03', 'studyFirstSubmitQcDate': '2022-02-11', 'lastUpdatePostDateStruct': {'date': '2022-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ability to identify children and parents in need for further support/interventions questionnaire', 'timeFrame': '0-28 months', 'description': 'Digital follow up tool is compared to clinical follow up'}, {'measure': 'Response rate', 'timeFrame': '0-28 months', 'description': 'How many families responded at each time point'}], 'secondaryOutcomes': [{'measure': 'Parent satisfaction Questionnaire', 'timeFrame': '0-28 months', 'description': 'Questionnaire at each time point after the digital follow up and anonymous once yearly'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Preterm infant', 'Digital follow up', 'Electronic health monitoring'], 'conditions': ['Preterm Birth', 'Development Delay', 'Sensory Disorder', 'Growth Disorders', 'Family Relations']}, 'referencesModule': {'references': [{'pmid': '37612695', 'type': 'DERIVED', 'citation': 'Saarinen T, Ylijoki M, Lehtonen L, Munck P, Stolt S, Lapinleimu H, Rautava P, Haataja L, Setanen S, Leppanen M, Huhtala M, Saarinen K, Gronroos L, Korja R; PIPARI Study group. Web-based follow-up tool (ePIPARI) of preterm infants-study protocol for feasibility and performance. BMC Pediatr. 2023 Aug 23;23(1):413. doi: 10.1186/s12887-023-04226-4.'}]}, 'descriptionModule': {'briefSummary': 'The aim is to study how a digital follow up tool can identify the preterm born children and their families who need further support or clinical interventions', 'detailedDescription': 'This study runs a digital follow up parallel to clinical follow up, up to 2 years of corrected age of the child. It evaluates the ability of the digital follow up tool to identify the problems in growth and health, eating and feeding, neurodevelopment and parental wellbeing which require further support or interventions. This study includes all infants born under 34 weeks of gestation in Turku University Hospital during years 2019-2022 and those preterm children born under 32 weeks of gestation who turn to 2 years during years 2019-2021.\n\nParent satisfaction about the digital follow up tool is asked at each time point and anonymously once per year. The follow up age points are the expected day of birth, 1 month, 2 months, 4 months, 8 months, 12 months, 18 months and 24 months after the expected birth date.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '28 Months', 'minimumAge': '1 Month', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Preterm infants treated in a neonatal intensive care unit and their parents.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children born before 34 weeks fo gestation and their parents\n* Clinical follow up at Turku University Hospital\n\nExclusion Criteria:\n\n* Parents do not speak Finnish, Swedish or English'}, 'identificationModule': {'nctId': 'NCT05238168', 'acronym': 'ePIPARI', 'briefTitle': 'Evaluation of Digital Follow up of Preterm Infants', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Turku University Hospital'}, 'officialTitle': 'ePIPARI - Digital Follow-up of Preterm Infants During First Two Years', 'orgStudyIdInfo': {'id': 'T200/2018'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ePIPARI digital follow up tool', 'type': 'OTHER', 'description': 'A digital platform includes questions to parents about child wellbeing and development and parent wellbeing. A notification by email or app comes two weeks before the follow up time point. The parents respond via a link to a webpage or via an app.They also receive information (text and video) about age-appropriate child development. ePIPARI includes 8 assessment points from term age until 2 years of corrected age.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20500', 'city': 'Turku', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'NICU/Pediatrics', 'role': 'CONTACT', 'email': 'liisa.lehtonen@tyks.fi', 'phone': '+358408318322'}], 'facility': 'NICU/Pediatrics', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}], 'centralContacts': [{'name': 'Liisa Lehtonen, MD', 'role': 'CONTACT', 'email': 'lianle@utu.fi', 'phone': '+358408318322'}, {'name': 'Milla Ylijoki, MD', 'role': 'CONTACT', 'email': 'mikare@utu.fi', 'phone': '+358440781455'}], 'overallOfficials': [{'name': 'Liisa Lehtonen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Turku University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Turku University Hospital', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'University of Turku', 'class': 'OTHER'}, {'name': 'University of Helsinki', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Liisa Lehtonen', 'investigatorAffiliation': 'Turku University Hospital'}}}}