Ignite Creation Date:
2025-12-24 @ 5:29 PM
Ignite Modification Date:
2026-01-01 @ 3:41 PM
Study NCT ID:
NCT06270368
Status:
RECRUITING
Last Update Posted:
2024-02-21
First Post:
2024-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Children Born Preterm: Sustainable Health Monitoring
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 650}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-08-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-20', 'studyFirstSubmitDate': '2024-02-12', 'studyFirstSubmitQcDate': '2024-02-20', 'lastUpdatePostDateStruct': {'date': '2024-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Infant development', 'timeFrame': 'The measurements will be assessed at 20-28 months of age', 'description': 'Infant development comprises physical, cognitive, social-emotional, linguistic, and behavioral milestones. Infant development is assessed with the Bayley Scales Of Infant and Toddler Development third edition (Bayley - III).'}, {'measure': 'Childhood development', 'timeFrame': 'The measurements will be assessed at 56-66 months of age', 'description': 'Childhood development comprises physical, cognitive, social-emotional, linguistic, and behavioral milestones. Childhood development is assessed with the Ages and Stages Questionnaires (ASQ-3).'}], 'secondaryOutcomes': [{'measure': 'Presence of visual or hearing impairement', 'timeFrame': 'The measurements will be assessed at 20-28 months of age and at 56-66 months of age'}, {'measure': 'Presence of asthma', 'timeFrame': 'The measurements will be assessed at 56-66 months of age'}, {'measure': 'Access to care', 'timeFrame': 'The measurements will be assessed at 20-28 months of age and at 56-66 months of age', 'description': 'Hospitalizations and surgeries occurred in the last 12 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Premature Birth']}, 'descriptionModule': {'briefSummary': 'Children born preterm are recognized to be at higher risk of short and long term complications and a formal follow-up of infants and children born preterm is recommended by international and national scientific societies. However, in Italy as well as in Tuscany, such a follow up is not usually done, and data are not collected in a structured way. The goal of this observational study is to evaluate the association between a large number of early life exposures and health outcomes and access to care during childhood in infants born preterm. The main questions it aims to answer are: • what is the role of prenatal and perinatal factors in influencing health outcomes during childhood in preterm infants? • What is the role of prenatal and perinatal factors in influencing access to care during childhood? Participants will be asked to attend a follow-up visit for the purpose of collecting health data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '66 Months', 'minimumAge': '20 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Preterm infants who were born and reside in the Tuscany region.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children born preterm (gestational age below 37 weeks at birth) in Tuscany Region\n* Acquisition of the informed consent\n\nExclusion Criteria:\n\n* Residing outside Tuscany region'}, 'identificationModule': {'nctId': 'NCT06270368', 'briefTitle': 'Children Born Preterm: Sustainable Health Monitoring', 'organization': {'class': 'OTHER', 'fullName': "Meyer Children's Hospital IRCCS"}, 'officialTitle': 'Children Born Preterm: Sustainable Health Monitoring', 'orgStudyIdInfo': {'id': 'PREHMO'}}, 'contactsLocationsModule': {'locations': [{'city': 'Florence', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Simone Pratesi', 'role': 'CONTACT'}], 'facility': 'Azienda Ospedaliero-Universitaria Careggi (AOUC)', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'city': 'Florence', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Vieri Lastrucci', 'role': 'CONTACT', 'email': 'vieri.lastrucci@meyer.it'}], 'facility': "Meyer Children's Hospital IRCCS", 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'city': 'Pisa', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Rosa Scaramuzzo', 'role': 'CONTACT'}], 'facility': 'Azienda Ospedaliero Universitaria Pisana (AOUP)', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}, {'city': 'Siena', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Carlo Valerio Bellieni', 'role': 'CONTACT'}], 'facility': 'Azienda Ospedaliero Universitaria Senese (AOUS)', 'geoPoint': {'lat': 43.31822, 'lon': 11.33064}}], 'centralContacts': [{'name': 'Vieri Lastrucci', 'role': 'CONTACT', 'email': 'vieri.lastrucci@meyer.it', 'phone': '+393297487648'}, {'name': 'Elettra Berti', 'role': 'CONTACT', 'email': 'elettra.berti@meyer.it'}], 'overallOfficials': [{'name': 'Vieri Lastrucci, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Meyer Children's Hospital IRCCS"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Meyer Children's Hospital IRCCS", 'class': 'OTHER'}, 'collaborators': [{'name': 'IRCCS Fondazione Stella Maris', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Vieri Lastrucci', 'investigatorAffiliation': "Meyer Children's Hospital IRCCS"}}}}