Ignite Creation Date:
2025-12-24 @ 3:07 PM
Ignite Modification Date:
2026-02-23 @ 9:22 PM
Study NCT ID:
NCT02515292
Status:
UNKNOWN
Last Update Posted:
2015-08-06
First Post:
2015-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Infants With Intrauterine Growth Restriction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005317', 'term': 'Fetal Growth Retardation'}], 'ancestors': [{'id': 'D005315', 'term': 'Fetal Diseases'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006130', 'term': 'Growth Disorders'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2016-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-08-04', 'studyFirstSubmitDate': '2015-07-29', 'studyFirstSubmitQcDate': '2015-07-31', 'lastUpdatePostDateStruct': {'date': '2015-08-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of serum IGF2', 'timeFrame': 'baseline', 'description': 'serum IGF2'}, {'measure': 'Evaluation of IGF2 receptors', 'timeFrame': 'baseline', 'description': 'serum IGF2 receptors'}], 'secondaryOutcomes': [{'measure': 'Genetic evaluation', 'timeFrame': 'baseline', 'description': "Number of subjects homozygous (A or G) and heterozygous (A/G) using forward primer: 5'- CTTGGACTTTGAGTCAAATTGG-3' and reverse primer: 5'-GGTCGTGCCAATTACATTTCA-3' genetic expression of IGF2 receptors. The groups will be evaluated in regards of polymorphism and allele frequencies."}, {'measure': 'Clinical assessment', 'timeFrame': 'baseline', 'description': 'Number of cases with respiratory distress, hyperbilirubinemia, early and late sepsis, hypoglicemia, necrozant enterocolitis or other co-morbidities.'}, {'measure': 'Cardiac morphological and functional evaluation', 'timeFrame': 'baseline and follow-up (1 month and/or 6 months)', 'description': 'Eco cardiac measurements will be performed to all participants and the morphological and functional data will be recorded baseline for all participant (IUGR and controls). As results number of subjects with cardiac morphological and functional evaluation will be according with subjects included in the study and those subjects with cardiac modification or those from case group will be evaluated dynamically.'}]}, 'conditionsModule': {'keywords': ['IUGR (intrauterine growth restriction)', 'IGF2 (insulin-like growth factor 2)', 'morbidity'], 'conditions': ['Intrauterine Growth Restriction']}, 'descriptionModule': {'briefSummary': 'Purpose: Clinical assessment (anthropometric) and paraclinical (biochemical and immunological by dosing serum insuline growth factors IGF1 and IGF2 and their receptors) of neonates with intrauterine growth restriction (IUGR) and the integration in a multidimensional statistical model .\n\nObjectives:\n\n1. IGF1 and IGF2 evaluation of serum and IGF1 receptor, IGF2 receptor and IGF2 receptor gene expression in cord blood from newborns with intrauterine growth restriction (IUGR). (Prospective)\n2. Evaluation and monitoring of anthropometric, clinical (non-cardiac morbidity) and paraclinical. (Retrospective \\& prospective)\n3. Evaluation and monitoring of morphological and functional by echocardiography. (Prospective)\n4. Integrating multidimensional clinical and paraclinical parameters in a statistical model for evaluating newborn with intrauterine growth restriction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '24 Hours', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Population with IUGR from a 3rd level maternity from Nord-West of Romania', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* newborns with intrauterine growth restriction (IUGR): weight below the 10th percentile for gestational age\n* parental consent for enrollment\n\nExclusion Criteria:\n\n* IUGR neonates in the context chromosomopathies: trisomy 21, trisomy 18.\n* neonates with congenital heart disease\n* twins\n* refusal of parents for participation to the study'}, 'identificationModule': {'nctId': 'NCT02515292', 'acronym': 'ModeInfIUGR', 'briefTitle': 'Evaluation of Infants With Intrauterine Growth Restriction', 'organization': {'class': 'OTHER', 'fullName': 'Iuliu Hatieganu University of Medicine and Pharmacy'}, 'officialTitle': 'Multidimensional Modeling in Evaluation of Infants With Intrauterine Growth Restriction', 'orgStudyIdInfo': {'id': '142 /181/ 20.05.2014'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'IUGR: newborn with intrauterine growth restriction', 'description': 'Inclusion criteria:\n\n* newborn infants with symmetrical (both weight and height lower than 10th percentile) or asymmetrical (birth weight is lower than 10th percentile but height and age-appropriated height) intrauterine growth restriction\n* agreement of the parents that their child to be included in the study'}, {'label': 'control: newborn without intrauterine growth restriction', 'description': 'Inclusion criteria:\n\n\\- matches newborn without intrauterine growth restriction in terms of gender and gestational age as IUGR group'}]}, 'contactsLocationsModule': {'locations': [{'zip': '400006', 'city': 'Cluj-Napoca', 'state': 'Cluj', 'status': 'RECRUITING', 'country': 'Romania', 'contacts': [{'name': 'Monica Hăşmăşanu, MD', 'role': 'CONTACT', 'email': 'popa.monica@umfcluj.ro', 'phone': '+40741985974'}, {'name': 'Sorana D. Bolboacă, PhD Habil, MD', 'role': 'CONTACT', 'email': 'sbolboaca@umfcluj.ro', 'phone': '+40750774506'}], 'facility': 'Neonatal-Ward, 1st Gynecology Clinic', 'geoPoint': {'lat': 46.76667, 'lon': 23.6}}], 'centralContacts': [{'name': 'Monica Gabriela Hășmășanu, MD', 'role': 'CONTACT', 'email': 'popa.monica@umfcluj.ro', 'phone': '+40741985974'}, {'name': 'Sorana D. Bolboacă, PhD Habil', 'role': 'CONTACT', 'email': 'sbolboaca@umfcluj.ro', 'phone': '+40750774506'}], 'overallOfficials': [{'name': 'Gabriela Zaharie, PhD, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Iuliu Hațieganu Medicine and pharmacy University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Iuliu Hatieganu University of Medicine and Pharmacy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Hășmășanu Monica Gabriela', 'investigatorAffiliation': 'Iuliu Hatieganu University of Medicine and Pharmacy'}}}}