Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2026-03-04 @ 8:46 PM
Study NCT ID:
NCT01539356
Status:
COMPLETED
Last Update Posted:
2016-03-16
First Post:
2012-02-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hepcidin Levels in Preterm Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}, {'id': 'D000071074', 'term': 'Neonatal Sepsis'}, {'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-15', 'studyFirstSubmitDate': '2012-02-21', 'studyFirstSubmitQcDate': '2012-02-24', 'lastUpdatePostDateStruct': {'date': '2016-03-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Increase in Hepcidin levels by 30%', 'timeFrame': 'within 24-72 h'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hepcidin', 'Preterm Infants', 'Anemia', 'Sepsis', 'Ferritin'], 'conditions': ['Preterm Infants', 'Anemia of Prematurity', 'Neonatal Sepsis']}, 'referencesModule': {'references': [{'pmid': '22284565', 'type': 'BACKGROUND', 'citation': 'Muller KF, Lorenz L, Poets CF, Westerman M, Franz AR. Hepcidin concentrations in serum and urine correlate with iron homeostasis in preterm infants. J Pediatr. 2012 Jun;160(6):949-53.e2. doi: 10.1016/j.jpeds.2011.12.030. Epub 2012 Jan 28.'}, {'pmid': '19405934', 'type': 'BACKGROUND', 'citation': 'Yapakci E, Tarcan A, Celik B, Ozbek N, Gurakan B. Serum pro-hepcidin levels in term and preterm newborns with sepsis. Pediatr Int. 2009 Apr;51(2):289-92. doi: 10.1111/j.1442-200X.2008.02688.x.'}]}, 'descriptionModule': {'briefSummary': 'A recently isolated peptide hormone, hepcidin, is thought to be the principal regulator of iron homeostasis. Hepcidin acts by limiting intestinal iron absorption and promoting iron retention in reticuloendothelial cells. The aims of this study were to determine serum hepcidin levels in preterm infants who receive blood transfusion and preterm infants having sepsis, in order to assess possible relationships between hepcidin and serum iron, serum ferritin,in iron load situations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '37 Weeks', 'minimumAge': '24 Weeks', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Preterm \\< 38 weeks gestation Need of blood transfusion according to local Protocol. or signs and symptoms of sepsis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Preterm \\< 38 weeks gestation\n* Need of blood test for anemia or suspected sepsis\n\nExclusion Criteria:\n\n* Major congenital anomalies\n* Birth Asphyxia'}, 'identificationModule': {'nctId': 'NCT01539356', 'briefTitle': 'Hepcidin Levels in Preterm Infants', 'organization': {'class': 'OTHER', 'fullName': 'Meir Medical Center'}, 'officialTitle': 'Hepcidin Levels in Preterm Infants Receiving Blood Transfusion and During Sepsis.', 'orgStudyIdInfo': {'id': '0154-11-MMC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'preterm infants', 'description': 'preterm infants receiving blood transfusion\n\npreterm infants with neonatal sepsis.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '44281', 'city': 'Kfar Saba', 'country': 'Israel', 'facility': 'Neonatal Intensive Care Unit', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meir Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}