Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-25 @ 8:16 PM
Study NCT ID:
NCT04945369
Status:
RECRUITING
Last Update Posted:
2025-11-14
First Post:
2021-06-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Follow-up During the Peripubertal Period of Preterm Children Included in the Protocol Entitled "EPIPOD".
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 114}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2028-02-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-13', 'studyFirstSubmitDate': '2021-06-15', 'studyFirstSubmitQcDate': '2021-06-25', 'lastUpdatePostDateStruct': {'date': '2025-11-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-02-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Insulin resistance as measured by the Triglyceride-Glucose Index', 'timeFrame': '1 day'}], 'secondaryOutcomes': [{'measure': 'Insulin resistance as measured by the Homeostasis Model Assessment - Insulin Resistance index', 'timeFrame': '1 day'}, {'measure': 'Body composition (percentage of fat versus fat free mass) by BOP-POD and by impedancemetry (biodyXpert) for assessment of body composition variations between peripubertal period and neonatal period', 'timeFrame': '1 day'}, {'measure': 'creatinine clearance', 'timeFrame': '1 day'}, {'measure': 'Eating behaviour using standardized questionnaire named Child Eating Behaviour questionnaire', 'timeFrame': '1 day'}, {'measure': 'Eating behaviour using standardized french questionnaire named "QCAJE Questionnaire Comportement Alimentaire du Jeune Enfant"', 'timeFrame': '1 day'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Preterm Children']}, 'descriptionModule': {'briefSummary': 'Prematurity is associated with an increased risk of developing cardiovascular and metabolic disturbances in adulthood.\n\nIt has been demonstrated that the body composition of children born prematurely is different from that of children born under term with a deficit in fat free mass.\n\nIt can thus be wondered if this excessive adiposity does or does not predict the risk of insulin resistance in adulthood.\n\nChildren born prematurely, with a body composition measurement performed at discharge from neonatal hospitalization as part of the EPIPOD protocol, and now aged between 8 and 14 years, will be included in the INFANTPOD protocol.\n\nAnalysis of body composition, insulin resistance, renal function, pulse wave velocity, eating behaviour and of physical activity will be performed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Children hospitalised at the Nantes University Hospital in the neonatal period\n* With a body composition measurement performed at discharge from neonatal hospitalization as part of the EPIPOD protocol\n* Born prematurely (under 35 weeks of amenorrhea)\n* Included in the Lift cohort with follow-up up to 7 years\n* Aged between 8 and 14 years at inclusion\n\nExclusion Criteria:\n\n* Children with an isolated metabolic disease: insulin-dependent diabetes; endocrine disease (Cushing's, hypothyroidism)\n* Age of 15 years or more\n* with a chromosomal anomaly\n* with contraindicating measurement of the BOP-POD: ventilatory support, continuous parenteral feeding, elimination stoma\n* Refusal of either parent or child"}, 'identificationModule': {'nctId': 'NCT04945369', 'acronym': 'INFANTPOD', 'briefTitle': 'Follow-up During the Peripubertal Period of Preterm Children Included in the Protocol Entitled "EPIPOD".', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'Follow-up During the Peripubertal Period of Preterm Children (Under 35 Weeks of Amenorrhea) Included in the "EPIPOD" Protocol : Evaluation of Insulin Resistance', 'orgStudyIdInfo': {'id': 'RC20_0522'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Children born prematurely included in the EPIPOD protocol and now in the peripubertal period', 'description': 'At inclusion in the INFANTPOD study :\n\n* Blood and urinary samples collection for evaluation of insulin resistance and of renal function analysis.\n* Assessment of body composition by a commercialized device called "BOP-POD" and by impedancemetry\n* Assessment of pulse wave by a commercialized device called "popmetre"\n* Questionnaires for analysis of eating behaviour\n* Assessment of physical activity by a commercialized device called "accelerometer" and by questionnaire.', 'interventionNames': ['Other: clinical and biological measurements and questionnaires']}], 'interventions': [{'name': 'clinical and biological measurements and questionnaires', 'type': 'OTHER', 'description': 'Blood and urinary samples collection for evaluation of insulin resistance and of renal function analysis.\n\nAssessment of body composition by BOP-POD and by impedancemetry. Assessment of pulse wave by popmetre. Assessment of physical activity by accelerometer and by questionnaire Questionnaires for analysis of eating behaviour', 'armGroupLabels': ['Children born prematurely included in the EPIPOD protocol and now in the peripubertal period']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44600', 'city': 'Nantes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Anne FRONDAS, Doctor', 'role': 'CONTACT', 'email': 'anne.frondas@chu-nantes.fr', 'phone': '+33 2 40 08 34 83'}], 'facility': 'Nantes University Hospital', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}], 'centralContacts': [{'name': 'Anne FRONDAS, Doctor', 'role': 'CONTACT', 'email': 'anne.frondas@chu-nantes.fr', 'phone': '+33 2 40 08 34 83'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}