Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-02-27 @ 6:49 AM
Study NCT ID:
NCT02060851
Status:
COMPLETED
Last Update Posted:
2020-02-25
First Post:
2014-02-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Early Short-term Intravenous Iron Supplements Combined EPO in Preterm Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D044342', 'term': 'Malnutrition'}], 'ancestors': [{'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-24', 'studyFirstSubmitDate': '2014-02-09', 'studyFirstSubmitQcDate': '2014-02-09', 'lastUpdatePostDateStruct': {'date': '2020-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-02-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with Hematological evaluation', 'timeFrame': 'up to 2 weeks', 'description': 'Hematological evaluation including RBC, Hb, MCV, MCH, MCHC, RET, CRP were measured before and after the intervention. The three groups were all peripheral blood.'}], 'secondaryOutcomes': [{'measure': 'Iron storage', 'timeFrame': 'up to 2 weeks', 'description': 'Iron storage evaluation including ferritin, serum iron, TIBC on the days were measured before and after the intervention.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['EPO', 'Intravenous iron', 'iron storage', 'preterm anemia'], 'conditions': ['Malnutrition']}, 'descriptionModule': {'briefSummary': 'There are wide variations in iron supplementation practices in NICU.Guidelines on pediatric Parenteral nutrition suggested the dose of 200μg/kg.d iron by parenteral nutrition.', 'detailedDescription': 'The study was approved by the ethics committee of Xinhua Hospital, and all parents gave written informed consent.\n\nStudy Design This was a randomized, controlled, double-blind, interventional trial of iron (iron sucrose) supplementation given from age of 1 day until full 2 weeks to preterm infants in NICU, who divided into three groups, control(PN without iron and EPO), Vifor and vifor and EPOE group, according to the recommended dosage of ESPEN .\n\nOutcome Measures General information and indicators including anemia iron storage were measured. And the same time oxidative stress indicators were monitored at age of 1day and 2 weeks.\n\nGeneral growth parameters including the blood sugar, liver and renal function index before and after the intervention were tested.\n\nHematological evaluation including RBC, Hb, MCV, MCH, MCHC, RET, CRP were mesured before and after the intervention. The three groups were all peripheral blood.\n\nIron storage evaluation including ferritin, serum iron, TIBC on the days were measured before and after the intervention. We used the radio-immunoassay method to test the ferritin (DADE BEHRING, Germany), the chemical method to the serum iron and the automatic biochemical analyzer (automatic biochemical analyzer, 7600, HITACH).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '24 Hours', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Preterm infants with birth weight less than 2.5kg Have parenteral nutrition indication With written informed consent of parents or guardian\n\nExclusion Criteria:\n\n* Kidney and liver function abnormal have hemolytic disease have hemorrhagic disease have Serious congenital malformation have septicemia have plethora newborn use TPN less than ten days'}, 'identificationModule': {'nctId': 'NCT02060851', 'briefTitle': 'Effects of Early Short-term Intravenous Iron Supplements Combined EPO in Preterm Infants', 'organization': {'class': 'INDUSTRY', 'fullName': "Kunshan First People's Hospital Affiliated to Jiangsu University"}, 'officialTitle': 'Effects of Early Parenteral Iron Combined Erythropoietin in Preterm Infants', 'orgStudyIdInfo': {'id': 'kunshan002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vifor and EPO', 'description': 'intravenous iron and EPO', 'interventionNames': ['Drug: Vifor and EPO']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'control', 'description': 'no intravenous iron or EPO', 'interventionNames': ['Other: standard PN']}, {'type': 'EXPERIMENTAL', 'label': 'Vifor', 'description': 'intravenous iton but no EPO', 'interventionNames': ['Drug: Vifor']}], 'interventions': [{'name': 'standard PN', 'type': 'OTHER', 'otherNames': ['a control group'], 'description': 'Group 1: a control group who received standard PN', 'armGroupLabels': ['control']}, {'name': 'Vifor', 'type': 'DRUG', 'otherNames': ['an iron-supplemented group'], 'description': 'iron sucrose, 200 μg/kg per day, was given everyday with PN,', 'armGroupLabels': ['Vifor']}, {'name': 'Vifor and EPO', 'type': 'DRUG', 'otherNames': ['iron-supplemented combined EPO group'], 'description': 'EPO, 400U/kg, was given twice a week (Monday and Friday). IS, 200 μg/kg per day, was given everyday with PN, and the dose was continued until 2 weeks after birth', 'armGroupLabels': ['Vifor and EPO']}]}, 'contactsLocationsModule': {'locations': [{'zip': '215300', 'city': 'Kunshan', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Kunshan First Hospital', 'geoPoint': {'lat': 31.37762, 'lon': 120.95431}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Kunshan First People's Hospital Affiliated to Jiangsu University", 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "Ethics Committee of Kunshan First People's Hospital", 'investigatorFullName': 'Wang Hua', 'investigatorAffiliation': "Kunshan First People's Hospital Affiliated to Jiangsu University"}}}}